Nausea, Vomiting
Conditions
Brief summary
The primary objective of the study is to examine the efficacy of Ondissolve for the prevention/rescue of Acute and Delayed Phase radiation induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. The study population will be 30 patients seen in the RRRP at the Sunnybrook Odette Cancer Centre receiving palliative radiation therapy considered emetogenic for bone metastases. Patients will take the study medication (Ondissolve 8 mg) twice on each day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8 hours later the same day. Patients undergoing multiple fraction radiation therapy will take Ondissolve on weekends or holidays in between treatment. Secondary objectives include to evaluate key secondary endpoints related to RINV, and to investigate the ease and length of administration of protocol medicine. We hypothesize that Ondissolve will be effective in the prophylaxis of RINV, and the ease of use and administration will provide an appropriate delivery method for those unable to tolerate the oral form of ondansetron.
Interventions
DRUGOndansetron
Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.
Sponsors
Takeda Canada, Inc.
Sunnybrook Health Sciences Centre
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Patient will receive palliative radiation therapy considered emetogenic for bone metastases. * Group 1: At least mild nausea and/or at least mild vomiting as recorded in the Baseline Nausea and Vomiting Data Collection Sheet * Group 2: Nausea and vomiting recorded as 'none' in the Baseline Nausea and Vomiting Data Collection Sheet
Exclusion criteria
* Patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol RT. * Patient received cranial RT within 7 days prior to commencement of protocol RT. * Patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol RT. * Patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol RT. * Patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity within 48 hours of protocol RT. * Patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity during or within 10 days following completion of protocol RT. * Patient is allergic to protocol medication. * Patient has a Karnofsky Performance Status score \<40. * Patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Day 0 - Day 10 | The primary objectives are to examine the efficacy for the prevention/rescue of Acute and Delayed Phase radiation-induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline. Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy. Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Day 0-5 during treatment | Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning. |
| The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Day 6-10 of treatment | Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning. |
| Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Day 3 | Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life. Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days. Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family? |
| Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Day 7 | Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life. Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days. Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family? |
Countries
Canada
Participant flow
Recruitment details
Patients attending the Odette Cancer Centre, Toronto, Canada, who satisfy the eligibility criteria were considered for entry into the trial. The last patient was enrolled July 2014.
Pre-assignment details
This prospective phase II trial enrolled patients from November 2013 to July 2014.
Participants by arm
| Arm | Count |
|---|---|
| Primary Prophylaxis Patients had no nausea or vomiting at baseline. | 26 |
| Secondary Prophylaxis Patients had nausea or vomiting at baseline. | 4 |
| Total | 30 |
Baseline characteristics
| Characteristic | Primary Prophylaxis | Secondary Prophylaxis | Total |
|---|---|---|---|
| Age, Continuous | 71.6 years STANDARD_DEVIATION 11.7 | 69.8 years STANDARD_DEVIATION 5.7 | 71.3 years STANDARD_DEVIATION 11 |
| Location Home | 24 Participants | 4 Participants | 28 Participants |
| Location Hospital | 2 Participants | 0 Participants | 2 Participants |
| Primary cancer site Bladder | 2 Participants | 0 Participants | 2 Participants |
| Primary cancer site Breast | 8 Participants | 0 Participants | 8 Participants |
| Primary cancer site Lung | 2 Participants | 1 Participants | 3 Participants |
| Primary cancer site Other | 3 Participants | 1 Participants | 4 Participants |
| Primary cancer site Prostate | 10 Participants | 1 Participants | 11 Participants |
| Primary cancer site Unknown | 1 Participants | 1 Participants | 2 Participants |
| Radiotherapy dose 20 Gy in 5 fractions | 6 Participants | 0 Participants | 6 Participants |
| Radiotherapy dose 30 Gy in 10 fractions | 4 Participants | 0 Participants | 4 Participants |
| Radiotherapy dose 8 Gy in 1 fraction | 16 Participants | 4 Participants | 20 Participants |
| Score on the KPS | 69.2 units on a scale STANDARD_DEVIATION 15.2 | 70.0 units on a scale STANDARD_DEVIATION 14.1 | 69.3 units on a scale STANDARD_DEVIATION 14.8 |
| Sex: Female, Male Female | 10 Participants | 1 Participants | 11 Participants |
| Sex: Female, Male Male | 16 Participants | 3 Participants | 19 Participants |
| Systemic treatment Bisphosphonate only | 2 Participants | 0 Participants | 2 Participants |
| Systemic treatment Chemotherapy | 7 Participants | 1 Participants | 8 Participants |
| Systemic treatment Hormone therapy | 4 Participants | 0 Participants | 4 Participants |
| Systemic treatment None | 13 Participants | 3 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
The primary objectives are to examine the efficacy for the prevention/rescue of Acute and Delayed Phase radiation-induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline. Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy. Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication.
Time frame: Day 0 - Day 10
Population: The results here encompass the primary outcome measure the proportion of patients with complete prophylaxis and partial control, which is repeated in the secondary outcome. The secondary outcome Time to nausea, vomiting and/or use of rescue medication is unavailable due to the data not being collected/analysed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Nausea | Complete control | 21 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Nausea | Partial control | 2 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Nausea | Uncontrolled | 3 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Vomiting | Complete control | 25 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Vomiting | Partial control | 1 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Vomiting | Uncontrolled | 2 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Nausea | Complete control | 18 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Nausea | Partial control | 1 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Nausea | Uncontrolled | 7 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Vomiting | Complete control | 21 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Vomiting | Partial control | 0 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Vomiting | Uncontrolled | 7 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Nausea | Complete control | 17 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Nausea | Partial control | 1 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Nausea | Uncontrolled | 8 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Vomiting | Complete control | 21 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Vomiting | Partial control | 0 Participants |
| Primary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Vomiting | Uncontrolled | 7 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Nausea | Partial control | 0 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Nausea | Complete control | 4 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Vomiting | Complete control | 1 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Nausea | Partial control | 0 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Vomiting | Uncontrolled | 1 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Nausea | Uncontrolled | 0 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Vomiting | Partial control | 0 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Vomiting | Complete control | 2 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Nausea | Uncontrolled | 2 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Vomiting | Partial control | 0 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Vomiting | Uncontrolled | 1 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Acute-Vomiting | Uncontrolled | 0 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Vomiting | Partial control | 0 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Nausea | Complete control | 2 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Nausea | Complete control | 2 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Nausea | Partial control | 0 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Combined-Vomiting | Complete control | 1 Participants |
| Secondary Prophylaxis | Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting. | Delayed-Nausea | Uncontrolled | 2 Participants |
Other Pre-specified
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life. Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days. Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?
Time frame: Day 3
Population: Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q2 nausea affecting leisure activities | 1.31 units on a scale | Standard Error 0.43 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q3 nausea affecting ability to do house work | 1.21 units on a scale | Standard Error 0.81 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q4 nausea affecting enjoyment of meals | 1.40 units on a scale | Standard Error 1.19 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q5 nausea affecting enjoyment of refreshments | 1.17 units on a scale | Standard Error 0.46 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q6 nausea affecting spending time with loved ones | 1.10 units on a scale | Standard Error 0.4 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q7 nausea affecting daily functioning | 1.13 units on a scale | Standard Error 0.43 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q8 nausea imposing personal hardship | 1.20 units on a scale | Standard Error 0.55 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q9 nausea imposing hardship on others | 1.13 units on a scale | Standard Error 0.51 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q11 vomiting affecting leisure activities | 1.03 units on a scale | Standard Error 0.18 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q12 vomiting affecting ability to do house work | 1 units on a scale | Standard Error 0 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q13 vomiting affecting enjoyment of meals | 1.03 units on a scale | Standard Error 0.18 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q14 vomiting affecting enjoyment of refreshments | 1.03 units on a scale | Standard Error 0.18 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q15 vomiting affecting spending time with loved on | 1.03 units on a scale | Standard Error 0.18 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q16 vomiting affecting daily functioning | 1.03 units on a scale | Standard Error 0.19 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q17 vomiting imposing personal hardship | 1.07 units on a scale | Standard Error 0.25 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q18 vomiting imposing hardship on others | 1.03 units on a scale | Standard Error 0.18 |
Other Pre-specified
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life. Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days. Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?
Time frame: Day 7
Population: Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q2 nausea affecting leisure activities | 1.23 units on a scale | Standard Error 0.82 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q3 nausea affecting ability to do house work | 1.19 units on a scale | Standard Error 0.69 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q4 nausea affecting enjoyment of meals | 1.37 units on a scale | Standard Error 1.01 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q5 nausea affecting enjoyment of refreshments | 1.15 units on a scale | Standard Error 0.6 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q6 nausea affecting spending time with loved ones | 1.19 units on a scale | Standard Error 0.56 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q7 nausea affecting daily functioning | 1.19 units on a scale | Standard Error 0.56 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q8 nausea imposing personal hardship | 1.26 units on a scale | Standard Error 0.71 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q9 nausea imposing hardship on others | 1.22 units on a scale | Standard Error 0.8 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q11 vomiting affecting leisure activities | 1.19 units on a scale | Standard Error 0.68 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q12 vomiting affecting ability to do house work | 1.19 units on a scale | Standard Error 0.68 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q13 vomiting affecting enjoyment of meals | 1.30 units on a scale | Standard Error 1.2 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q14 vomiting affecting enjoyment of refreshments | 1.30 units on a scale | Standard Error 1.2 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q15 vomiting affecting spending time with loved on | 1.15 units on a scale | Standard Error 0.6 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q16 vomiting affecting daily functioning | 1.19 units on a scale | Standard Error 0.68 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q17 vomiting imposing personal hardship | 1.19 units on a scale | Standard Error 0.56 |
| Primary Prophylaxis | Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives) | Q18 vomiting imposing hardship on others | 1.12 units on a scale | Standard Error 0.43 |
Other Pre-specified
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.
Time frame: Day 0-5 during treatment
Population: The primary prophylaxis arm and secondary prophylaxis arm patients were combined and analysed together, because the secondary prophylaxis arm had only 4 patients, which was too low to draw any meaningful conclusions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Pain | 50.6 units on a scale | Standard Deviation 31 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Dyspnea | 24.1 units on a scale | Standard Deviation 25 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Insomnia | 34.5 units on a scale | Standard Deviation 33.9 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Appetite loss | 36.8 units on a scale | Standard Deviation 36 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Constipation | 27.6 units on a scale | Standard Deviation 34.6 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Overall quality of life | 47.7 units on a scale | Standard Deviation 24.3 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Physical functioning | 49.0 units on a scale | Standard Deviation 36.2 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Fatigue | 54.8 units on a scale | Standard Deviation 34.4 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Nausea/vomiting | 5.75 units on a scale | Standard Deviation 19 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment. | Emotional functioning | 69.2 units on a scale | Standard Deviation 25.8 |
Other Pre-specified
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.
Time frame: Day 6-10 of treatment
Population: Combined patients from primary prophylaxis and secondary prophylaxis arms, due to the low number of patients in the secondary prophylaxis arm (n=4).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Pain | 49.4 units on a scale | Standard Deviation 32.5 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Dyspnea | 25.9 units on a scale | Standard Deviation 31.1 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Insomnia | 44.4 units on a scale | Standard Deviation 33.3 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Appetite loss | 38.3 units on a scale | Standard Deviation 36.6 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Constipation | 27.1 units on a scale | Standard Deviation 34.6 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Overall quality of life | 47.7 units on a scale | Standard Deviation 24.3 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Physical functioning | 49.0 units on a scale | Standard Deviation 36.2 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Fatigue | 54.8 units on a scale | Standard Deviation 34.4 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Nausea/vomiting | 5.75 units on a scale | Standard Deviation 19 |
| Primary Prophylaxis | The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment. | Emotional functioning | 69.2 units on a scale | Standard Deviation 25.8 |