Nausea, Vomiting
Conditions
Keywords
nausea, vomiting, antiemetics, radiotherapy, Radiation-induced nausea and vomiting
Brief summary
The primary objective of this pilot study is to examine the efficacy of Aprepitant given in combination with Granisetron for the prevention of delayed-phase RINV in 84 patients receiving a single 8Gy of moderately emetogenic palliative RT in the RRRP at Sunnybrook Odette Cancer Centre for painful bony metastases from any primary solid tumor. Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.. Secondary objectives include determining the complete RINV prophylaxis rate (acute and delayed phases), the partial emesis control rate, the safety of the combined regime, QOL issues, the time to the first emetic event and the time to the first use of rescue medication .
Interventions
DRUGAprepitant
Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
RADIATIONPalliative radiation therapy
Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.
DRUGGranisetron
Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT).
Sponsors
Merck Frosst Canada Ltd.
Sunnybrook Health Sciences Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with bone metastases from any primary solid tumor site scheduled to receive a single 8 Gy fraction of palliative radiotherapy considered to be moderately emetogenic (an area of at least 80 cm2 in the anterior/posterior direction and located between the level of upper border of T11 and the lower border of L3) in the RRRP at Sunnybrook Odette Cancer Centre will be considered eligible.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients Experiencing no Vomiting and no Nausea, Without Use of Any Rescue Antiemetic Medication(s), From Days 2-10 Following the Radiation Therapy (Delayed RINV). | Days 2-10 following radiotherapy | Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Complete RINV Prophylaxis Rate (Acute and Delayed Phases), the Partial Emesis Control Rate, the Safety of the Combined Regime, QOL Issues, the Time to the First Emetic Event and Use of Rescue Medication . | From day of radiotherapy to 10 days following radiotherapy | Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame. |
| Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy | Day of radiotherapy and 24 hours following | Percentage of participants experiencing no nausea, vomiting, and retching during the acute phase was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily following the radiation therapy based on patient self-report nausea/vomiting diaries. |
| Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy | Days 2-10 following radiotherapy | Percentage of participants in the single fraction arm experiencing no nausea, vomiting, and retching was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries. |
| Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy | During radiotherapy (5 days) and the 24 hours following radiotherapy | Percentage of participants in the multiple fraction arm experiencing no nausea, vomiting, and retching was assessed. Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame. |
| Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy | Days 2-10 following radiotherapy | Percentage of participants experiencing no nausea, vomiting, and retching was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries. |
Countries
Canada
Participant flow
Recruitment details
Patients were enrolled between January 2011 and October 2012 in a radiation oncology clinic
Pre-assignment details
No enrolled patients were later excluded.
Participants by arm
| Arm | Count |
|---|---|
| Aprepitant and Granisetron Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Aprepitant and Granisetron |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 15.48 |
| Region of Enrollment Canada | 19 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
The Proportion of Patients Experiencing no Vomiting and no Nausea, Without Use of Any Rescue Antiemetic Medication(s), From Days 2-10 Following the Radiation Therapy (Delayed RINV).
Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.
Time frame: Days 2-10 following radiotherapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aprepitant and Granisetron | The Proportion of Patients Experiencing no Vomiting and no Nausea, Without Use of Any Rescue Antiemetic Medication(s), From Days 2-10 Following the Radiation Therapy (Delayed RINV). | 19 participants |
Secondary
Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy
Percentage of participants in the multiple fraction arm experiencing no nausea, vomiting, and retching was assessed. Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame.
Time frame: During radiotherapy (5 days) and the 24 hours following radiotherapy
Population: Patients undergoing multiple fraction treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aprepitant and Granisetron | Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy | Control rate of acute phase nausea | 67 percentage of participants |
| Aprepitant and Granisetron | Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy | Control rate of acute phase vomiting/retching | 67 percentage of participants |
Secondary
Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy
Percentage of participants experiencing no nausea, vomiting, and retching during the acute phase was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily following the radiation therapy based on patient self-report nausea/vomiting diaries.
Time frame: Day of radiotherapy and 24 hours following
Population: Patients undergoing single fraction treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aprepitant and Granisetron | Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy | Control rate of acute phase nausea | 100 percentage of participants |
| Aprepitant and Granisetron | Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy | Control rate of acute phase vomiting/retching | 100 percentage of participants |
Secondary
Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy
Percentage of participants experiencing no nausea, vomiting, and retching was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.
Time frame: Days 2-10 following radiotherapy
Population: Patients undergoing multiple fraction treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aprepitant and Granisetron | Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy | Control rate of delayed phase nausea | 83 percentage of participants |
| Aprepitant and Granisetron | Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy | Control rate of delayed phase vomiting/retching | 83 percentage of participants |
Secondary
Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy
Percentage of participants in the single fraction arm experiencing no nausea, vomiting, and retching was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.
Time frame: Days 2-10 following radiotherapy
Population: Patients undergoing single fraction treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aprepitant and Granisetron | Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy | Control rate of delayed phase nausea | 62 percentage of participants |
| Aprepitant and Granisetron | Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy | Control rate of delayed phase vomiting/retching | 85 percentage of participants |
Secondary
The Complete RINV Prophylaxis Rate (Acute and Delayed Phases), the Partial Emesis Control Rate, the Safety of the Combined Regime, QOL Issues, the Time to the First Emetic Event and Use of Rescue Medication .
Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame.
Time frame: From day of radiotherapy to 10 days following radiotherapy