Emesis
Conditions
Keywords
Nausea, Vomiting
Brief summary
For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting) control compared with standard anti-emetic regimen. The risk calculator has the potential to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate anti-emetic regimen in patients at high risk.
Interventions
DRUGDexamethasone, Ondansetron, Aprepitant
Arm B participants will be given doses of anti-emetics based on the emesis risk calculation. Doses will vary depending on the which level they fall into level 0, level 1, 2 or 3 based on the participant's diary.
OTHERArm A: Standard Anti-emetic regimen
Treating physician's discretion for type of anti-emetic to be prescribed.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Newly diagnosed invasive breast cancer (stage I-III) Scheduled to receive neoadjuvant or adjuvant intravenous anthracycline with cyclophosphamide-based chemotherapy; Able to consent and fill study forms
Exclusion criteria
Received previous chemotherapy Symptoms of nausea or vomiting at baseline (disease related) On chronic anti-emetic therapy On daily corticosteroids prior to initiation of chemotherapy Allergic to steroids, 5HT3 or NK-1 Uncontrolled diabetes Medical or psychiatric illness that would interfere with patients' ability to complete the diary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of change in acute emesis (nausea and/or vomiting) in both study arms | Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks | The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains-one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, minimal or no impact of CINV on daily life is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms | Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks | The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains-one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, minimal or no impact of CINV on daily life is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference in breakthrough anti-emetic use in the emesis risk model group compared to the standard arm; i.e.: requirements for additional oral and parenteral anti-emetics during a single chemotherapy cycle | Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks | The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains-one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, minimal or no impact of CINV on daily life is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines. |
Countries
Canada
Outcome results
None listed