Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study
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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 .
Condition | Intervention | Phase |
---|---|---|
Nausea Vomiting |
Drug: Aprepitant |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
Official Title: | Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study |
- 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). [ Time Frame: Days 2-10 following radiotherapy ] [ Designated as safety issue: No ]Measurements will be taken daily within this time with patient self-report nausea diaries.
- 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 . [ Time Frame: From day of radiotherapy to 10 days following radiotherapy ] [ Designated as safety issue: No ]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.
Estimated Enrollment: | 84 |
Study Start Date: | December 2010 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: 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.
|
Drug: Aprepitant
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.
|
Genders Eligible for Study: | Both |
Accepts 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:
- Exclusion criteria include having nausea or vomiting 24hrs prior to radiation
- Having received or being scheduled to receive cranial radiation, moderately or highly emetogenic cytotoxic therapy 7 days prior to, during, or after radiation, receiving corticosteroids (except inhaled or topical), 5HT3 receptor antagonists or NK-1 antagonists or other antiemetic medication, being allergic to study medications, having a KPS<40, being pregnant or of childbearing potential and not using contraceptive measures.
Canada, Ontario | |
Odette Cancer Centre, Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N3M5 |
Principal Investigator: | Edward Chow, MBBS PhD FRCPC | Odette Cancer Centre, Sunnybrook Health Sciences Centre |
No publications provided
Responsible Party: | Dr Edward Chow, Odette Cancer Centre, Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT01183481 History of Changes |
Other Study ID Numbers: | RINV Prophylaxis |
Study First Received: | August 4, 2010 |
Last Updated: | December 15, 2010 |
Health Authority: | Canada: Health Canada |
Keywords provided by Sunnybrook Health Sciences Centre:
nausea vomiting antiemetics radiotherapy Radiation-induced nausea and vomiting |
Additional relevant MeSH terms:
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Granisetron Aprepitant Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012