Status:
TERMINATED
Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Merck Frosst Canada Ltd.
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01183481
Start Date
January 1 2011
End Date
March 1 2013
Last Update
October 9 2019
Active Locations (1)
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1
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5