Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study
Information source: Sunnybrook Health Sciences Centre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea; Vomiting
Intervention: Aprepitant (Drug); Palliative radiation therapy (Radiation); Granisetron (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Sunnybrook Health Sciences Centre Official(s) and/or principal investigator(s): Edward Chow, MBBS PhD FRCPC, Principal Investigator, Affiliation: Odette Cancer Centre, Sunnybrook Health Sciences Centre
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 .
Clinical Details
Official title: Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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).
Secondary outcome: 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 .Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario M4N3M5, Canada
Additional Information
Starting date: January 2011
Last updated: November 17, 2014
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