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Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study

Phase 2
Not Enrolling
Nausea, Vomiting

Thank you

Trial Information

Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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).

Outcome Description:

Measurements will be taken daily within this time with patient self-report nausea diaries.

Outcome Time Frame:

Days 2-10 following radiotherapy

Safety Issue:


Principal Investigator

Edward Chow, MBBS PhD FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Odette Cancer Centre, Sunnybrook Health Sciences Centre


Canada: Health Canada

Study ID:

RINV Prophylaxis



Start Date:

December 2010

Completion Date:

March 2013

Related Keywords:

  • Nausea
  • Vomiting
  • nausea
  • vomiting
  • antiemetics
  • radiotherapy
  • Radiation-induced nausea and vomiting
  • Nausea
  • Vomiting