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

Phase 2

Terminated

Conditions: Nausea
Vomiting

Interventions: Drug: Aprepitant
Radiation: Palliative radiation therapy
Drug: Granisetron

Registration Number: NCT01183481

Lead Sponsor: Sunnybrook Health Sciences Centre

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 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 .

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aprepitant and Granisetron	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 Palliative radiation therapy.
Aprepitant and Granisetron	Palliative radiation therapy	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 Palliative radiation therapy.
Aprepitant and Granisetron	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 Palliative radiation therapy.

Primary Outcome Measures

Name	Time	Method
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).	Days 2-10 following radiotherapy	Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.

Secondary Outcome Measures

Name	Time	Method
Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy	Days 2-10 following radiotherapy	Percentage of participants in the single fraction arm experiencing no nausea, vomiting, and retching was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting 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 .	From day of radiotherapy to 10 days following radiotherapy	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.
Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy	Day of radiotherapy and 24 hours following	Percentage of participants experiencing no nausea, vomiting, and retching during the acute phase was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily following the radiation therapy based on patient self-report nausea/vomiting diaries.
Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy	During radiotherapy (5 days) and the 24 hours following radiotherapy	Percentage of participants in the multiple fraction arm experiencing no nausea, vomiting, and retching was assessed. 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.
Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy	Days 2-10 following radiotherapy	Percentage of participants experiencing no nausea, vomiting, and retching was assessed. Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.