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

Study Overview
=================
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 .

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

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: Aprepitant
* Radiation: Palliative radiation therapy
* Drug: Granisetron


Participation Criteria
=================
Eligibility 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aprepitant and Granisetron<br>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. | Drug: Aprepitant<br>* Patients will be given a single dose of 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.<br>Radiation: Palliative radiation therapy<br>* Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.<br>Drug: Granisetron<br>* Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Days 2-10 following radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 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. | From day of radiotherapy to 10 days following radiotherapy | 
| Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy | 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. | Day of radiotherapy and 24 hours following | 
| Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction 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. | Days 2-10 following radiotherapy | 
| Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction 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. | During radiotherapy (5 days) and the 24 hours following radiotherapy | 
| Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction 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. | Days 2-10 following radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nausea, vomiting, antiemetics, radiotherapy, Radiation-induced nausea and vomiting