Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-03-31

Brief Summary

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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 .

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Detailed Description

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Conditions

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Nausea Vomiting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Aprepitant and 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.

Group Type EXPERIMENTAL

Aprepitant

Intervention Type DRUG

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.

Palliative radiation therapy

Intervention Type RADIATION

Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.

Granisetron

Intervention Type DRUG

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).

Interventions

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Aprepitant

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.

Intervention Type DRUG

Palliative radiation therapy

Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.

Intervention Type RADIATION

Granisetron

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).

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No