Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)

NCT ID: NCT02388750

Last Updated: 2017-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-08-07

Brief Summary

This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis or rescue of single or multiple fraction radiation induced nausea and vomiting. This prospective study employs a parallel arm design, allowing for inclusion of patients with pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients receiving radiotherapy known to have a low or moderate emetogenic risk will receive every other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of rescue medication, and impact on quality of life will be monitored during and after radiation treatment completion.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

No previous nausea and vomiting

Palonosetron 0.5 mg oral capsule given for the length of radiation treatment

No previous nausea and vomiting 24 hours prior to radiotherapy

Group Type: OTHER

Palonosetron

Intervention Type: DRUG

Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT

Low or moderate risk radiotherapy

Intervention Type: RADIATION

Low or moderately emetogenic radiotherapy will be given to all patients on study.

Previous nausea and/or vomiting

Palonosetron 0.5 mg oral capsule given for the length of radiation treatment

Previous nausea and/or vomiting 24 hours prior to radiotherapy

Group Type: OTHER

Palonosetron

Intervention Type: DRUG

Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT

Low or moderate risk radiotherapy

Intervention Type: RADIATION

Low or moderately emetogenic radiotherapy will be given to all patients on study.

Interventions

Palonosetron

Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT

Intervention Type: DRUG

Low or moderate risk radiotherapy

Low or moderately emetogenic radiotherapy will be given to all patients on study.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Informed consent
• Patient will receive radiation therapy to considered moderate risk (upper abdomen, upper and half body irradiation) or low risk (lower thorax and pelvis) emetogenic palliative radiotherapy.
• Patients will be grouped according to nausea and vomiting status at baseline as follows:

• Group 1: Patient is experiencing no nausea and vomiting at baseline
• Group 2: Patient is experiencing at least mild nausea and/or at least mild vomiting at baseline

Exclusion Criteria

• Patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol RT.
• Patient received cranial RT within 7 days prior to commencement of protocol RT.
• Patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol RT.
• Patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol RT.
• Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties within 48 hours prior to protocol RT.
• Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties during or within 10 days following completion of protocol RT.
• Concurrent use of corticosteroids during protocol RT is not permitted, unless low dose corticosteroids (hydrocortisone) are used for cancer treatment
• Patient is allergic to protocol medication.
• Patient has a Karnofsky Performance Status score <40.
• Patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Edward Chow

OTHER

Sponsor Role: lead

Responsible Party

Dr. Edward Chow

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chow Edward, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Locations

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Palonosetron

Identifier Type: -

Identifier Source: org_study_id