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

NCT02388750 | Completed Phase 2 DMC

• 1 other identifier: Palonosetron
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

nausea; vomiting; radiation; anti-emetic drug

Outcome Measures

Primary Outcomes (1)

• Efficacy for prevention of nausea and vomiting events as measured by a daily diary

  Primary outcome is to determine the efficacy of palonosetron for the prevention of radiation-induced vomiting in patients undergoing low or moderate emetogenic radiation therapy. Daily diary collects events of nausea and/or vomiting, and corresponding severity.

  Day 0 to Day 10 post-radiation

Secondary Outcomes (9)

• Complete prophylaxis of nausea

  Day 0 to Day 10 post-radiation

• Complete prophylaxis of vomiting

  Day 0 to Day 10 post-radiation

• Partial control of nausea

  Day 0 to Day 10 post-radiation

• Partial control of vomiting

  Day 0 to Day 10 post-radiation

• Time to use of rescue medication

  Day 0 to Day 10 post-radiation

Study Arms (2)

No previous nausea and vomiting

OTHER

Palonosetron 0.5 mg oral capsule given for the length of radiation treatment No previous nausea and vomiting 24 hours prior to radiotherapy

Drug: Palonosetron; Radiation: Low or moderate risk radiotherapy

Previous nausea and/or vomiting

OTHER

Palonosetron 0.5 mg oral capsule given for the length of radiation treatment Previous nausea and/or vomiting 24 hours prior to radiotherapy

Drug: Palonosetron; Radiation: Low or moderate risk radiotherapy

Interventions

Palonosetron DRUG

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

No previous nausea and vomiting; Previous nausea and/or vomiting

Low or moderate risk radiotherapy RADIATION

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

No previous nausea and vomiting; Previous nausea and/or vomiting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Edward Chow: lead

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chow Edward, MBBS PhD

  Odette Cancer Centre, Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 17, 2015
• Study Start: April 1, 2015
• Primary Completion: August 7, 2017
• Study Completion: August 7, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

CA (1)