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Completed

NCT Number: NCT02388750

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Palonosetron

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

Radiation

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

Primary outcomes

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

    Time frame: Day 0 to Day 10 post-radiation

    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.

Secondary outcomes

  1. Complete prophylaxis of nausea

    Time frame: Day 0 to Day 10 post-radiation

    Proportion of patients achieving complete prophylaxis of nausea and not requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy

  2. Complete prophylaxis of vomiting

    Time frame: Day 0 to Day 10 post-radiation

    Proportion of patients achieving complete prophylaxis of vomiting without requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy

  3. Partial control of nausea

    Time frame: Day 0 to Day 10 post-radiation

    Proportion of patients achieving partial control of nausea during and in the 10 days following radiation therapy

  4. Partial control of vomiting

    Time frame: Day 0 to Day 10 post-radiation

    Proportion of patients achieving partial control of vomiting during and in the 10 days following radiation therapy

  5. Time to use of rescue medication

    Time frame: Day 0 to Day 10 post-radiation

    Median time from first fraction of radiation therapy to first use or increase in use of rescue medication

  6. Time to nausea

    Time frame: Day 0 to Day 10 post-radiation

    Median time from first fraction of radiation therapy to first episode or increase in episodes of nausea

  7. Time to vomiting

    Time frame: Day 0 to Day 10 post-radiation

    Median time from first fraction of radiation therapy to first episode or increase in episodes of vomiting

  8. Quality of life

    Time frame: Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation.

    Quality of life as measured by the EORTC QLQ-C15-PAL and the FLIE.

  9. Adverse effects

    Time frame: Day 0 to Day 10 post-radiation

    The side effects of constipation and headache will be monitored throughout the study period graded according to the CTCAE criteria.

Sponsors and collaborators

Lead sponsor

Dr. Edward Chow

Other

Registry information

Official study title

Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2015
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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