Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
NCT Number: NCT02388750
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
Toronto, Ontario, M4N3M5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT
Low or moderately emetogenic radiotherapy will be given to all patients on study.
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.
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
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
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
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
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
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
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
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.
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.
Dr. Edward Chow
Other
Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study
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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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