Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 2

Conditions: Vomiting; Nausea

Treatments: Drug: Ondansetron

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02006056

Ondissolve

Details and patient eligibility

About

The primary objective of the study is to examine the efficacy of Ondissolve for the prevention/rescue of Acute and Delayed Phase radiation induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. The study population will be 30 patients seen in the RRRP at the Sunnybrook Odette Cancer Centre receiving palliative radiation therapy considered emetogenic for bone metastases. Patients will take the study medication (Ondissolve 8 mg) twice on each day of radiation therapy, at least one hour prior to treatment and repeat approximately 6-8 hours later the same day. Patients undergoing multiple fraction radiation therapy will take Ondissolve on weekends or holidays in between treatment. Secondary objectives include to evaluate key secondary endpoints related to RINV, and to investigate the ease and length of administration of protocol medicine. We hypothesize that Ondissolve will be effective in the prophylaxis of RINV, and the ease of use and administration will provide an appropriate delivery method for those unable to tolerate the oral form of ondansetron.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent
• Patient will receive palliative radiation therapy considered emetogenic for bone metastases.
• Group 1: At least mild nausea and/or at least mild vomiting as recorded in the Baseline Nausea and Vomiting Data Collection Sheet
• Group 2: Nausea and vomiting recorded as 'none' in the Baseline Nausea and Vomiting Data Collection Sheet

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 corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity within 48 hours of protocol RT.
• Patient is scheduled to change regimen/dose or start the use of corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic activity during or within 10 days following completion of protocol RT.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Secondary prophylaxis

Experimental group

Description:

Patients already experiencing mild nausea/vomiting within 24 hours before radiotherapy. Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx. 608 hours later in the day (bid). For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment.

Treatment:

Drug: Ondansetron

Primary prophylaxis

Experimental group

Description:

Patients experiencing no nausea and vomiting 24 hours before commencement of radiotherapy. Intervention is 8mg of ondansetron (Ondissolve) on the day of radiation treatment at least 1 hour prior to treatment and repeated approx. 608 hours later in the day (bid). For patients who are treated with 20Gy/5 fractions, or 30Gy/10 fractions, they will take ondansetron twice (bid) on each day of treatment, at least 1 hour prior to treatment, and also on weekends or holidays in between treatment.

Treatment:

Drug: Ondansetron