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

Dr. Edward Chow

Status and phase: Completed; Phase 2

Conditions: Vomiting; Nausea

Treatments: Drug: Palonosetron; Radiation: Low or moderate risk radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02388750

Palonosetron

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

No previous nausea and vomiting

Other group

Description:

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

Treatment:

Drug: Palonosetron

Radiation: Low or moderate risk radiotherapy

Previous nausea and/or vomiting

Other group

Description:

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

Treatment:

Drug: Palonosetron

Radiation: Low or moderate risk radiotherapy