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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Takeda Canada, Inc.
Information provided by (Responsible Party):
Dr. Edward Chow, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02006056
First received: November 28, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Nausea
Vomiting
Drug: Ondissolve
Radiation: Palliative Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Study of Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting - a Phase II Study

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Proportion of patients with complete prophylaxis and partial control [ Time Frame: Day 0 - Day 10 ] [ Designated as safety issue: No ]
    Primary endpoint of the study will be to determine efficacy of the medication for the prevention/rescue of radiation induced nausea and vomiting in patients undergoing emetogenic radiation therapy for the treatment of bone metastases as measured by the proportion of patients with complete prophylaxis and partial control


Secondary Outcome Measures:
  • Complete prophylaxis of nausea and/or vomiting [ Time Frame: During and 10 days following radiotherapy ] [ Designated as safety issue: No ]
    Proportion of patients achieving complete prophylaxis of nause and/or vomiting and not requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy

  • Partial control of nausea and vomiting [ Time Frame: During and 10 days following radiotherapy ] [ Designated as safety issue: No ]
    Proportion of patients achieving partial control of nausea and vomiting during and in the 10 days following radiation therapy

  • Time to nausea, vomiting and/or use of rescue medication [ Time Frame: During and 10 days following radiotherapy ] [ Designated as safety issue: No ]
    Median time from first fraction of radiation therapy to first episode or increase in episodes of vomiting, first episode or increase in episodes of nausea, and/or first use or increase in rescue medication.


Other Outcome Measures:
  • Quality of Life by the EORTC QLQ-C15-PAL [ Time Frame: Baseline, day 5 and 10 during treatment and post treatment ] [ Designated as safety issue: No ]
    Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable.

  • Quality of Life by the FLIE [ Time Frame: Baseline, day 5 and 10 during treatment, day 3 and 7 post treatment ] [ Designated as safety issue: No ]
    Quality of life as measured by the FLIE. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable.


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ondissolve
Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.
Drug: Ondissolve
Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.
Radiation: Palliative Radiation Therapy
Patient will receive palliative radiation therapy considered emetogenic for bone metastases.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006056

Contacts
Contact: Edward Chow, MBBS PhD 416-480-4998 edward.chow@sunnybrook.ca

Locations
Canada, Ontario
Odette Cancer Centre, Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Edward Chow, MBBS PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Takeda Canada, Inc.
Investigators
Principal Investigator: Edward Chow, MBBS PhD Odette Cancer Centre, Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Edward Chow, Professor, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02006056     History of Changes
Other Study ID Numbers: Ondissolve
Study First Received: November 28, 2013
Last Updated: December 4, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014