This is a single-site, open-label, randomized pilot feasibility study conducted at The Ottawa Hospital Cancer Centre. A total of 10 participants will be randomized 1:1 to either the experimental or control arm. The purpose of this study is to evaluate recruitment capability, intervention adherence, data completeness, and safety prior to consideration of a potential future multi-centre randomized trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
10
300mg/0.5mg combination pill taken once daily by mouth on the first and third day of chemotherapy
8mg taken twice daily by mouth for 5 days
Daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Feasibility of study
To measure the feasibility of the study, the researchers will collect the recruitment rate, the consent rate among eligible patients, the completion of symptom and quality-of-life assessments, the adherence to protocol, the frequency of protocol deviations and safety events.
Time frame: Through study completion, up to 1 year
Complete Response (CR)
To evaluate the CR after Cycle 1
Time frame: After Cycle 1 (Each cycle is 7 days)
Early Complete Response, late Complete Response and total control
To evaluate the response at the end of the study
Time frame: 1 year
Review toxicities
Describe patient-reported toxicities using PRO-CTCAE
Time frame: 1 year
Quality of Life outcomes
Describe the quality of life outcomes using the Functional Living Index Emesis (FLIE)
Time frame: 1 year
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Daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days)
5mg taken at night by mouth for 7 days