This research is studying the preventative use of topical 0.1% tazarotene gel daily in addition to best practice standards to reduce the development of hand-foot skin reaction (HFSR).
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved tazarotene for specifically for hand-foot skin reaction but it has been approved for other uses. In this research study, the investigators are: -aiming to determine if the use of tazarotene gel daily, in addition to best practice standards: * reduces the development of HFSR. * decreases modification of regorafenib dose due to HFSR * improves health-related quality of life associated with HFSR * decreases stress associated with HFSR
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin
A substance that has no therapeutic effect, used as a control in testing new drugs
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Grade 2 or Higher Hand-Foot Skin Reaction (HFSR) Rate
Grade 2 or higher hand-foot skin reaction (HFSR) Rate defined as the percentage of patients in each arm who develop grade-2 or higher HFSR within the first 8 weeks of protocol therapy. Measured via examination by a Dermatology Provider and grading according to CTCAE version 5.
Time frame: Up to 8 weeks
All Grade Hand-Foot Skin Reaction (HFSR) Rate
Any grade hand-foot skin reaction (HFSR) Rate defined as the percentage of patients in each arm who develop HFSR within the first 8 weeks of protocol therapy. Measured via examination by a Dermatology Provider and grading according to CTCAE version 5.
Time frame: Up to 8 weeks
Change in HFS-14 Score From Baseline to Day 56
HFS-14 is a specific quality of life scale developed for patients suffering from Hand-Foot Syndrome. It involves 14 questions per protocol Appendix D. Answers are ranked based on the subscripts listed from the level that affect quality of life much to less. Answers are ranked based on the subscripts from survey to not affect life quality (1-4). Maximum score is 44, and minimum score is 14. Change measured from baseline and day 56. Higher score means worse situation.
Time frame: At baseline and at day 56.
Change in Perceived Stress Scale (PSS) From Baseline to Day 56
PSS is a classic stress assessment instrument that helping understand how different situations affect patients' feelings and perceived stress. Patients answer 10 questions defined in protocol appendix D. Answers are ranked 0-4. The higher the overall scores indicate higher perceived stress. Score range is from 0 to 40. Higher score means more stressful. Change measured at baseline and day 56.
Time frame: at baseline and day 56
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