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Behavioural Intervention
Group A: High-Intensity Exercise (EX) for Skin Cancer
N/A
Waitlist Available
Led By Dong-Woo Kang, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 1) and post-intervention (week 10)
Awards & highlights
Study Summary
"This trial aims to find out if doing intense exercise and following a high-fiber diet can be done and help improve the health of people with advanced melanoma who are getting immunotherapy. The study will
Who is the study for?
This trial is for individuals with advanced melanoma who are currently receiving immunotherapy. Participants should be able to perform high-intensity exercise and follow a high-fiber diet.Check my eligibility
What is being tested?
The study tests the effects of high-intensity exercise, a high-fiber diet, and their combination on health outcomes in melanoma patients under immunotherapy compared to an attention control group.See study design
What are the potential side effects?
While not drug-related, potential side effects may include muscle soreness or injury from exercise and gastrointestinal discomfort from dietary changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 1) and post-intervention (week 10)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 1) and post-intervention (week 10)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Gut Microbiome Diversity
Secondary outcome measures
Change in Anxiety (HADS)
Change in Cardiopulmonary Fitness
Change in Depression (HADS)
+10 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB)Experimental Treatment2 Interventions
10 participants will complete:
In-office baseline visit.
Virtual exercise sessions 3x weekly.
1x weekly appointment with research staff via Zoom platform to review to review diet adherence. Diet appointment may be combined with exercise session appointment.
Post-intervention in-office visit.
Group II: Group B: High-Fiber Diet (DT)Experimental Treatment1 Intervention
10 participants will complete:
In-office baseline visit.
1x weekly appointment with research staff to review to review diet adherence.
Post-intervention in-office visit.
Group III: Group A: High-Intensity Exercise (EX)Experimental Treatment1 Intervention
10 participants will complete:
In-office baseline visit.
Virtual exercise sessions 3x weekly.
Post-intervention in-office visit.
Group IV: Group D: Attention Control (AC)Active Control1 Intervention
10 participants will complete:
In-office baseline visit.
Participants will receive a general healthy lifestyle guidebook.
Pot-intervention in-office visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Program
2016
Completed Phase 3
~4930
Find a Location
Who is running the clinical trial?
World Cancer Research Fund InternationalOTHER
6 Previous Clinical Trials
96,658 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
341,193 Total Patients Enrolled
Dong-Woo Kang, PhDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
68 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being actively recruited for participation in this study?
"As per the details on clinicaltrials.gov, this particular research endeavor is no longer in need of participants. Despite its closure for recruitment, there are currently 770 alternative trials actively seeking eligible candidates."
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