High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT06298734
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise Program — BEHAVIORAL
    A high-intensity interval training, aerobic exercise program virtually supervised, home-based, and appointment-based program under direct one-on-one supervision by a trained oncology exercise specialist. Sessions will be conducted via the Zoom platform. Participants will be provided with home stationary bike, heart rate monitor, blood pressure monitor. For participants who do not have a smart device, a Wi-Fi enabled tablet will be provided.
  • Diet Program — BEHAVIORAL
    A virtual dietary consultation program supervised by trained research staff. Appointments will be conducted via the Zoom platform. Participants will receive an education handout at the baseline visit.

Study Details

The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy. The names of the groups in this research study are: * High-Intensity Exercise (EX) * High-fiber Diet (DT) * Combined High-Intensity Exercise and High-Fiber Diet (COMB) * Attention Control (AC)

Key Dates

Start date
Jul 1, 2024
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Group A: High-Intensity Exercise (EX)
    10 participants will complete: * In-office baseline visit. * Virtual exercise sessions 3x weekly. * Post-intervention in-office visit.
  • Experimental: Group B: High-Fiber Diet (DT)
    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.
  • Experimental: Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB)
    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.
  • No Intervention: Group D: Attention Control (AC)
    10 participants will complete: * In-office baseline visit. * Participants will receive a general healthy lifestyle guidebook. * Pot-intervention in-office visit.

Primary Outcome Measure

Proportion of Participants Completing the Intervention Sessions [ Time Frame: Post-intervention (Week 10) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Christina Dieli-Conwright, PhD
[email protected]
617-582-8321
Christina Dieli-Conwright, PhD (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Dong-Woo Kang, PhD
[email protected]
206-667-5188
Dong-Woo Kang, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Dana-Farber Cancer Institute· Boston, MAFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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