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Tests exercise and high-fiber diet with immunotherapy in advanced melanoma

Tests exercise and a high-fiber diet in adults with advanced melanoma receiving immunotherapy.

Key facts

Who runs it
Fred Hutchinson Cancer Center
Where
Boston and Seattle, United StatesSee the 2 sites
Trial code
Registry title
High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Status
Recruiting
People taking part
40 people, planned
Started
1 Jul 2024
Expected to end
31 Jul 2027
Type of study
Interventional, 4 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Exercise Program
  • Diet Program
Record updated
19 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced melanoma who are receiving immunotherapy and will test a high-intensity exercise program and a high-fiber diet.

Age
18 years or older
Sex
All sexes
Disease stage
Melanoma confirmed by tissue examination; the trial is about advanced melanoma. ECOG performance status of 0-2.
Earlier treatment
Must have been or be newly receiving immunotherapy for at least one month, with a plan to continue for at least 8 weeks.

Main reasons for not taking part

  • Already doing 150 minutes or more of moderate-to-vigorous aerobic exercise per week over the past month
  • Already eating 30 grams or more of fiber per day over the past month
  • Unstable or uncontrolled medical conditions that make exercise high-risk
  • High risk of not following the study procedures
  • Non-English speaking and cannot complete the surveys

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Age ≥18 years
  • Histologically diagnosed with melanoma
  • Having been or newly receiving immunotherapy for at least one month
  • Having a plan to continue immunotherapy for at least 8 weeks at the time of recruitment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments
  • Ability to understand and willingness to provide informed consent

Who cannot take part

  • Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture
  • Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts)
  • Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month
  • Consuming ≥ 30 grams/day of dietary fiber over the past month
  • Patients who are non-English speaking and cannot complete the participant surveys

Where in United States

  • Dana-Farber Cancer InstituteBoston, United StatesContact: Dong-Woo Kang, PhDNo longer taking part
  • Fred Hutch/University of Washington Cancer ConsortiumSeattle, United StatesContact: Dong-Woo Kang, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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)

The 4 groups in the trial

  • Group A: High-Intensity Exercise (EX)Treatment being tested

    10 participants will complete: * In-office baseline visit. * Virtual exercise sessions 3x weekly. * Post-intervention in-office visit.

    Treatment: Exercise Program

  • Group B: High-Fiber Diet (DT)Treatment being tested

    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.

    Treatment: Diet Program

  • Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB)Treatment being tested

    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.

    Treatment: Exercise Program and Diet Program

  • Group D: Attention Control (AC)No study treatment, for comparison

    10 participants will complete: * In-office baseline visit. * Participants will receive a general healthy lifestyle guidebook. * Pot-intervention in-office visit.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Plain-language title
Tests exercise and high-fiber diet with immunotherapy in advanced melanomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 August 2026