Recruiting

High-Intensity Exercise & High-Fiber Diet

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT06298734

Conditions

Melanoma (Skin)

Skin Cancer

Advanced Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Program

Diet Program

Study Details

Brief summary:

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)

Conditions

Melanoma (Skin)

Skin Cancer

Advanced Melanoma

Study ID

NCT06298734

Start date

Jul 1, 2024

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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).
  • Patients who are non-English speaking and cannot complete the participant surveys.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Exercise Program

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Dong-Woo Kang, PhD

206-667-5188dkang@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Dong-Woo Kang, PhD

206-667-5188dkang@fredhutch.org

Principal Investigator:

Dong-Woo Kang, PhD

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Melanoma
  • Skin Cancer
  • Advanced Melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-08-19.