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

Fred Hutchinson Cancer Center (FHCC)

Status: Enrolling

Conditions: Advanced Melanoma; Melanoma (Skin); Skin Cancer

Treatments: Behavioral: Exercise Program; Behavioral: Diet Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06298734

20845 (Other Identifier)

NCI-2024-02279 (Other Identifier)

RG1125274

Details and patient eligibility

About

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)

Full description

This single-center, four-arm, pilot randomized research study is to test if high-intensity exercise and high-fiber diet are feasible and effective in improving the gut microbiome health, immune function, physical fitness, treatment-related side effects, and treatment outcomes in participants with advanced melanoma receiving immunotherapy. Participants will be randomized into 1 of 4 study groups: Group A Exercise, Group B Diet, Group C Combined, and Group D Attention Control. Randomization means a participant will be placed into an intervention group by chance.

The information learned by doing this research may help determine whether participating in such lifestyle interventions are tolerable during immunotherapy and exert health benefits among melanoma participants.

The research study procedures include screening for eligibility, study visits, stool samples, blood tests, and questionnaires.

Participation in this study is expected to last up to a total of 9 weeks.

It is expected about 40 people will take part in this research study.

This study is sponsored by the World Cancer Research Fund International and American Association for Cancer Research.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Group A: High-Intensity Exercise (EX)

Experimental group

Description:

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

Treatment:

Behavioral: Exercise Program

Group B: High-Fiber Diet (DT)

Experimental group

Description:

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:

Behavioral: Diet Program

Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB)

Experimental group

Description:

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:

Behavioral: Diet Program

Behavioral: Exercise Program

Group D: Attention Control (AC)

No Intervention group

Description:

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