NCT06298734

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jul 2024Mar 2027

First Submitted

Initial submission to the registry

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

March 1, 2024

Last Update Submit

March 26, 2026

Conditions

Melanoma (Skin)Skin CancerAdvanced Melanoma

Keywords

MelanomaSkin CancerAdvanced Melanoma

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants Completing the Intervention Sessions

    The primary outcome is feasibility and will be assessed by the proportion of participants completing the intervention sessions with \>70% completion considered feasible.

    Post-intervention (Week 10)

Secondary Outcomes (13)

  • Change in Gut Microbiome Diversity

    Baseline (Week 1) and post-intervention (Week 10)

  • Change in Systemic Immune Function

    Baseline (Week 1) and post-intervention (Week 10)

  • Change in Cardiopulmonary Fitness

    Baseline (Week 1) and post-intervention (Week 10)

  • Change in Short Physical Performance Battery (SPPB)

    Baseline (Week 1) and post-intervention (Week 10)

  • Change in Percent Body Fat

    Baseline (Week 1) and post-intervention (Week 10)

  • +8 more secondary outcomes

Study Arms (4)

Group A: High-Intensity Exercise (EX)

EXPERIMENTAL

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

Behavioral: Exercise Program

Group B: High-Fiber Diet (DT)

EXPERIMENTAL

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.

Behavioral: Diet Program

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

EXPERIMENTAL

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.

Behavioral: Exercise ProgramBehavioral: Diet Program

Group D: Attention Control (AC)

NO INTERVENTION

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

Interventions

Exercise ProgramBEHAVIORAL

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.

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

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

MelanomaSkin Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dong-Woo Kang, PhD

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Woo Kang, PhD

CONTACT

206-667-5188dkang@fredhutch.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)