Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial

New trial explores exercise and diet to boost immunotherapy for melanoma patients.

NCT: NCT06298734 · Status: RECRUITING · Phase: N/A · Sponsor: Fred Hutchinson Cancer Center · Started: 2024-07-01 · Est. Completion: 2027-03-31

Plain English Summary

High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial is a Not Applicable clinical trial sponsored by Fred Hutchinson Cancer Center studying Melanoma (Skin), Skin Cancer, Advanced Melanoma. This study tests if high-intensity exercise and a high-fiber diet can improve health outcomes for advanced melanoma patients receiving immunotherapy. It is for adults diagnosed with melanoma who are currently receiving or will soon start immunotherapy. Participants will be assigned to one of four groups: high-intensity exercise, high-fiber diet, a combination of both, or a control group. Alternative options include standard immunotherapy treatment without these lifestyle interventions. The trial aims to enroll 40 participants.

Official 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)

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have been diagnosed with melanoma, and are receiving or planning to continue immunotherapy for at least 8 weeks. You must be able to perform physical fitness tests (ECOG 0-2) and understand the study. You cannot join if you already exercise vigorously for 150+ minutes weekly or eat 30+ grams of fiber daily. Individuals with unstable or uncontrolled chronic medical conditions that make exercise risky, or those likely to miss appointments, may not be eligible. This trial is studying Melanoma (Skin), Skin Cancer, Advanced Melanoma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how many participants successfully complete the exercise and diet programs, indicating if these interventions are manageable for patients. The specific primary outcome measures are: Proportion of Participants Completing the Intervention Sessions (Post-intervention (Week 10)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a gap in cancer care by investigating lifestyle interventions like exercise and diet to potentially enhance the effectiveness of immunotherapy for melanoma. This research targets Melanoma (Skin), Skin Cancer, Advanced Melanoma, where improved treatment options are needed.

Investor Insight

This trial signals a growing interest in non-pharmacological approaches to improve cancer treatment outcomes, potentially expanding the market for supportive care interventions in oncology.

Is This Trial Right for Me?

Ask your doctor if this trial is right for you, especially regarding your current health and ability to exercise. Participation involves being assigned to a group and following its specific exercise and/or diet plan for about 10 weeks, with virtual supervision and support. You may receive equipment like a stationary bike and heart rate monitor for the exercise group. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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 Locations

Frequently Asked Questions

What is clinical trial NCT06298734?

NCT06298734 is a Not Applicable INTERVENTIONAL study titled "High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial." It is currently recruiting and is sponsored by Fred Hutchinson Cancer Center. The trial targets enrollment of 40 participants.

What conditions does NCT06298734 study?

This trial investigates treatments for Melanoma (Skin), Skin Cancer, Advanced Melanoma. The primary condition under study is Melanoma (Skin).

What treatments are being tested in NCT06298734?

The interventions being studied include: Exercise Program (BEHAVIORAL), Diet 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.

What does Not Applicable mean for NCT06298734?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06298734?

This trial is currently "Recruiting." It started on 2024-07-01. The estimated completion date is 2027-03-31.

Who is sponsoring NCT06298734?

NCT06298734 is sponsored by Fred Hutchinson Cancer Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06298734?

The trial aims to enroll 40 participants. The trial is currently recruiting and accepting new participants.

How is NCT06298734 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06298734?

The primary outcome measures are: Proportion of Participants Completing the Intervention Sessions (Post-intervention (Week 10)). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06298734 being conducted?

This trial is being conducted at 2 sites, including Boston, Massachusetts; Seattle, Washington (United States).

Where can I find official information about NCT06298734?

The official record for NCT06298734 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06298734. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06298734 testing in simple terms?

This study tests if high-intensity exercise and a high-fiber diet can improve health outcomes for advanced melanoma patients receiving immunotherapy. It is for adults diagnosed with melanoma who are currently receiving or will soon start immunotherapy.

Why is this trial significant?

This trial addresses a gap in cancer care by investigating lifestyle interventions like exercise and diet to potentially enhance the effectiveness of immunotherapy for melanoma.

What are the potential risks of participating in NCT06298734?

Potential risks include muscle soreness, fatigue, or injury from exercise, especially if you have pre-existing conditions. Dietary changes might cause temporary digestive discomfort. There's a risk of not responding as expected to the interventions or experiencing side effects from your immunotherapy. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06298734?

Ask your doctor if this trial is right for you, especially regarding your current health and ability to exercise. Participation involves being assigned to a group and following its specific exercise and/or diet plan for about 10 weeks, with virtual supervision and support. You may receive equipment like a stationary bike and heart rate monitor for the exercise group. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06298734 signal from an investment perspective?

This trial signals a growing interest in non-pharmacological approaches to improve cancer treatment outcomes, potentially expanding the market for supportive care interventions in oncology. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will be assigned to one of four groups: high-intensity exercise, high-fiber diet, a combination of both, or a control group. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.