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New treatment option for Melanoma (Skin)
Official title High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
ClinicalTrials.gov ID: NCT06298734
What this study is testing
- What it's testing
- 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)
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology...
- Patients who are non-English speaking and cannot complete the participant surveys.
See the full eligibility 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.
- 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...
- 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...
- Patients who are non-English speaking and cannot complete the participant surveys.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.