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

Not Applicable

Recruiting

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

• Registration Number: NCT06298734
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-1
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Age =18 years; due to the rarity of the disease in those <18 years, this age bracket<br> will not be included.<br><br> - Histologically diagnosed with advanced melanoma.<br><br> - Having been or newly receiving immune checkpoint inhibitor, including anti-PD1,<br> antiCTLA4, and/or anti-LAG3 monoclonal antibodies, with palliative intent for at<br> least one month with a plan to continue immunotherapy for at least 8 weeks (i.e.,<br> study intervention period) at the time of recruitment.<br><br> - Not receiving other concurrent tumor-directed systemic treatment (e.g., chemotherapy<br> or targeted therapy).<br><br> - Medically cleared to participate in high-intensity exercise and high-fiber diet by<br> their treating oncologist.<br><br> - Not having medical conditions that could exacerbate with exercise, such as bone<br> disease at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic<br> diseases (e.g., uncontrolled hypertension or diabetes).<br><br> - Currently not meeting the physical activity guideline (i.e., more than 150 minutes<br> per week of moderate-to-vigorous intensity, regular, structured aerobic exercise)<br> over the past month at the time of recruitment.<br><br> - Currently not meeting the daily dietary fiber intake guideline (i.e., 30 grams/day)<br> over the past month at the time of recruitment.<br><br> - Ability to communicate and complete written forms in English.<br><br> - Ability to understand and the willingness to sign informed consent prior to any<br> study- related procedures.<br><br> - Willing to travel to DFCI for necessary data collection.<br><br>Exclusion Criteria:<br><br> - Receiving other concurrent systemic treatment for advanced melanoma such as<br> chemotherapy or targeted therapy. This study is to exclusively target patients<br> receiving immune checkpoint inhibitors where other treatments may impact the study<br> outcomes of intervention efficacies and feasibilities.<br><br> - Participating in more than 150 minutes of moderate-to-vigorous aerobic exercise per<br> week over the past month. This study targets insufficiently active persons to assess<br> the effect of the described exercise intervention, where additional exercise done<br> regularly will contaminate the intervention outcomes.<br><br> - Consuming more than 25 and 38 grams of dietary fiber per day for women and men,<br> respectively over the past month. This study targets persons who insufficiently take<br> dietary fiber to assess the effect of the described dietary intervention, where<br> additional dietary fiber intake will contaminate the intervention outcomes.<br><br> - Having unstable comorbidities or medical conditions that prevent participation in<br> high intensity exercise or high-fiber diet interventions. Patients with unstable<br> medical conditions may develop unexpected adverse events from exercise and dietary<br> changes. For the purpose of patients' safety, patients with unstable medical<br> conditions are excluded.<br><br> - Subjects who in the opinion of the investigator may not be able to comply with the<br> safety monitoring requirements of the study.<br><br> - Development of second malignancy (except for basal cell carcinoma or squamous cell<br> carcinoma of the skin) that requires concurrent treatment, which would interfere<br> with this study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Gut Microbiome Diversity

Secondary Outcome Measures

Name	Time	Method
Change in Systemic Immune Function;Change in Cardiopulmonary Fitness;Change in Short Physical Performance Battery (SPPB);Change in Percent Body Fat;Change in Lean mass;Change in Hip circumference;Change in Waist circumference;Change in Health-Related Quality of life (EORTC-QLQ C30);Change in MDASI-Immunotherapy Questionnaire Score;Change in Anxiety (HADS);Change in Depression (HADS);Change in Sleep Quality (PSQI);Proportion of Participants Completing the Exercise Intervention Sessions