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

Launched by DANA-FARBER CANCER INSTITUTE · Mar 1, 2024

Keywords

ClinConnect Summary

The DUO Trial is a research study designed to see if high-intensity exercise and a high-fiber diet can help improve health outcomes for patients with advanced melanoma who are receiving a type of treatment called immunotherapy. The study will compare four groups: one group will focus on high-intensity exercise, another on a high-fiber diet, a third group will combine both approaches, and a fourth group will serve as a control with no specific intervention. Researchers hope to find out if these lifestyle changes can make immunotherapy more effective or easier to tolerate.

To be eligible for the study, participants must be at least 18 years old and have a confirmed diagnosis of advanced melanoma. They should be receiving immunotherapy treatment and not currently undergoing other cancer treatments like chemotherapy. Participants should also not have been meeting exercise or dietary guidelines in the past month, meaning they should be relatively inactive and not consuming enough fiber. Those who join the study can expect to engage in structured exercise and dietary changes for at least two months, and they will be monitored throughout to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

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