Clinical trial NCT06298734: High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Official title: Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma (Skin)
Skin Cancer
Advanced Melanoma
Keywords: Melanoma
Skin Cancer
Advanced Melanoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: World Cancer Research Fund International
First posted: 2024-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

Detailed description: This single-center, four-arm, pilot randomized research study is to test if high-intensity exercise and high-fiber diet are feasible and effective in improving the gut microbiome health, immune function, physical fitness, treatment-related side effects, and treatment outcomes in participants with advanced melanoma receiving immunotherapy. Participants will be randomized into 1 of 4 study groups: Group A Exercise, Group B Diet, Group C Combined, and Group D Attention Control. Randomization means a participant will be placed into an intervention group by chance.

The information learned by doing this research may help determine whether participating in such lifestyle interventions are tolerable during immunotherapy and exert health benefits among melanoma participants.

The research study procedures include screening for eligibility, study visits, stool samples, blood tests, and questionnaires.

Participation in this study is expected to last up to a total of 9 weeks.

It is expected about 40 people will take part in this research study.

This study is sponsored by the World Cancer Research Fund International.

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.

Primary outcomes:
measure: Change in Gut Microbiome Diversity
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
Secondary outcomes:
measure: Change in Systemic Immune Function
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Cardiopulmonary Fitness
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Percent Body Fat
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Lean mass
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Hip circumference
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Waist circumference
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Health-Related Quality of life (EORTC-QLQ C30)
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in MDASI-Immunotherapy Questionnaire Score
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Anxiety (HADS)
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Depression (HADS)
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Change in Sleep Quality (PSQI)
timeFrame: Baseline (Week 1) and post-intervention (Week 10)
measure: Proportion of Participants Completing the Exercise Intervention Sessions
timeFrame: Post-intervention (Week 10)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, MD
role: PRINCIPAL_INVESTIGATOR
References: