High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Program
BehavioralA 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.
Diet Program
BehavioralA virtual dietary consultation program supervised by trained research staff. Appointments will be conducted via the Zoom platform. Participants will receive an education handout at the baseline visit.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Group A: High-Intensity Exercise (EX)Experimental treatment 1 intervention
Group B: Group B: High-Fiber Diet (DT)Experimental treatment 1 intervention
Group C: Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB)Experimental treatment 2 interventions
Group D: Group D: Attention Control (AC)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion of Participants Completing the Intervention Sessions
The primary outcome is feasibility and will be assessed by the proportion of participants completing the intervention sessions with \>70% completion considered feasible.
Time frame
Post-intervention (Week 10)Secondary outcomes
1
Change in Gut Microbiome Diversity
Gut microbiome diversity is measured by the Shannon Diversity Index. Alpha diversity of samples will be quantified using the Shannon diversity index, and beta diversity will be quantified using the Bray-Curtis dissimilarity.
Time frame
Baseline (Week 1) and post-intervention (Week 10)2
Change in Systemic Immune Function
Immune phenotyping will be conducted using the blood samples drawn at baseline and post-intervention. Immunofluorescence will be performed using a flow cytometry, which analyzes the physical and fluorescent properties of cells in suspension in real-time as they flow through the instrument.
Time frame
Baseline (Week 1) and post-intervention (Week 10)3
Change in Cardiopulmonary Fitness
Cardiorespiratory fitness will be assessed as VO2peak by a graded maximal cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 15-second interval during the test.
Time frame
Baseline (Week 1) and post-intervention (Week 10)4
Change in Short Physical Performance Battery (SPPB)
Physical function will be assessed by the SPPB. This includes the following 3 lower extremity measures completed in the following order. Timed balance (seconds): Balance will be assessed under 3 conditions (side-by-side, semi-tandem, and tandem stands). Gait speed (seconds): Gait speed will be assessed over a 4-meter flat surface distance. The participant will be asked to complete 2 attempts of this test. Time will be recorded using an electronic timing system. Chair stand (seconds): Chair stand will be performed under 2 conditions: a) subjects will perform a single chair stand; b) subjects will be asked to perform 5 repeated chair stands as quickly as possible; time to completion will be recorded.
Time frame
Baseline (Week 1) and post-intervention (Week 10)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fred Hutchinson Cancer Center
Lead sponsor
World Cancer Research Fund International
Collaborator
American Association for Cancer Research
Collaborator
Source ClinicalTrials.gov