Melanoma (Skin)NCT06298734
High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
A study testing Exercise Program and Diet Program in people with Melanoma (Skin) and Skin Cancer, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Skin Cancer, Advanced Melanoma
- What is being tested?
- Exercise Program and Diet Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- Patients who are non-English speaking and cannot complete the participant surveys.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Dong-Woo Kang, PhD, 206-667-5188, dkang@fredhutch.org
Dong-Woo Kang, PhD
About this study
Official title: Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO 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)
Read the 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 and American Association for Cancer Research.
- Conditions
- Melanoma (Skin), Skin Cancer, Advanced Melanoma
- Being tested
- Exercise Program, Diet Program
- Keywords
- Melanoma, Skin Cancer, Advanced Melanoma
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
A 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 ProgramBehavioural
A 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: High-Intensity Exercise (EX) | Experimental | 10 participants will complete:
* In-office baseline visit.
* Virtual exercise sessions 3x weekly.
* Post-intervention in-office visit. Receives: Behavioral: Exercise Program |
| Group B: High-Fiber Diet (DT) | Experimental | 10 participants will complete:
* In-office baseline visit.
* 1x weekly appointment with research staff to review to review diet adherence.
* Post-intervention in-office visit. Receives: Behavioral: Diet Program |
| Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB) | Experimental | 10 participants will complete:
* In-office baseline visit.
* Virtual exercise sessions 3x weekly.
* 1x weekly appointment with research staff via Zoom platform to review to review diet adherence. Diet appointment may be combined with exercise session appointment.
* Post-intervention in-office visit. Receives: Behavioral: Exercise Program; Behavioral: Diet Program |
| Group D: Attention Control (AC) | No intervention | 10 participants will complete: * In-office baseline visit. * Participants will receive a general healthy lifestyle guidebook. * Pot-intervention in-office visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention (Week 10)
Secondary outcomes (13)
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.
Measured: Baseline (Week 1) and post-intervention (Week 10)
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.
Measured: Baseline (Week 1) and post-intervention (Week 10)
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.
Measured: Baseline (Week 1) and post-intervention (Week 10)
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.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Percent Body Fat
Percent body fat will be assessed via bioelectrical impedance using a validated device (Tanita 780, Arlington Heights, IL). Participants will be asked to remove their shoes and socks and stand still on the device while holding the handles with their hands at their sides. The device will estimate body fat using an algorithm based on age, sex, height, and body weight.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Lean mass
Lean mass (kg) will be assessed via bioelectrical impedance using a validated device (Tanita 780, Arlington Heights, IL). Participants will be asked to remove their shoes and socks and stand still on the device while holding the handles with their hands at their sides. The device will estimate body fat using an algorithm based on age, sex, height, and body weight.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Hip circumference
A constant-tension tape measure will be used to obtain waist circumference (i.e., the distance around the waist using the umbilicus as the reference point) (cm).
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Waist circumference
A constant-tension tape measure will be used to obtain hip circumference (the distance around the widest girth of the buttocks using the greater trochanter as a landmark) (cm).
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Health-Related Quality of life (EORTC-QLQ C30)
The European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire-C30 will assess health-related quality of life, consisting of subscales including functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures. The score ranges from 0 to 100 and a higher value indicates a better quality of life.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in MDASI-Immunotherapy Questionnaire Score
MD Anderson Symptom Inventory-Immunotherapy (MDASI-Immunotherapy EPT) module is comprised of 20 symptoms including 7 immunotherapy-specific items in addition to the 13 MDASI core symptoms.The MDASI asks participants to rate the severity of disease-related and treatment-related symptoms during the past 24 h. Each symptom (pain, fatigue, nausea, disturbed sleep, emotional distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling, rash, diarrhea, pain the abdomen, swelling in the hands and legs, headache, night sweats and fever and/or chills) is rated on an 11-point scale ranging from 0 (not present) to 10 (as bad as you can imagine). The MDASI-Immunotherapy EPT has been shown to be valid and reliable.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Anxiety (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-question instrument that measures anxiety and depression with seven questions for each. Each question is scored between zero (no impairment) and three (severe impairment), with a maximum score of 21 for anxiety.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Depression (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-question instrument that measures anxiety and depression with seven questions for each. Each question is scored between zero (no impairment) and three (severe impairment), with a maximum score of 21 for depression.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Sleep Quality (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The seven components are then summed to obtain a global score ranging from 0-21 points.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Jul 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- World Cancer Research Fund International, American Association for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Dong-Woo Kang, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298734
- Sponsor's protocol ID
- RG1125274
- Other IDs
- 20845, NCI-2024-02279
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
- ClinicalTrials.gov ID
- NCT06298734
- Acronym / sponsor ID
- RG1125274
- Conditions
- Melanoma (Skin), Skin Cancer, Advanced Melanoma
- Keywords
- Melanoma, Skin Cancer, Advanced Melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- World Cancer Research Fund International, American Association for Cancer Research
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and American Association for Cancer Research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: High-Intensity Exercise (EX) | Experimental | Behavioral: Exercise Program10 participants will complete: * In-office baseline visit. * Virtual exercise sessions 3x weekly. * Post-intervention in-office visit. |
| Group B: High-Fiber Diet (DT) | Experimental | Behavioral: Diet Program10 participants will complete: * In-office baseline visit. * 1x weekly appointment with research staff to review to review diet adherence. * Post-intervention in-office visit. |
| Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB) | Experimental | Behavioral: Exercise Program, Behavioral: Diet Program10 participants will complete: * In-office baseline visit. * Virtual exercise sessions 3x weekly. * 1x weekly appointment with research staff via Zoom platform to review to review diet adherence. Diet appointment may be combined with exercise session appointment. * Post-intervention in-office visit. |
| Group D: Attention Control (AC) | No intervention | –10 participants will complete: * In-office baseline visit. * Participants will receive a general healthy lifestyle guidebook. * Pot-intervention in-office visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
- Patients who are non-English speaking and cannot complete the participant surveys.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramA 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. | Behavioural | Group A: High-Intensity Exercise (EX), Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB) |
| Diet ProgramA 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. | Behavioural | Group B: High-Fiber Diet (DT), Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB) |
Primary outcome
Proportion of Participants Completing the Intervention Sessions
Time frame: Post-intervention (Week 10)
The primary outcome is feasibility and will be assessed by the proportion of participants completing the intervention sessions with >70% completion considered feasible.
13 secondary outcomes
Change in Gut Microbiome Diversity
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Systemic Immune Function
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Cardiopulmonary Fitness
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Short Physical Performance Battery (SPPB)
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Percent Body Fat
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Lean mass
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Hip circumference
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Waist circumference
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Health-Related Quality of life (EORTC-QLQ C30)
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in MDASI-Immunotherapy Questionnaire Score
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Anxiety (HADS)
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Depression (HADS)
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Sleep Quality (PSQI)
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Melanoma (Skin)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong-Woo Kang, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program and Diet Program in people with Melanoma (Skin) and Skin Cancer, run by Fred Hutchinson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Woo Kang, PhD (206-667-5188, dkang@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Completing the Intervention Sessions (time frame: Post-intervention (Week 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.