Diet and Exercise for Melanoma

Not currently recruiting at 1 trial location

Overseen By James L Gulley, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Must be taking: Immunotherapy

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Pregnancy, Smoking, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how diet and exercise might affect gut bacteria in individuals with melanoma, a type of skin cancer. Researchers aim to determine if a plant-based, high-fiber diet combined with regular exercise can alter the gut microbiome, which has been linked to cancer development, in participants undergoing immunotherapy. Participants will be divided into two groups: one will follow a specific diet and exercise plan (Intervention Arm), while the other will receive general health guidelines without specific changes (Control). This study suits adults with untreated melanoma who are about to start immunotherapy and are willing to track their diet and activity using a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on lifestyle changes and cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are using certain supplements or have used systemic antibiotics in the past 30 days.

What prior data suggests that this diet and exercise protocol is safe for people with melanoma?

Research shows that diet and exercise are safe for people with melanoma, even during immunotherapy. Studies have found that a plant-based, high-fiber diet is easy for melanoma patients to follow without issues. Another study discovered that physical exercise did not negatively affect the quality of life for these patients. In fact, a telehealth exercise program proved to be safe and practical.

Therefore, prospective participants in this trial can be assured that changing diet and exercise routines should be safe and manageable during treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how diet and exercise might influence melanoma outcomes. Unlike traditional treatments like surgery, immunotherapy, or targeted therapy, this approach focuses on lifestyle changes. The trial could reveal if these non-invasive methods can complement existing treatments, potentially leading to better, more holistic care strategies for melanoma patients. This could offer a new dimension to treatment that empowers patients with more control over their health.

What evidence suggests that this trial's treatments could be effective for melanoma?

This trial will compare a lifestyle modification intervention, including diet and exercise changes, with a control group receiving standard care. Research has shown that exercise and diet changes might help manage melanoma. Some studies suggest that physical activity is linked to a lower risk of developing melanoma. A high-fiber diet could positively affect the gut, which plays a role in cancer development. Early studies in melanoma patients indicated that a fiber-rich diet might improve outcomes. While more research is needed to confirm these benefits, these findings offer hope that lifestyle changes might support melanoma treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

James L Gulley, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Adults over 18 with untreated melanoma starting immunotherapy can join. They must be able to follow diet and exercise plans, use specific apps, wear a fitness tracker, complete surveys, and provide stool samples. Excluded are those on other trials or treatments, heavy drinkers, drug users, pregnant women, smokers or recent quitters.

Inclusion Criteria

I can care for myself but may not be able to do active work.

Willingness and capability to comply with diet and exercise prescriptions, use the MyFitnessPal app, wear the Garmin (trademark) device, complete surveys, and provide stool samples. Participants must own a smartphone capable of running the MyFitnessPal and Garmin Connect (trademark) apps.

My melanoma has not been treated with any systemic therapy in the last 30 days.

Exclusion Criteria

You are currently using illegal drugs.

I am currently receiving treatment for another cancer.

Medical contraindications to the study diet and/or exercise prescriptions as determined by a physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

No in-person visits, phone or videocalls

Treatment

Participants follow a diet and exercise plan for 4 months, with stool sample collections and health surveys

16 weeks

Remote monitoring with phone or videocalls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Intervention Arm

Trial Overview The EDEN trial is testing how a plant-based diet and regular exercise affect the gut microbiome in melanoma patients receiving immunotherapy. One group will change their lifestyle significantly while the control group won't alter their habits but will receive healthy guidelines.

How Is the Trial Designed?

Group I: 2 Experimental Treatment 1 Intervention

Control- Standard diet and Exercise

Group II: 1 Experimental Treatment 2 Interventions

Intervention

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 287 melanoma patients treated with immune checkpoint inhibitors, body composition measures like total adipose tissue index (TATI) and skeletal muscle gauge (SMG) were found to correlate with clinical outcomes, with high TATI linked to poorer progression-free survival (PFS).

Patients with intermediate TATI and high SMG had the best outcomes, while those with low SMG and high TATI experienced worse PFS and overall survival (OS), highlighting the importance of body composition over body mass index in predicting treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of body composition on outcomes from anti-PD1 +/- anti-CTLA-4 treatment in melanoma. Young, AC., Quach, HT., Song, H., et al.[2021]

Epidemiological studies suggest that dietary factors, such as caffeine, may lower the risk of developing cutaneous malignant melanoma, while citrus fruits and alcohol are linked to an increased risk.

The review highlights the potential mechanisms by which diet influences melanoma development, including enhancing UV-induced cell death and altering photosensitivity, indicating that dietary modifications could play a role in public health strategies to reduce melanoma incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Epidemiological Review of Diet and Cutaneous Malignant Melanoma. Yang, K., Fung, TT., Nan, H.[2023]

Mice on a high-fat diet showed increased body weight and tumor growth rates in melanoma, but moderate physical exercise significantly reduced tumor progression, suggesting exercise can counteract some negative effects of obesity.

The study found that exercise improved lymphocyte function, enhancing their proliferation while decreasing the T-helper 1 response, indicating that physical activity may help modulate immune responses in the context of melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate physical exercise improves lymphocyte function in melanoma-bearing mice on a high-fat diet. Dos Santos, CMM., Diniz, VLS., Bachi, ALL., et al.[2022]

A study involving 271 patients with advanced melanoma found that about 60% were interested in supportive care, indicating a strong demand for interventions like Adapted Physical Activity (APA) to help manage cancer-related fatigue.

The supervised APA program was deemed safe and well-tolerated, with good participant retention and no reported adverse events, suggesting that physical activity could be a beneficial supportive care option for improving quality of life in advanced melanoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of supportive care and feasibility of physical exercise program to improve quality of life in advanced melanoma patients. Boileau, M., Templier, C., Massip, E., et al.[2023]

Obesity may actually improve outcomes for melanoma patients receiving immune and targeted therapies, potentially due to the hormone leptin influencing these effects.

The gut microbiome is emerging as a key factor in predicting responses to immunotherapy, with diet and exercise potentially modulating its impact on immunity and melanoma progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifiable Host Factors in Melanoma: Emerging Evidence for Obesity, Diet, Exercise, and the Microbiome. Warner, AB., McQuade, JL.[2020]

A systematic review of six studies involving 882 melanoma patients found that physical activity or exercise did not lead to significant improvements in quality of life, fatigue, physical function, or other health-related outcomes.

Importantly, engaging in physical activity during melanoma treatment or survivorship did not have any negative effects on patients, suggesting it is safe for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of Physical Activity and Exercise with Health-related Outcomes in Patients with Melanoma During and After Treatment: A Systematic Review. Crosby, BJ., Lopez, P., Galvão, DA., et al.[2021]

Aerobic exercise, specifically treadmill running, has been shown to improve tumor blood vessel formation and enhance immune cell infiltration in melanoma tumors in a mouse model.

The study suggests that these benefits are mediated through an ERK5-dependent mechanism, highlighting the potential of exercise as a modifiable factor to boost responses to immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as an Immune Boost: Mechanism-Driven Support for Lifestyle Interventions. Betof Warner, A.[2023]

This pilot study will assess the safety and acceptability of a 12-week personalized exercise program for 30 patients with stage IV melanoma undergoing immunotherapy, aiming to counteract treatment-related fatigue.

The trial will provide preliminary evidence on the efficacy of exercise in improving fatigue and quality of life, with follow-up assessments planned over 24 weeks to measure various patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

i-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol. Hyatt, A., Gough, K., Murnane, A., et al.[2021]

In a study of 386 melanoma patients and 727 controls, men in the highest quartiles of height, weight, and body surface area showed a significantly increased risk of melanoma, with odds ratios ranging from 2.4 to 2.8 compared to those in the lowest quartiles.

Regular exercise (five to seven days per week) was associated with a decreased risk of melanoma for both men and women, suggesting a potential protective effect that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melanoma risk in relation to height, weight, and exercise (United States). Shors, AR., Solomon, C., McTiernan, A., et al.[2022]

A study of 41 women with melanoma compared to 297 controls found that high intakes of polyunsaturated fatty acids were strongly associated with a reduced risk of melanoma, suggesting a potential protective effect.

Women consuming 20 grams or more of alcohol daily had a significantly increased risk of melanoma, with an odds ratio of 2.5, indicating that alcohol consumption may be a risk factor for this type of skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and melanoma. An exploratory case-control study. Bain, C., Green, A., Siskind, V., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10751671/

Impact of Physical Exercise on Melanoma Hallmarks Several cohort studies and meta-analyses reported a positive association between physical activity/exercise and melanoma risk.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11619607/

a randomized, double-blinded dietary intervention study in ... Fecal microbiota transplant studies have shown positive signals of improved outcomes in both ICB-naïve and refractory melanoma patients; however ...

3. mdpi.com mdpi.com/2072-6643/17/11/1891

The Influence of Dietary Factors on Melanoma ... Dietary modifications have been associated with a reduced risk of other malignancies, such as colorectal and breast cancer. However, evidence linking diet to ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.9511

A randomized controlled phase 2 trial of a high fiber diet ... Clinical outcomes of the DIET study: A randomized controlled phase 2 trial of a high fiber diet intervention (HFDI) in patients with melanoma ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03950635

Dietary Intervention in Patients with a History of Melanoma We will examine the effects of a whole-food, fiber-rich diet on the gut microbiome within patients with a history of melanoma. Ketogenic diet rationale: The ...

6. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13234-1

Diet and Immune Effects Trial (DIET)- a randomized, double ... This is a randomized, double-blind, fully controlled feeding study that will enroll 45 melanoma patients starting standard-of-care (SOC) ICB in three settings.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.9558

The DIET study: A randomized controlled trial of a high ... Conclusions: In this fully-controlled feeding study among melanoma pts undergoing ICB tx, both arms of the intervention were well-tolerated. In ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8381455/

Associations of Physical Activity and Exercise with Health ... Physical activity or exercise did not adversely impact quality of life, objectively-measured or patient-reported outcomes in patients with melanoma.