Diet and Exercise for Melanoma

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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for melanoma?

Research suggests that exercise can improve immune function and potentially enhance the body's response to melanoma treatment. Additionally, lifestyle factors like diet and exercise may impact melanoma development and progression, indicating that these interventions could be beneficial. ^{1 2 3 4 5}

Is diet and exercise generally safe for humans in clinical trials?

Research suggests that exercise is generally safe and may even reduce the risk of melanoma, as seen in studies where people who exercised regularly had a lower risk of developing melanoma. Additionally, a trial is assessing the safety of a personalized exercise program for melanoma patients, indicating ongoing evaluation of its safety. ^{1 2 3 6 7}

How does the diet and exercise treatment for melanoma differ from other treatments?

This treatment is unique because it focuses on lifestyle changes, specifically diet and exercise, to potentially reduce melanoma risk and improve quality of life, rather than relying on traditional medical interventions like drugs or surgery. Exercise has been shown to decrease melanoma risk and improve quality of life in patients, while certain dietary factors may influence melanoma development. ^{6 7 8 9 10}

What is the purpose of this trial?

Background: The gut microbiome is made up microorganisms. These include the good and bad bacteria that live in the digestive tract. Changes in the gut microbiome have been linked to the development of cancer. Researchers want to learn more about the effects of modulating the microbiome with diet and exercise. Objective: To see if nutritional intake and physical activity change the gut microbiome in people with melanoma. Eligibility: Adults age 18 and older with previously untreated melanoma who will be getting immunotherapy treatment for their disease. Design: Participants will not have visits at NIH. They will have phone calls or videocalls. Participants will be screened with a medical history and medical record review. Participants will give stool samples. They will fill out surveys about their health, feelings, diet, and exercise. Participants will be put in 1 of 2 groups. They will follow their group s plan for 4 months. They will be contacted throughout the study. Intervention Group participants will follow a plant-based, high-fiber diet. They will do at least 150 minutes of moderate or 75 minutes of high-intensity exercise per week. They will have sessions with psychology staff to help them make positive lifestyle changes. Control Group participants will be taught healthy eating and exercise guidelines. But they will not be asked to change their diet or exercise habits. All participants will record what they eat in the MyFitnessPal app. They will get a scale to measure their weight each week. They will wear a Garmin(R) physical activity tracker at all times. They can take the tracker off to bathe or shower. Participation will last for 6 months....

Research Team

James L Gulley, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Moderate physical exercise improves lymphocyte function in melanoma-bearing mice on a high-fat diet. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Impact of body composition on outcomes from anti-PD1 +/- anti-CTLA-4 treatment in melanoma. [2021]

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

i-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Melanoma risk in relation to height, weight, and exercise (United States). [2022]

8. England pubmed.ncbi.nlm.nih.gov

Description of supportive care and feasibility of physical exercise program to improve quality of life in advanced melanoma patients. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Diet and melanoma. An exploratory case-control study. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

An Epidemiological Review of Diet and Cutaneous Malignant Melanoma. [2023]