Exercise + Diet for Skin Cancer

Overseen By Christina Dieli-Conwright, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Immune checkpoint inhibitors

Must not be taking: Chemotherapy, Targeted therapy

Disqualifiers: Exercise, Fiber intake, Unstable comorbidities, others

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a high-intensity exercise program and a high-fiber diet can improve health outcomes for people with advanced melanoma receiving immunotherapy. Participants are divided into four groups: one doing exercise, one following a high-fiber diet, one doing both, and one receiving general lifestyle advice. Individuals with advanced melanoma who are on immune therapy and not currently very active or eating a high-fiber diet might be suitable candidates. The goal is to assess the feasibility and benefits of these lifestyle changes during treatment. As an unphased trial, this study provides a unique opportunity to explore lifestyle changes that could enhance the treatment experience.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, you cannot be on other tumor-directed treatments like chemotherapy or targeted therapy while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high-intensity exercise is generally safe for cancer patients. Studies have found it to be well-tolerated, with few side effects. This type of exercise, known as HIIT (High-Intensity Interval Training), may even offer more benefits than moderate exercise for many patients.

Regarding diet, research suggests that a high-fiber diet can help people with skin cancer. Some studies have shown that patients who consume more fiber respond better to treatments and experience longer periods without their cancer worsening.

When combined, high-intensity exercise and a high-fiber diet appear promising in cancer care. They may boost the immune system and enhance the effectiveness of cancer treatments.

Various studies have tested these lifestyle changes, and they are generally considered safe. However, starting slowly and consulting healthcare providers before making any changes is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine lifestyle changes to potentially benefit skin cancer patients in innovative ways. Unlike standard treatments that focus on surgery, radiation, or chemotherapy, these interventions explore how high-intensity exercise and high-fiber diets might impact health outcomes. The study includes three unique approaches: high-intensity exercise, high-fiber diet, and a combination of both, providing insights into how these lifestyle modifications might complement or enhance current skin cancer care. By targeting overall health and wellness rather than just the cancer itself, these treatments could offer additional benefits, such as improved quality of life and better management of the condition.

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

This trial will evaluate the effects of high-intensity exercise and a high-fiber diet on skin cancer outcomes. Studies have shown that high-intensity exercise can benefit people with melanoma by strengthening immune cells that fight cancer and potentially reducing tumor size. Participants in Group A will focus on high-intensity exercise. Research indicates that adding just 5 grams of fiber to the diet can lower the risk of melanoma worsening by 30%, as this type of diet helps the body respond better to cancer treatments. Participants in Group B will focus on a high-fiber diet. Group C will combine both high-intensity exercise and a high-fiber diet, which might enhance these benefits further, supporting the immune system and improving overall health. ^{1 2 3 4 5}

Who Is on the Research Team?

Christina Dieli-Conwright, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals with advanced melanoma who are currently receiving immunotherapy. Participants should be able to perform high-intensity exercise and follow a high-fiber diet.

Inclusion Criteria

I have been diagnosed with advanced melanoma.

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

Exclusion Criteria

Participating in more than 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month

Consuming more than 25 and 38 grams of dietary fiber per day for women and men, respectively over the past month

I am currently receiving treatment for advanced melanoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Intervention

Participants engage in high-intensity exercise, high-fiber diet, or both, depending on group assignment

9 weeks

Weekly virtual and in-person visits

Follow-up

Participants are monitored for changes in health outcomes post-intervention

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise and Diet Interventions

Trial Overview The study tests the effects of high-intensity exercise, a high-fiber diet, and their combination on health outcomes in melanoma patients under immunotherapy compared to an attention control group.

How Is the Trial Designed?

Group I: Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB) Experimental Treatment 2 Interventions

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.

Group II: Group B: High-Fiber Diet (DT) Experimental Treatment 1 Intervention

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.

Group III: Group A: High-Intensity Exercise (EX) Experimental Treatment 1 Intervention

10 participants will complete: * In-office baseline visit. * Virtual exercise sessions 3x weekly. * Post-intervention in-office visit.

Group IV: Group D: Attention Control (AC) Active Control 1 Intervention

10 participants will complete: * In-office baseline visit. * Participants will receive a general healthy lifestyle guidebook. * Pot-intervention in-office visit.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

World Cancer Research Fund International

Collaborator

Trials

8

Recruited

96,800+

Published Research Related to This Trial

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]

Exercise and nutrition can significantly improve lean muscle mass, functional well-being, and overall quality of life in patients with head and neck cancer, although most research has focused on other cancer types.

This review highlights the need for more targeted studies on exercise and nutrition specifically for head and neck cancer patients, as they face unique challenges that may affect their treatment and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review of physical activity and functional considerations in head and neck cancer patients. Hunter, KU., Jolly, S.[2021]

In an 8-week pilot study involving 10 sedentary, overweight breast cancer patients, participants showed significant improvements in body composition, including an average weight loss of 2.6 pounds and reductions in waist and hip circumference.

The intervention, which included thrice-weekly monitored aerobic exercise and a low-fat diet, demonstrated that breast cancer patients are motivated to adhere to such programs, leading to positive changes in health metrics despite only slight changes in hormone levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anthropometric and hormone effects of an eight-week exercise-diet intervention in breast cancer patients: results of a pilot study. McTiernan, A., Ulrich, C., Kumai, C., et al.[2007]

Voluntary running wheel exercise in mice not only reduced body fat but also increased apoptosis (cell death) in skin cells exposed to UVB light, suggesting a protective effect against skin cancer.

The study indicates that fat cells may release substances that prevent apoptosis in damaged cells, and reducing fat through exercise or diet could lower the risk of cancer by promoting cell death in potentially harmful cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulatory effect of voluntary exercise or fat removal (partial lipectomy) on apoptosis in the skin of UVB light-irradiated mice. Lu, YP., Lou, YR., Nolan, B., et al.[2018]

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 randomized trial involving 173 women with stage I-III breast cancer found that a home-based exercise and nutrition intervention improved diet quality and exercise levels but did not significantly affect the relative dose intensity (RDI) of chemotherapy compared to usual care.

However, the intervention was associated with a higher rate of pathologic complete response (pCR) in women receiving neoadjuvant chemotherapy, with 53% of those in the intervention group achieving pCR compared to 28% in the usual care group, indicating potential benefits for certain breast cancer subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study. Sanft, T., Harrigan, M., McGowan, C., et al.[2023]

A 2-year clinical trial with 115 skin cancer patients showed that switching to a low-fat diet (20% of total caloric intake) significantly reduced the occurrence of actinic keratosis (AK) and non-melanoma skin cancer (NMSC), with patients in the diet intervention group experiencing only 3.2 new AK per patient compared to 11.6 in the control group.

The diet intervention group also saw a significant decline in NMSC occurrences in the last 8 months of the study, suggesting that dietary modifications can be an effective strategy for preventing skin cancer even after UV exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of dietary factors on actinically-induced skin cancer. Black, HS.[2019]

In a 2-year study involving 101 skin-cancer patients, those on a low-fat diet (20% of caloric intake from fat) showed a significant reduction in the occurrence of non-melanoma skin cancer compared to a control group consuming 38% of calories from fat.

The decline in skin cancer occurrences in the low-fat diet group became statistically significant in the last 8-month period of the study, indicating that dietary changes can have a meaningful impact on cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence that a low-fat diet reduces the occurrence of non-melanoma skin cancer. Black, HS., Thornby, JI., Wolf, JE., et al.[2019]

In a large study involving 48,835 postmenopausal women over 8.1 years, a low-fat dietary pattern did not significantly reduce the incidence of nonmelanoma skin cancer (NMSC) or melanoma overall.

However, the results indicated that women with higher baseline fat intake experienced an increased risk of melanoma with the low-fat diet, while those with lower baseline fat intake showed a potential reduction in melanoma risk, suggesting that individual dietary history may influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-fat diet and skin cancer risk: the women's health initiative randomized controlled dietary modification trial. Gamba, CS., Stefanick, ML., Shikany, JM., et al.[2022]

High-intensity exercise interventions significantly improved health outcomes such as cardiovascular fitness (VO2 max), strength, and body composition in cancer survivors, based on a systematic review of nine studies involving 531 participants.

The risk of adverse events during supervised high-intensity exercise was low, making it a safe and effective option for cancer survivors looking to enhance their physical health in a time-efficient manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity exercise interventions in cancer survivors: a systematic review exploring the impact on health outcomes. Toohey, K., Pumpa, K., McKune, A., et al.[2022]

A lifestyle intervention involving diet and physical activity led to significant weight loss (5.6 kg) and improvements in body composition among 37 overweight and obese breast cancer survivors who completed the program.

Participants showed substantial reductions in energy and fat intake, along with improvements in quality of life and cardiorespiratory fitness, indicating the intervention's effectiveness in promoting healthier lifestyles post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. Travier, N., Fonseca-Nunes, A., Javierre, C., et al.[2021]

A survey of 55 melanoma patients undergoing immunotherapy revealed that over half (56%) engaged in exercise, primarily walking, to help reduce treatment-related fatigue.

Patients reported various physical and emotional benefits from exercise, particularly in alleviating fatigue, but also faced barriers such as fatigue itself and other physical demands, highlighting the need for tailored exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Behaviors and Fatigue in Patients Receiving Immunotherapy for Advanced Melanoma: A Cross-Sectional Survey via Social Media. Hyatt, A., Drosdowsky, A., Williams, N., et al.[2020]

Increased caloric intake and body weight are linked to a higher risk of various cancers, with total caloric intake being more critical than dietary fat percentage in tumor development, as shown in both animal and human studies.

Omega-3 fatty acids and regular exercise have protective effects against cancer, with exercise not only reducing tumor formation but also improving overall mortality rates and lowering cancer risk in specific populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional cancer risks derived from energy and fat. Simopoulos, AP.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06298734

Study Details | NCT06298734 | High-Intensity Exercise and ... The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among ...

2. wcrf.org wcrf.org/research-policy/our-research/grants-database/how-high-intensity-exercise-and-fibre-affect-immunotherapy-outcomes-for-patients-with-melanoma/

How high-intensity exercise and fibre affect immunotherapy ... This trial will explore the effects of a high-fibre diet and high-intensity exercise on the gut microbiome, immune function and immunotherapy outcomes in ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2024-02279

High-Intensity Exercise and High-Fiber Diet to Improve ... This clinical trial tests whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among individuals with ...

4. dana-farber.org dana-farber.org/clinical-trials/23-712

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 ...

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

Diet and Immune Effects Trial (DIET) Study 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.