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

Trial Summary

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.

What data supports the effectiveness of the treatment Exercise and Diet Interventions, High-Intensity Exercise and High-Fiber Diet Intervention, Exercise and Diet Therapy for Immunotherapy Outcomes in skin cancer?

Research shows that exercise and diet interventions can improve quality of life and reduce fatigue in cancer patients, including those with advanced melanoma. Additionally, similar interventions in breast cancer patients have led to weight loss and improved health markers, suggesting potential benefits for skin cancer patients as well. ^{1 2 3 4 5}

Is the combination of exercise and diet safe for humans, particularly in cancer patients?

Research indicates that exercise and diet interventions are generally safe for cancer patients, with studies showing no adverse events reported in trials involving physical activity programs for advanced melanoma patients. These interventions are well-tolerated and can improve quality of life and reduce fatigue. ^{2 4 6 7 8}

How does the Exercise and Diet Interventions treatment for skin cancer differ from other treatments?

This treatment is unique because it combines high-intensity exercise and a high-fiber diet to potentially improve outcomes for skin cancer patients, focusing on lifestyle changes rather than traditional medical treatments. Research suggests that exercise can stimulate the body's natural processes to fight cancer, and a low-fat diet may reduce the risk of developing skin cancer, making this approach novel compared to standard treatments. ^{9 10 11 12 13}

What is the purpose of 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)

Research Team

Christina Dieli-Conwright, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

I am currently on immunotherapy for at least one month and plan to continue for 8 more weeks.

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

Exclusion Criteria

I am currently receiving treatment for advanced melanoma.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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 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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Clinical review of physical activity and functional considerations in head and neck cancer patients. [2021]

2. 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]

3. United States 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. [2021]

4. 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]

5. United States 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. [2007]

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

Exercise Behaviors and Fatigue in Patients Receiving Immunotherapy for Advanced Melanoma: A Cross-Sectional Survey via Social Media. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

High-intensity exercise interventions in cancer survivors: a systematic review exploring the impact on health outcomes. [2022]

8. United States 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. [2023]

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

Low-fat diet and skin cancer risk: the women's health initiative randomized controlled dietary modification trial. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Evidence that a low-fat diet reduces the occurrence of non-melanoma skin cancer. [2019]

12. United States 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. [2018]

13. England pubmed.ncbi.nlm.nih.gov

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