Diet and Exercise for Breast Cancer Side Effects

Overseen By Gail Thames

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Must be taking: Aromatase inhibitors

Must not be taking: Bisphosphonates, Glucocorticoids

Disqualifiers: Metastatic cancer, Food allergies, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how diet and exercise might alleviate side effects from breast cancer treatment. It targets patients with stage I-IIIa breast cancer who have taken aromatase inhibitors, known to cause joint and bone pain. The trial consists of two parts: one tests a special anti-inflammatory diet (dietary intervention), and the other tests a bone-strengthening exercise program (exercise intervention). Postmenopausal individuals who have had breast cancer for at least six months and experience joint pain might be suitable candidates. As an unphased trial, this study provides a unique opportunity for patients to explore non-drug interventions that may enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you continue taking aromatase inhibitors.

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

Research shows that both diet and exercise are generally safe for breast cancer patients during treatment. Studies indicate that consuming whole grains, fruits, vegetables, and lean proteins may help lower the risk of breast cancer and reduce treatment side effects. Concerns about nutrient deficiencies or fatigue from dietary changes are usually minor and manageable with proper guidance.

Exercise is also safe and beneficial. Research suggests it can improve quality of life and lessen treatment side effects. Home-based exercise programs are particularly safe, with only minor issues reported.

Overall, evidence supports that both diet and exercise are well-tolerated by people with breast cancer, offering potential benefits with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for managing breast cancer side effects because they take a holistic approach by focusing on lifestyle changes instead of medication. Unlike standard treatments that often involve pharmaceuticals with potential side effects, the dietary intervention emphasizes an anti-inflammatory diet, which may help reduce pain and swelling naturally. Meanwhile, the exercise intervention involves structured workouts with a trainer, aiming to improve physical strength, mental health, and overall quality of life. These approaches offer a promising alternative by potentially enhancing well-being without the drawbacks of traditional drug-based therapies.

What evidence suggests that these dietary and exercise interventions could be effective for reducing side effects in breast cancer patients?

In this trial, participants will join one of two treatment arms to evaluate the impact of diet and exercise on breast cancer side effects. A previous study showed that low-fat diets helped people lose weight and lowered the risk of breast cancer recurrence. Specifically, dietary changes improved emotional and social well-being, sleep quality, and overall health for breast cancer patients. Research has shown that exercise can reduce treatment side effects and enhance the quality of life for those with breast cancer. Exercise also correlates with a lower risk of breast cancer recurrence and reduced death rates. These findings suggest that diet and exercise might help manage side effects and improve health for patients taking aromatase inhibitors for breast cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Catherine L. Carpenter, PhD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for postmenopausal women with stage I-IIIa breast cancer who are currently taking aromatase inhibitors and experiencing joint pain. They should be in good health, at least 6 months past chemotherapy or radiation, not on bone loss medication, without severe bone density issues or fractures since starting AIs, and not already engaged in regular exercise.

Inclusion Criteria

I am in good health as confirmed by recent medical exams and tests.

My breast cancer is at stage IIIa or below and has not spread widely.

I have had joint pain for at least 2 months.

Exclusion Criteria

I am currently receiving chemotherapy or radiation.

I have physical limitations that stop me from fully participating in exercise.

You have a very high body mass index (BMI).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either a controlled anti-inflammatory diet or undergo controlled exercise sessions with a dedicated trainer for 12 weeks

12 weeks

3 visits per week (in-person for exercise group)

Follow-up

Participants are monitored for changes in inflammatory markers, joint and muscle pain, and bone mineral density

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Intervention
• Exercise Intervention

Trial Overview The study is testing if a special diet (Anti-inflammatory Mediterranean) combined with bone-strengthening exercises can reduce joint pain and improve heart function and bone density in patients taking aromatase inhibitors to potentially lower the chance of cancer coming back.

How Is the Trial Designed?

Group I: Arm II (exercise intervention) Experimental Treatment 2 Interventions

Patients undergo controlled exercise sessions with a dedicated trainer 3 times a week for up to 1 hour each over 12 weeks.

Group II: Arm I (dietary intervention) Experimental Treatment 2 Interventions

Patients receive a controlled anti-inflammatory diet over 12 weeks.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Published Research Related to This Trial

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]

The ABRACE Study will evaluate the effects of different volumes of resistance training combined with aerobic exercise on physical and psychological outcomes in 84 breast cancer patients undergoing chemotherapy, aiming to clarify optimal exercise prescriptions during treatment.

The study hypothesizes that both resistance training groups (single and multiple sets) will show superior improvements in neuromuscular function and quality of life compared to a control group, potentially establishing exercise as a key management strategy for treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial. Henkin, JS., Rosa, DD., Morelle, AM., et al.[2023]

Physical activity and exercise therapy are beneficial for cancer patients during treatment and recovery, helping to manage side effects and improve overall outcomes.

Integrating nutrition therapy with physical activity into cancer treatment plans can enhance patient care and should be considered for both cancer patients and the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care in Oncology-From Physical Activity to Nutrition. Schmidt, T., Süß, P., Schulte, DM., et al.[2022]

A 12-week supervised resistance exercise program combined with home-based aerobic exercise is being tested on 60 female breast cancer survivors to see if it improves muscular strength and health-related quality of life compared to aerobic exercise alone.

The study aims to provide clear and standardized reporting of the exercise intervention, which could help improve future exercise prescriptions for breast cancer survivors dealing with treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 12-week resistance and aerobic exercise program on muscular strength and quality of life in breast cancer survivors: Study protocol for the EFICAN randomized controlled trial. Soriano-Maldonado, A., Carrera-Ruiz, Á., Díez-Fernández, DM., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11854917/

Dietary Interventions for Breast Cancer Prevention Furthermore, the women experienced significant improvements in emotional and social functioning, sleep quality, and systemic therapy side ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523303034

Dietary fat reduction and breast cancer outcome The study determined that low-fat dietary interventions can influence body weight and decrease breast cancer recurrence.

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Dietary interventions in cancer: a systematic review of all ... In this systematic review, we assessed all randomized controlled trials (RCTs) investigating dietary interventions for cancer patients.

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Effects of dietary intervention on human diseases These dietary practices could exacerbate the risk of malnutrition, sarcopenia, fatigue, delayed wound healing, and impaired immunity, ...

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Dietary interventions and tumor response to chemotherapy ... This review highlights the areas for further research to increase opportunities for nutritional-based interventions as adjuvant to chemotherapy for breast ...

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Are Dietary Supplements Safe? Some dietary supplements can cause skin sensitivity and severe reactions when taken during radiation treatment. Some supplements may react with ...

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Nutrition in Cancer Care (PDQ®) - NCI Nutrition in cancer care can be affected by the tumor or by treatment and result in weight loss, malnutrition, anorexia, cachexia, ...