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

9 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies how well dietary and exercise interventions work in reducing side effects in patients with stage I-IIIa breast cancer taking aromatase inhibitors. Anti-inflammatory Mediterranean dietary and bone strengthening exercise interventions may alleviate medication side effects such as joint and bone pain and protectively influence bone mineral density, improve heart functioning, and reduce risk of breast cancer recurrence in breast cancer patients taking aromatase inhibitors.

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.

What data supports the effectiveness of the treatment for breast cancer side effects?

Research suggests that diet and exercise interventions can help reduce the risk of breast cancer recurrence and improve body composition in survivors. Additionally, these lifestyle changes may enhance quality of life, sleep quality, and reduce anxiety among breast cancer survivors. ^{1 2 3 4 5}

Is diet and exercise safe for managing breast cancer side effects?

Research shows that exercise and dietary interventions are generally safe for breast cancer survivors, helping improve body composition, muscular strength, and quality of life without significant safety concerns. ^{2 6 7 8 9}

How does the diet and exercise treatment for breast cancer side effects differ from other treatments?

This treatment is unique because it combines impact-aerobic and strength exercises with dietary habits to improve body composition and reduce fat tissue in breast cancer survivors treated with aromatase inhibitors. Unlike standard drug treatments, it focuses on lifestyle changes to manage side effects and improve overall health. ^{1 7 10 11 12}

Research Team

Catherine L. Carpenter, PhD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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.

I am taking medication for bone loss.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of lifestyle modification after breast cancer treatment: a systematic review protocol. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized trial of exercise and diet on body composition in survivors of breast cancer with overweight or obesity. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

[Interventions to improve healthy lifestyles and their effects on psychological variables among breast cancer survivors: a systematic review]. [2018]

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

Nutrition education intervention for women with breast cancer: effect on nutritional factors and oxidative stress. [2015]

5. 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]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Combining Impact-Aerobic and Strength Exercise, and Dietary Habits on Body Composition in Breast Cancer Survivors Treated with Aromatase Inhibitors. [2023]

8. United States 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. [2023]

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

Effects of exercise interventions during different treatments in breast cancer. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Supportive Care in Oncology-From Physical Activity to Nutrition. [2022]

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

Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial. [2023]

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

Analysis of the relationship between diet and exercise beliefs and actual behaviors among breast cancer survivors in northwest ohio. [2022]