9 Participants Needed

Diet and Exercise for Breast Cancer Side Effects

GT
Overseen ByGail Thames
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Jonsson Comprehensive Cancer Center
Must be taking: Aromatase inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.26789

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.17101112

Research Team

CL

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.
See 5 more

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.
See 6 more

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
2Treatment groups
Experimental Treatment
Group I: Arm II (exercise intervention)Experimental Treatment2 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 Treatment2 Interventions
Patients receive a controlled anti-inflammatory diet over 12 weeks.

Find a Clinic Near You

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.
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.
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.
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]

References

Effects of lifestyle modification after breast cancer treatment: a systematic review protocol. [2022]
A randomized trial of exercise and diet on body composition in survivors of breast cancer with overweight or obesity. [2022]
[Interventions to improve healthy lifestyles and their effects on psychological variables among breast cancer survivors: a systematic review]. [2018]
Nutrition education intervention for women with breast cancer: effect on nutritional factors and oxidative stress. [2015]
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]
Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial. [2023]
Effect of Combining Impact-Aerobic and Strength Exercise, and Dietary Habits on Body Composition in Breast Cancer Survivors Treated with Aromatase Inhibitors. [2023]
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]
Effects of exercise interventions during different treatments in breast cancer. [2018]
Supportive Care in Oncology-From Physical Activity to Nutrition. [2022]
11.United Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
Analysis of the relationship between diet and exercise beliefs and actual behaviors among breast cancer survivors in northwest ohio. [2022]
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