Diet and Exercise Intervention for Breast Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Pregnancy, Stroke, Heart failure, Dementia, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 11

Duration: 7 months

173 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the diet and exercise intervention safe for breast cancer patients?

The studies suggest that diet and exercise interventions are generally safe for breast cancer survivors, as they focus on improving diet quality and increasing physical activity, which are beneficial for overall health. ^{1 2 3 4 5}

How does the Dietary/Physical Activity intervention treatment differ from other treatments for breast cancer?

This treatment is unique because it focuses on lifestyle changes, specifically a low-calorie diet and regular physical activity, to promote weight loss and improve health outcomes in breast cancer survivors, rather than using medication or surgery. It aims to improve prognosis by addressing obesity, a known negative factor in breast cancer survival, through sustainable lifestyle modifications. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Dietary/Physical Activity intervention for breast cancer?

Research shows that a diet and physical activity program can help breast cancer survivors lose weight and improve their quality of life. Participants in a study lost an average of 5.6 kg and reported better overall health after the intervention. ^{1 6 10 11 12}

Who Is on the Research Team?

Tara Sanft, M.D.

Principal Investigator

Yale University

Melinda Irwin, Ph.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for English-speaking women recently diagnosed with Stage I-III breast cancer who are about to start chemotherapy. They must be able to walk and follow the study's guidelines. Women can't join if they're pregnant, planning pregnancy, have had a stroke or heart failure in the past year, already follow similar health guidelines, or have completed their second chemo session.

Inclusion Criteria

Able to complete forms, understand instructions and read intervention book in English

I am scheduled for chemotherapy before or after surgery.

I agree to be randomly placed in a treatment or standard care group.

Exclusion Criteria

I follow recommended diet and exercise guidelines.

I have not had a stroke, heart attack, or severe heart failure in the past year.

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant or adjuvant chemotherapy along with dietary and physical activity intervention

7 months

11 counseling sessions over 6 months, additional 5 sessions in latter 6 months

Follow-up

Participants are monitored for adherence to treatment, changes in biomarkers, body composition, diet, physical activity, and quality of life

5 years

Long-term Follow-up

Assessment of long-term outcomes such as quality of life and physical activity

5 years post-diagnosis

What Are the Treatments Tested in This Trial?

Interventions

• Dietary/Physical Activity intervention
• Usual Care

Trial Overview The study compares two approaches: one group will receive guidance on diet and exercise after their diagnosis (intervention), while the other will continue with their usual care without additional advice (control). The goal is to see how these strategies affect treatment adherence, body composition, and biomarkers.

How Is the Trial Designed?

Group I: Dietary/Physical Activity Intervention Experimental Treatment 1 Intervention

Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program).

Group II: Usual Care Group Active Control 1 Intervention

Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant). Lifestyle intervention books for breast cancer survivors at the end of the study. Women will also be offered a counselling session with a registered study dietician at the end of the study.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The simultaneous stage-matched exercise and diet (SSED) intervention was found to be feasible and well-accepted among 45 breast cancer survivors, with 91% completing the trial and 100% receiving intervention calls.

Participants in the SSED group showed significant improvements in motivational readiness for exercise and diet, as well as better emotional functioning, reduced fatigue, and lower depression compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. Kim, SH., Shin, MS., Lee, HS., et al.[2022]

The NExT program, which included supervised exercise and healthy eating for women undergoing chemotherapy for breast cancer, was safe and effective, with 78% of participants completing the program and significant increases in moderate-to-vigorous physical activity (MVPA) during and after treatment.

Participants experienced lasting improvements in health-related quality of life (HRQoL) one year after the program, indicating that the exercise and nutrition intervention had a sustained positive impact on their well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Oncologist-Referred Exercise and Healthy Eating Programming as a Part of Supportive Adjuvant Care for Early Breast Cancer. Kirkham, AA., Van Patten, CL., Gelmon, KA., et al.[2019]

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]

The LEAN study showed that a 6-month lifestyle intervention for overweight or obese breast cancer survivors significantly improved diet quality, with the intervention group increasing their Healthy Eating Index (HEI) score by 6.8 points compared to 3.1 points in the usual care group.

Participants in the intervention group also achieved greater reductions in total and saturated fat intake, along with increases in fiber and fruit consumption, indicating that weight loss interventions can positively impact dietary habits in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in diet quality in a randomized weight loss trial in breast cancer survivors: the lifestyle, exercise, and nutrition (LEAN) study. Anderson, C., Harrigan, M., George, SM., 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]

Physical activity is linked to a lower risk of developing breast cancer and recurrence, as well as improved survival rates, based on observational studies.

Engaging in physical activity can alleviate treatment-related side effects, such as fatigue from chemotherapy and musculoskeletal issues from aromatase inhibitors, highlighting its importance in breast cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. Peterson, LL., Ligibel, JA.[2019]

A study of 368 women with breast cancer revealed that most participants made significant dietary changes towards healthier options, such as reducing high-fat and high-sugar foods while increasing fish, fruits, vegetables, and whole grains.

Despite positive dietary changes, only 22.6% of women increased their physical activity, which is important for improving health and potentially reducing the risk of breast cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and physical activity in relation to weight change among breast cancer patients. Yaw, YH., Shariff, ZM., Kandiah, M., et al.[2019]

Citations

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

Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of Oncologist-Referred Exercise and Healthy Eating Programming as a Part of Supportive Adjuvant Care for Early Breast Cancer. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Nutrition and physical activity influence on breast cancer incidence and outcome. [2022]

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Postdiagnosis diet quality, the combination of diet quality and recreational physical activity, and prognosis after early-stage breast cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Physical activity during and after adjuvant chemotherapy in patients with breast cancer. [2013]

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

Changes in diet quality in a randomized weight loss trial in breast cancer survivors: the lifestyle, exercise, and nutrition (LEAN) study. [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

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. [2019]

10. Thailand pubmed.ncbi.nlm.nih.gov

Diet and physical activity in relation to weight change among breast cancer patients. [2019]

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

Can lifestyle modification increase survival in women diagnosed with breast cancer? [2018]

12. England pubmed.ncbi.nlm.nih.gov

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