Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

Study Overview
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Brief Summary
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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.

Detailed Description
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Currently the Department of Health and Human Services, the American Cancer Society and others provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines, and also elect to delay concerted efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition and breast cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast cancer prognosis. Further, by increasing our understanding of the mechanisms mediating the association between lifestyle behaviors and breast cancer survival, this study will improve our knowledge of how changes in diet and physical activity influence breast cancer outcomes. Lastly, guidelines for breast cancer survivors also overlap with those for diabetes and cardiovascular disease (CVD) prevention, the latter being a common cause of breast cancer mortality. The proposed study will examine, in 172 women newly diagnosed with Stage I-III breast cancer who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on the following breast cancer outcomes measured before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year post-diagnosis (Time 2), and at two years post-diagnosis (Time 3): adherence to treatment, and changes in biomarkers, body composition, and quality of life.

Official Title
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Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (LEANer)

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Behavioral: Dietary/Physical Activity intervention
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Stage I-III breast cancer Scheduled to receive neoadjuvant or adjuvant chemotherapy Physically able to walk Able to complete forms, understand instructions and read intervention book in English Agrees to be randomly assigned to either intervention or usual care group Exclusion Criteria: Women who have completed their 2nd chemotherapy Women already practicing dietary or physical activity guidelines Are pregnant or intending to become pregnant in the next year Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction < 40% Presence of dementia or major psychiatric disease Non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Group<br>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 2-year study. Women will also be offered a counselling session with a registered study dietician at the end of the study. | Behavioral: Usual Care<br>* Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.<br>|
| Experimental: Dietary/Physical Activity Intervention<br>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). | Behavioral: Dietary/Physical Activity intervention<br>* Motivational counseling to follow established dietary and exercise guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Treatment measured by chemotherapy completion rate | Chemotherapy completion rate will be assessed (via medical records) as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. | before initiating chemotherapy to post-chemotherapy, up to 7 months | 
| Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs) | Assessed by urinary aromatase inhibitor levels. | 12 months after enrollment | 
| Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs). | Assessed by urinary aromatase inhibitor levels. | 24 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response | In the subset of patients receiving neoadjuvant chemotherapy, no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. | At the time of surgical resection following initial course of chemotherapy | 
| Insulin level | Assessed by fasting blood (fast of 12 hours or more). | Baseline (pre-chemotherapy) | 
| Insulin level | Assessed by fasting blood (fast of 12 hours or more). | Up to 7 months from treatment onset | 
| Insulin level | Assessed by fasting blood (fast of 12 hours or more). | one year post-diagnosis | 
| Insulin level | Assessed by fasting blood (fast of 12 hours or more). | two years post-diagnosis | 
| C-reactive protein level | Assessed by fasting blood (fast of 12 hours or more). | Baseline (pre-chemotherapy) | 
| C-reactive protein level | Assessed by fasting blood (fast of 12 hours or more). | Up to 7 months from treatment onset | 
| C-reactive protein level | Assessed by fasting blood (fast of 12 hours or more). | one year post-diagnosis | 
| C-reactive protein level | Assessed by fasting blood (fast of 12 hours or more). | two years post-diagnosis | 
| Body composition-body weight | Assessed by measured weight | Baseline (pre-chemotherapy) | 
| Body composition-body mass index (BMI) | Assessed from measured weight and measured height | Baseline (pre-chemotherapy) | 
| Body composition-body fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Baseline (pre-chemotherapy) | 
| Body composition-lean body mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Baseline (pre-chemotherapy) | 
| Body composition-bone mineral density | Assessed by dual energy X-ray absorptiometry (DEXA) | Baseline (pre-chemotherapy) | 
| Body composition-body weight | Assessed by measured weight | Up to 7 months from treatment onset | 
| Body composition-body mass index (BMI) | Assessed from measured weight and measured height | Up to 7 months from treatment onset | 
| Body composition-body fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Up to 7 months from treatment onset | 
| Body composition-lean body mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Up to 7 months from treatment onset | 
| Body composition-bone mineral density | Assessed by dual energy X-ray absorptiometry (DEXA) | Up to 7 months from treatment onset | 
| Body composition-body weight | Assessed by measured weight | one year post-diagnosis | 
| Body composition-BMI | Assessed from measured weight and measured height | one year post-diagnosis | 
| Body composition-body fat | Assessed by dual energy X-ray absorptiometry (DEXA) | one year post-diagnosis | 
| Body composition-lean body mass | Assessed by dual energy X-ray absorptiometry (DEXA) | one year post-diagnosis | 
| Body composition-bone mineral density. | Assessed by dual energy X-ray absorptiometry (DEXA) | one year post-diagnosis | 
| Body composition-body weight | Assessed by measured weight | two years post-diagnosis | 
| Body composition-BMI | Assessed from measured weight and measured height | two years post-diagnosis | 
| Body composition-body fat | Assessed by dual energy X-ray absorptiometry (DEXA) | two years post-diagnosis | 
| Body composition-lean bone mass | Assessed by dual energy X-ray absorptiometry (DEXA) | two years post-diagnosis | 
| Body composition-bone mineral density | Assessed by dual energy X-ray absorptiometry (DEXA) | two years post-diagnosis | 
| Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Baseline (pre-chemotherapy) | 
| Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Up to 7 months from treatment onset | 
| Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | one year post-diagnosis | 
| Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | two years post-diagnosis | 
| fecal microbiome | Assessed by stool collection. | Baseline (pre-chemotherapy) | 
| Fecal microbiome | Assessed by stool collection. | Up to 7 months from treatment onset | 
| Fecal microbiome | Assessed by stool collection. | one year post-diagnosis | 
| Fecal microbiome | Assessed by stool collection. | two years post-diagnosis |