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.
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), at two years post-diagnosis (Time 3), and at five-years post-diagnosis (Time 4): adherence to treatment, and changes in biomarkers, body composition, diet, physical activity and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
173
Motivational counseling to follow established dietary and exercise guidelines.
Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
Yale University
New Haven, Connecticut, United States
Dana Farber Cancer Center
Boston, Massachusetts, United States
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. RDI is calculated by dividing the participant's actual dose by the planned dose to get a percentage of actual dose/planned dose.
Time frame: before initiating chemotherapy to post-chemotherapy, up to 7 months
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. 1. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted) 2. In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted) 3. In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted)
Time frame: 12 months after enrollment
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).
This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted- Q1) In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q2) In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q3)
Time frame: 24 months after enrollment
Pathological Complete Response
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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. Data presented here is the number of participants with a pathological Complete Response.
Time frame: At the time of surgical resection following initial course of chemotherapy
Mean Insulin Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Mean C-reactive Protein Level
Assessed by fasting blood (fast of 12 hours or more).
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Mean Body Composition-body Weight
Assessed by measured weight
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Body Composition-body Mass Index (BMI)
Assessed from measured weight and measured height
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Body Composition-body Fat
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Body Composition-lean Body Mass
Assessed by dual energy X-ray absorptiometry (DEXA)
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Body Composition-bone Mineral Density
Assessed by dual energy X-ray absorptiometry (DEXA), -1.0 or higher are normal; -1.1 to -2.4 indicate low bone mass (osteopenia), and -2.5 or lower indicate osteoporosis.
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)
PROMIS Global Physical Health (GPH) score is a measure of physical well-being. It uses a T-score metric standardized to a U.S. general population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health, with scores typically ranging from 20 to 80.
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)
PROMIS Global Mental Health (GMH) score is a measure of mental well-being. It uses a T-score metric standardized to a U.S. general population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health, with scores typically ranging from 20 to 80.
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Fecal Microbiome
Number of participants that were able to provide a sample.
Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year