Breast Neoplasms Clinical Trial
Official title:
Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (LEANer)
Verified date | April 2024 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 173 |
Est. completion date | July 31, 2026 |
Est. primary completion date | March 24, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Center | Boston | Massachusetts |
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | before initiating chemotherapy to post-chemotherapy, up to 7 months | |
Primary | 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) In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted) In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted) |
12 months after enrollment | |
Primary | 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) |
24 months after enrollment | |
Secondary | 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 | |
Secondary | Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | Baseline (pre-chemotherapy) | |
Secondary | Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | Up to 7 months from treatment onset | |
Secondary | Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | one year post-diagnosis | |
Secondary | Insulin Level | Assessed by fasting blood (fast of 12 hours or more). | two years post-diagnosis | |
Secondary | C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | Baseline (pre-chemotherapy) | |
Secondary | C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | Up to 7 months from treatment onset | |
Secondary | C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | one year post-diagnosis | |
Secondary | C-reactive Protein Level | Assessed by fasting blood (fast of 12 hours or more). | two years post-diagnosis | |
Secondary | Body Composition-body Weight | Assessed by measured weight | Baseline (pre-chemotherapy) | |
Secondary | Body Composition-body Mass Index (BMI) | Assessed from measured weight and measured height | Baseline (pre-chemotherapy) | |
Secondary | Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Baseline (pre-chemotherapy) | |
Secondary | Body Composition-lean Body Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Baseline (pre-chemotherapy) | |
Secondary | Body Composition-bone Mineral Density | Assessed by dual energy X-ray absorptiometry (DEXA) | Baseline (pre-chemotherapy) | |
Secondary | Body Composition-body Weight | Assessed by measured weight | Up to 7 months from treatment onset | |
Secondary | Body Composition-body Mass Index (BMI) | Assessed from measured weight and measured height | Up to 7 months from treatment onset | |
Secondary | Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | Up to 7 months from treatment onset | |
Secondary | Body Composition-lean Body Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | Up to 7 months from treatment onset | |
Secondary | Body Composition-bone Mineral Density | Assessed by dual energy X-ray absorptiometry (DEXA) | Up to 7 months from treatment onset | |
Secondary | Body Composition-body Weight | Assessed by measured weight | one year post-diagnosis | |
Secondary | Body Composition-BMI | Assessed from measured weight and measured height | one year post-diagnosis | |
Secondary | Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | one year post-diagnosis | |
Secondary | Body Composition-lean Body Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | one year post-diagnosis | |
Secondary | Body Composition-bone Mineral Density. | Assessed by dual energy X-ray absorptiometry (DEXA) | one year post-diagnosis | |
Secondary | Body Composition-body Weight | Assessed by measured weight | two years post-diagnosis | |
Secondary | Body Composition-BMI | Assessed from measured weight and measured height | two years post-diagnosis | |
Secondary | Body Composition-body Fat | Assessed by dual energy X-ray absorptiometry (DEXA) | two years post-diagnosis | |
Secondary | Body Composition-lean Bone Mass | Assessed by dual energy X-ray absorptiometry (DEXA) | two years post-diagnosis | |
Secondary | Body Composition-bone Mineral Density | Assessed by dual energy X-ray absorptiometry (DEXA) | two years post-diagnosis | |
Secondary | Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Baseline (pre-chemotherapy) | |
Secondary | Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | Up to 7 months from treatment onset | |
Secondary | Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | one year post-diagnosis | |
Secondary | Quality of Life | Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. | two years post-diagnosis | |
Secondary | Fecal Microbiome | Assessed by stool collection. | Baseline (pre-chemotherapy) | |
Secondary | Fecal Microbiome | Assessed by stool collection. | Up to 7 months from treatment onset | |
Secondary | Fecal Microbiome | Assessed by stool collection. | one year post-diagnosis | |
Secondary | Fecal Microbiome | Assessed by stool collection. | two years post-diagnosis | |
Secondary | Healthy Eating Index | Assessed by food frequency questionnaire | five years post-diagnosis | |
Secondary | Minutes Per Week of Moderate/Vigorous Physical Activity | Assessed by the modified physical activity questionnaire | five years post-diagnosis |
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