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Completed

NCT Number: NCT03314688

Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary/Physical Activity intervention

Behavioral

Motivational counseling to follow established dietary and exercise guidelines.

Usual Care

Behavioral

Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.

Primary outcomes

  1. Adherence to Treatment Measured by Chemotherapy Completion Rate

    Time frame: before initiating chemotherapy to post-chemotherapy, up to 7 months

    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.

  2. Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)

    Time frame: 12 months after enrollment

    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)

  3. Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).

    Time frame: 24 months after enrollment

    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)

Secondary outcomes

  1. Pathological Complete Response

    Time frame: At the time of surgical resection following initial course of chemotherapy

    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.

  2. Mean Insulin Level

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year

    Assessed by fasting blood (fast of 12 hours or more).

  3. Mean C-reactive Protein Level

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year

    Assessed by fasting blood (fast of 12 hours or more).

  4. Mean Body Composition-body Weight

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years

    Assessed by measured weight

  5. Mean Body Composition-body Mass Index (BMI)

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years

    Assessed from measured weight and measured height

  6. Mean Body Composition-body Fat

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years

    Assessed by dual energy X-ray absorptiometry (DEXA)

  7. Body Composition-lean Body Mass

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years

    Assessed by dual energy X-ray absorptiometry (DEXA)

  8. Body Composition-bone Mineral Density

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years

    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.

  9. Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years

    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.

  10. Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years

    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.

  11. Fecal Microbiome

    Time frame: Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year

    Number of participants that were able to provide a sample.

Other outcomes

  1. Minutes Per Week of Moderate/Vigorous Physical Activity

    Time frame: five years post-diagnosis

    Assessed by the modified physical activity questionnaire

  2. Healthy Eating Index

    Time frame: five years post-diagnosis

    Assessed by food frequency questionnaire

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2017
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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