Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

• ClinicalTrials.gov Identifier: NCT03314688
• Recruitment Status: Active, not recruiting
• First Posted: October 19, 2017
• Results First Posted: May 14, 2024
• Last Update Posted: May 14, 2024
• Sponsor: Yale University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Yale University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms	Behavioral: Dietary/Physical Activity intervention; Behavioral: Usual Care	Not Applicable

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 173 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Masking Description: The following study personnel will be masked to participant study arm: the staff performing DXA scan and blood processing/biomarker evaluation. The staff performing clinic measures, study staff reviewing forms and entering data, the PI and Co-Is, the statistician, study manager, and interventionists (study dieticians) will be unblinded.
• Primary Purpose: Other
• Official Title: Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (LEANer)
• Actual Study Start Date: January 2, 2018
• Actual Primary Completion Date: March 24, 2023
• Estimated Study Completion Date: July 31, 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual Care Group; 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.	Behavioral: Usual Care; Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
Experimental: Dietary/Physical Activity 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).	Behavioral: Dietary/Physical Activity intervention; Motivational counseling to follow established dietary and exercise guidelines.

Outcome Measures

Primary Outcome Measures :

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.

   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)
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 Outcome Measures :

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.
2. Insulin Level [ Time Frame: Baseline (pre-chemotherapy) ]
   Assessed by fasting blood (fast of 12 hours or more).
3. Insulin Level [ Time Frame: Up to 7 months from treatment onset ]
   Assessed by fasting blood (fast of 12 hours or more).
4. Insulin Level [ Time Frame: one year post-diagnosis ]
   Assessed by fasting blood (fast of 12 hours or more).
5. Insulin Level [ Time Frame: two years post-diagnosis ]
   Assessed by fasting blood (fast of 12 hours or more).
6. C-reactive Protein Level [ Time Frame: Baseline (pre-chemotherapy) ]
   Assessed by fasting blood (fast of 12 hours or more).
7. C-reactive Protein Level [ Time Frame: Up to 7 months from treatment onset ]
   Assessed by fasting blood (fast of 12 hours or more).
8. C-reactive Protein Level [ Time Frame: one year post-diagnosis ]
   Assessed by fasting blood (fast of 12 hours or more).
9. C-reactive Protein Level [ Time Frame: two years post-diagnosis ]
   Assessed by fasting blood (fast of 12 hours or more).
10. Body Composition-body Weight [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by measured weight
11. Body Composition-body Mass Index (BMI) [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed from measured weight and measured height
12. Body Composition-body Fat [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
13. Body Composition-lean Body Mass [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
14. Body Composition-bone Mineral Density [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
15. Body Composition-body Weight [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by measured weight
16. Body Composition-body Mass Index (BMI) [ Time Frame: Up to 7 months from treatment onset ]
    Assessed from measured weight and measured height
17. Body Composition-body Fat [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
18. Body Composition-lean Body Mass [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
19. Body Composition-bone Mineral Density [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
20. Body Composition-body Weight [ Time Frame: one year post-diagnosis ]
    Assessed by measured weight
21. Body Composition-BMI [ Time Frame: one year post-diagnosis ]
    Assessed from measured weight and measured height
22. Body Composition-body Fat [ Time Frame: one year post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
23. Body Composition-lean Body Mass [ Time Frame: one year post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
24. Body Composition-bone Mineral Density. [ Time Frame: one year post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
25. Body Composition-body Weight [ Time Frame: two years post-diagnosis ]
    Assessed by measured weight
26. Body Composition-BMI [ Time Frame: two years post-diagnosis ]
    Assessed from measured weight and measured height
27. Body Composition-body Fat [ Time Frame: two years post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
28. Body Composition-lean Bone Mass [ Time Frame: two years post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
29. Body Composition-bone Mineral Density [ Time Frame: two years post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)
30. Quality of Life [ Time Frame: Baseline (pre-chemotherapy) ]
    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
31. Quality of Life [ Time Frame: Up to 7 months from treatment onset ]
    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
32. Quality of Life [ Time Frame: one year post-diagnosis ]
    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
33. Quality of Life [ Time Frame: two years post-diagnosis ]
    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.
34. Fecal Microbiome [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by stool collection.
35. Fecal Microbiome [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by stool collection.
36. Fecal Microbiome [ Time Frame: one year post-diagnosis ]
    Assessed by stool collection.
37. Fecal Microbiome [ Time Frame: two years post-diagnosis ]
    Assessed by stool collection.
38. Healthy Eating Index [ Time Frame: five years post-diagnosis ]
    Assessed by food frequency questionnaire
39. Minutes Per Week of Moderate/Vigorous Physical Activity [ Time Frame: five years post-diagnosis ]
    Assessed by the modified physical activity questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06510

United States, Massachusetts

Dana Farber Cancer Center

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Yale University

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Melinda Irwin, Ph.D.; Yale University
• Principal Investigator: Tara Sanft, M.D.; Yale University

  Study Documents (Full-Text)

Documents provided by Yale University:

Study Protocol and Statistical Analysis Plan  [PDF] January 14, 2024

Informed Consent Form  [PDF] February 4, 2021

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sanft T, Harrigan M, Cartmel B, Ferrucci LM, Li FY, McGowan C, Zupa M, Nguyen TH, Ligibel J, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones B, Knobf T, Chagpar A, Silber A, Irwin ML. Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial. Contemp Clin Trials. 2021 Oct;109:106508. doi: 10.1016/j.cct.2021.106508. Epub 2021 Jul 16.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03314688
• Other Study ID Numbers: 2000020335; 1R01CA207753-01A1 ( U.S. NIH Grant/Contract )
• First Posted: October 19, 2017
• Results First Posted: May 14, 2024
• Last Update Posted: May 14, 2024
• Last Verified: April 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases