Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

• Sponsor: Yale University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03314688
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 173
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 71.9
• Patients Per Site: 86.5
• Patients Per Site Per Month: 1.2

Study Details

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	N/A

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), and at two years post-diagnosis (Time 3): adherence to treatment, and changes in biomarkers, body composition, and quality of life.

Study Design

• Study Type: Interventional
• 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: Jan 2, 2018
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

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 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; 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 [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.

2. Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs) [12 months after enrollment]

   Assessed by urinary aromatase inhibitor levels.

3. Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs). [24 months after enrollment]

   Assessed by urinary aromatase inhibitor levels.

Secondary Outcome Measures

1. Insulin level [Baseline (pre-chemotherapy)]

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

2. Insulin level [Up to 7 months from treatment onset]

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

3. Insulin level [one year post-diagnosis]

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

4. Insulin level [two years post-diagnosis]

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

5. C-reactive protein level [Baseline (pre-chemotherapy)]

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

6. C-reactive protein level [Up to 7 months from treatment onset]

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

7. C-reactive protein level [one year post-diagnosis]

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

8. C-reactive protein level [two years post-diagnosis]

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

9. Body composition-body weight [Baseline (pre-chemotherapy)]

   Assessed by measured weight

10. Body composition-body mass index (BMI) [Baseline (pre-chemotherapy)]

    Assessed from measured weight and measured height

11. Body composition-body fat [Baseline (pre-chemotherapy)]

    Assessed by dual energy X-ray absorptiometry (DEXA)

12. Body composition-lean body mass [Baseline (pre-chemotherapy)]

    Assessed by dual energy X-ray absorptiometry (DEXA)

13. Body composition-bone mineral density [Baseline (pre-chemotherapy)]

    Assessed by dual energy X-ray absorptiometry (DEXA)

14. Body composition-body weight [Up to 7 months from treatment onset]

    Assessed by measured weight

15. Body composition-body mass index (BMI) [Up to 7 months from treatment onset]

    Assessed from measured weight and measured height

16. Body composition-body fat [Up to 7 months from treatment onset]

    Assessed by dual energy X-ray absorptiometry (DEXA)

17. Body composition-lean body mass [Up to 7 months from treatment onset]

    Assessed by dual energy X-ray absorptiometry (DEXA)

18. Body composition-bone mineral density [Up to 7 months from treatment onset]

    Assessed by dual energy X-ray absorptiometry (DEXA)

19. Body composition-body weight [one year post-diagnosis]

    Assessed by measured weight

20. Body composition-BMI [one year post-diagnosis]

    Assessed from measured weight and measured height

21. Body composition-body fat [one year post-diagnosis]

    Assessed by dual energy X-ray absorptiometry (DEXA)

22. Body composition-lean body mass [one year post-diagnosis]

    Assessed by dual energy X-ray absorptiometry (DEXA)

23. Body composition-bone mineral density. [one year post-diagnosis]

    Assessed by dual energy X-ray absorptiometry (DEXA)

24. Body composition-body weight [two years post-diagnosis]

    Assessed by measured weight

25. Body composition-BMI [two years post-diagnosis]

    Assessed from measured weight and measured height

26. Body composition-body fat [two years post-diagnosis]

    Assessed by dual energy X-ray absorptiometry (DEXA)

27. Body composition-lean bone mass [two years post-diagnosis]

    Assessed by dual energy X-ray absorptiometry (DEXA)

28. Body composition-bone mineral density [two years post-diagnosis]

    Assessed by dual energy X-ray absorptiometry (DEXA)

29. Quality of Life [Baseline (pre-chemotherapy)]

    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

30. Quality of Life [Up to 7 months from treatment onset]

    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

31. Quality of Life [one year post-diagnosis]

    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

32. Quality of Life [two years post-diagnosis]

    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

33. fecal microbiome [Baseline (pre-chemotherapy)]

    Assessed by stool collection.

34. Fecal microbiome [Up to 7 months from treatment onset]

    Assessed by stool collection.

35. Fecal microbiome [one year post-diagnosis]

    Assessed by stool collection.

36. Fecal microbiome [two years post-diagnosis]

    Assessed by stool collection.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06510
2	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)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03314688
• Other Study ID Numbers: 2000020335; 1R01CA207753-01A1
• First Posted: Oct 19, 2017
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jul 13, 2022