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Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

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ClinicalTrials.gov Identifier: NCT03314688
Recruitment Status : Active, not recruiting
First Posted : October 19, 2017
Last Update Posted : June 11, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University

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

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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
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.




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.

  2. Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs) [ Time Frame: 12 months after enrollment ]
    Assessed by urinary aromatase inhibitor levels.

  3. Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs). [ Time Frame: 24 months after enrollment ]
    Assessed by urinary aromatase inhibitor levels.


Secondary Outcome Measures :
  1. Insulin level [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by fasting blood (fast of 12 hours or more).

  2. Insulin level [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by fasting blood (fast of 12 hours or more).

  3. Insulin level [ Time Frame: one year post-diagnosis ]
    Assessed by fasting blood (fast of 12 hours or more).

  4. Insulin level [ Time Frame: two years post-diagnosis ]
    Assessed by fasting blood (fast of 12 hours or more).

  5. C-reactive protein level [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by fasting blood (fast of 12 hours or more).

  6. C-reactive protein level [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by fasting blood (fast of 12 hours or more).

  7. C-reactive protein level [ Time Frame: one year post-diagnosis ]
    Assessed by fasting blood (fast of 12 hours or more).

  8. C-reactive protein level [ Time Frame: two years post-diagnosis ]
    Assessed by fasting blood (fast of 12 hours or more).

  9. Body composition-body weight [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by measured weight

  10. Body composition-body mass index (BMI) [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed from measured weight and measured height

  11. Body composition-body fat [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  12. Body composition-lean body mass [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  13. Body composition-bone mineral density [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  14. Body composition-body weight [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by measured weight

  15. Body composition-body mass index (BMI) [ Time Frame: Up to 7 months from treatment onset ]
    Assessed from measured weight and measured height

  16. Body composition-body fat [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  17. Body composition-lean body mass [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  18. Body composition-bone mineral density [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  19. Body composition-body weight [ Time Frame: one year post-diagnosis ]
    Assessed by measured weight

  20. Body composition-BMI [ Time Frame: one year post-diagnosis ]
    Assessed from measured weight and measured height

  21. Body composition-body fat [ Time Frame: one year post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  22. Body composition-lean body mass [ Time Frame: one year post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  23. Body composition-bone mineral density. [ Time Frame: one year post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  24. Body composition-body weight [ Time Frame: two years post-diagnosis ]
    Assessed by measured weight

  25. Body composition-BMI [ Time Frame: two years post-diagnosis ]
    Assessed from measured weight and measured height

  26. Body composition-body fat [ Time Frame: two years post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  27. Body composition-lean bone mass [ Time Frame: two years post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  28. Body composition-bone mineral density [ Time Frame: two years post-diagnosis ]
    Assessed by dual energy X-ray absorptiometry (DEXA)

  29. Quality of Life [ Time Frame: Baseline (pre-chemotherapy) ]
    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

  30. Quality of Life [ Time Frame: Up to 7 months from treatment onset ]
    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

  31. Quality of Life [ Time Frame: one year post-diagnosis ]
    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

  32. Quality of Life [ Time Frame: two years post-diagnosis ]
    Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.

  33. fecal microbiome [ Time Frame: Baseline (pre-chemotherapy) ]
    Assessed by stool collection.

  34. Fecal microbiome [ Time Frame: Up to 7 months from treatment onset ]
    Assessed by stool collection.

  35. Fecal microbiome [ Time Frame: one year post-diagnosis ]
    Assessed by stool collection.

  36. Fecal microbiome [ Time Frame: two years post-diagnosis ]
    Assessed by stool collection.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314688


Locations
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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
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Principal Investigator: Melinda Irwin, Ph.D. Yale University
Principal Investigator: Tara Sanft, M.D. Yale University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases