Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03314688
• Other study ID #: 2000020335
• Secondary ID: 1R01CA207753-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: July 31, 2026

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• Dietary/Physical Activity intervention
Motivational counseling to follow established dietary and exercise guidelines.
• Usual Care
Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Center	Boston	Massachusetts
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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.	before initiating chemotherapy to post-chemotherapy, up to 7 months
Primary	Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs)	Assessed by urinary aromatase inhibitor levels.	12 months after enrollment
Primary	Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs).	Assessed by urinary aromatase inhibitor levels.	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