Triple Negative Breast Cancer
Conditions
Keywords
Exercise, Diet, Pathologic complete response, Neoadjuvant therapy
Brief summary
The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.
Detailed description
Women with stage II-III triple-negative breast cancer (TNBC) undergoing neoadjuvant chemo-immunotherapy will be enrolled in the study. Following screening, consent, and baseline assessment, participants will be randomized to either the intervention group (nutrition and exercise counseling) or the usual care group. Participants randomized to the intervention group will complete weekly remote sessions with the interventionist throughout the duration of chemotherapy. Each counseling session will last about 30 minutes and will be conducted remotely. The exercise regimen is home-based. Study activities include completing surveys and attending two in-person study visits, each of which will include a blood draw, a 6-minute walk test to assess aerobic capacity and endurance, and a Dual Energy X-Ray Absorptiometry (DXA) scan to measure body composition. The primary outcome is the pathologic complete response. Researchers will also compare the exercise and nutrition program to usual care to determine if the program improves residual cancer burden, symptoms related to cancer treatment, body composition, and blood biomarkers.
Interventions
BEHAVIORALExercise and Medical Nutrition
10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. On weeks counseling is not scheduled an exercise session will be observed.
Sponsors
Yale University
Breast Cancer Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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 will be unblinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female aged 18 years or older. 2. Have a diagnosis of stage II or III Triple Negative Breast Cancer (TNBC). 3. Be scheduled to receive neoadjuvant chemo-immunotherapy. 4. Be physically able to walk. 5. Be able to complete forms, understand instructions and read in English. 6. Agree to be randomly assigned to either group. 7. Have clearance from oncologist to participate. 8. Not exercising (less than 150 min/week). 9. Not consuming more than 7 fruits and vegetable/week.
Exclusion criteria
1. Having already started a 2nd chemotherapy cycle. 2. Pregnancy or intention to become pregnant. 3. Presence of dementia or major psychiatric disease. 4. Recent (past year) stroke, myocardial infarction, or congestive heart failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response (pCR) | Post breast cancer surgery, an average of 6 months | Pathologic Complete Response (pCR) is defined as having no invasive residual disease in the breast or regional lymph nodes after completing neoadjuvant chemotherapy (ypT0 ypN0 or ypT0/is ypN0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Cancer Burden (RCB) | Post breast cancer surgery, an average of 6 months | Residual Cancer Burden (RCB) is a continuous pCR measure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient reported toxicities | Baseline to end of first line chemotherapy, on average 6 months | Participants will be asked to complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey at baseline, 2-months, 4-months and the end of chemotherapy. |
| Physical function | Baseline to end of first line chemotherapy, on average 6 months | Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey. |
| Fatigue | Baseline to end of first line chemotherapy, on average 6 months | Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey. |
| Neuropathy | Baseline to end of first line chemotherapy, on average 6 months | Participants will be asked to complete the Functional Assessment of Cancer Therapy (FACT)-neuropathy subscale (FACT-Ntx). |
| Healthy Eating Index (HEI) | Baseline to end of first line chemotherapy, on average 6 months | Healthy Eating Index (HEI) will be will be estimated using the self-reported food frequency questionnaire developed by Fred Hutchinson Cancer Center. |
| Aerobic capacity | Baseline to end of first line chemotherapy, on average 6 months | Participants will be asked to complete a 6-minute walk test. |
| Lean mass | Baseline to end of first line chemotherapy, on average 6 months | Participants will be asked to complete a Dual Energy X-Ray Absorptiometry (DXA) scan |
| Percent fat | Baseline to end of first line chemotherapy, on average 6 months | Participants will be asked to complete a Dual Energy X-Ray Absorptiometry (DXA) scan |
| Malnutrition | Baseline to end of first line chemotherapy, on average 6 months | Participants will be asked to complete the Patient-Generated Subjective Global Assessment (PG-SGA). |
| Physical activity | Baseline to end of first line chemotherapy, on average 6 months | Self-reported minutes per week of moderate- to vigorous-intensity physical activity will be estimated using the modifiable physical activity questionnaire. |
Countries
United States
Contacts
Primary ContactMelinda Irwin
Outcome results
None listed