Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and Medical Nutrition | Experimental | Women randomized to the intervention will receive 10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. In weeks in which one of the 10 counseling sessions is not scheduled the interventionist will observe the participant in an exercise session via zoom, or check in with the participant by phone regarding their exercise. The intervention will continue until the day prior to the last chemotherapy infusion. |
|
| Usual care | No Intervention | Contact limited to study assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise and Medical Nutrition | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) | 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) | Post breast cancer surgery, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Cancer Burden (RCB) | Residual Cancer Burden (RCB) is a continuous pCR measure. | Post breast cancer surgery, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Healthy Eating Index (HEI) | Healthy Eating Index (HEI) will be will be estimated using the self-reported food frequency questionnaire developed by Fred Hutchinson Cancer Center. | Baseline to end of first line chemotherapy, on average 6 months |
| Physical activity |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melinda Irwin | Contact | 203-785-6392 | melinda.irwin@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melinda Irwin | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06511 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D009043 | Motor Activity |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Self-reported minutes per week of moderate- to vigorous-intensity physical activity will be estimated using the modifiable physical activity questionnaire. |
| Baseline to end of first line chemotherapy, on average 6 months |
| Patient reported toxicities | 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. | Baseline to end of first line chemotherapy, on average 6 months |
| Physical function | Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey. | Baseline to end of first line chemotherapy, on average 6 months |
| Fatigue | Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey. | Baseline to end of first line chemotherapy, on average 6 months |
| Neuropathy | Participants will be asked to complete the Functional Assessment of Cancer Therapy (FACT)-neuropathy subscale (FACT-Ntx). | Baseline to end of first line chemotherapy, on average 6 months |
| Malnutrition | Participants will be asked to complete the Patient-Generated Subjective Global Assessment (PG-SGA). | Baseline to end of first line chemotherapy, on average 6 months |
| Aerobic capacity | Participants will be asked to complete a 6-minute walk test. | Baseline to end of first line chemotherapy, on average 6 months |
| Lean mass | Participants will be asked to complete a Dual Energy X-Ray Absorptiometry (DXA) scan | Baseline to end of first line chemotherapy, on average 6 months |
| Percent fat | Participants will be asked to complete a Dual Energy X-Ray Absorptiometry (DXA) scan | Baseline to end of first line chemotherapy, on average 6 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |