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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. The other group will not receive a exercise prescription but their activity will be recorded. The hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.
This is a prospective, randomized, single institution feasibility trial. The efficacy of an exercise intervention during chemotherapy for sedentary breast cancer patients will be tested. The investigators goal is to recruit 120 women and men. Assuming 20% attrition rate, 96 will be randomized to two arms, comparing patients assigned to a physical activity program plus general health education materials versus patients assigned to receive standard general health education materials only. Study measures will be obtained before intervention, at 24 weeks, and at the end of the intervention, approximately week 32.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | No Intervention | Physical Therapy consult for post op care and general physical activity recommendation 1-4 weeks prior to starting chemotherapy. Phone calls designed to support the patient to maintain current activity level. | |
| Arm B | Placebo Comparator | Physical Therapy consult for post-op care 1-4 weeks prior to starting chemotherapy. Exercise prescription aimed at increasing physical activity by a minimum of 10 MET hours/week. Motivational phone calls aimed at encouraging the patient to adhere to their exercise prescription. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise prescription | Behavioral | A physical therapist will design an exercise plan for each participant on the intervention arm. The participants randomized to the intervention arm will also receive phone calls to assist with tracking the study participant's exercise and motivating the study participant to adhere to the exercise prescription. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in activity as measured by the Activity Log | A log will be used to record patient's exercise activity and pedometer data on a weekly and monthly basis. | from baseline to week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Received Dose Intensity of chemotherapy (RDI) | The RDI is calculated by (delivered dose)/(standard dose) x 100. Delivered dose = (actual total dose in mg/m2)/ (total days required to complete the treatment) Standard dose = (recommended total dose) / (total days planned to complete the treatment) | 32 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary Chamberlin, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2016 | Aug 4, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F |
Fatigue as measured by the FACIT-F survey |
| baseline (Day -28 to 1), week 24, 32 weeks |
| Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin | baseline (Day -28 to 1), 32 weeks |
| Change from Baseline (day -28 to day 1) C-reactive protein | levels of C- reactive protein | Baseline (day -28 to day 1) and week 32 |
| Change from Baseline (Day -28 to day 1) Fasting insulin | Fasting insulin levels measured in blood at baseline (day -28 to day 1) and week 32 | Baseline (day -28 to day 1) and week 32 |
| Change from Baseline (day -28 to day 1) of Resting metabolic rate (calculated by Respiratory quotient/ resting energy expenditure measured in kcal/day) | baseline (day -28 to day 1) and week 32 |
| Change in Body composition as indicated by % of total body fat, bone density (g/cm2), and T score | baseline (day -28 to day 1) and week 32 |
| Change in Resting heart rate from baseline (day -28 to day 1) | baseline (day -28 to day 1) and week 32 |
| Change in Waist-hip ratio from baseline (day -28 to day 1) | baseline (day -28 to day 1) and week 32 |
| Change in steps recorded from baseline (day -28 to day 1) as measure by Pedometer data | Average steps per week for weeks 1-32 | weekly for 32 weeks |
| Measures how likely a person is to continue with exercise prescription. | How the participant is feeling about the exercise. | From baseline to Week 32 |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
Not provided
Not provided