Breast Cancer Clinical Trial
Official title:
Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging and Patient-reported Symptoms and Outcomes
Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. Participants: 100 patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy. Procedures: The study entails screening, recruiting and consenting 100 eligible breast cancer patients who are about to begin adjuvant or neoadjuvant chemotherapy and agree to participate in a physical activity intervention, maintain a printed daily exercise log, wear a FitBit, complete questionnaires and assessments, and provide blood samples at various time points.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 15, 2025 |
Est. primary completion date | November 15, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 64 Years |
Eligibility | Inclusion Criteria: - Study subjects must meet all of the inclusion criteria listed below to participate in this study: - 21 to 64 years of age, female - Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis) - Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org). Patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen. - English speaking - IRB approved, signed written informed consent - Approval from their treating physician to engage in moderate-intensity physical activity - Patient-assessed ability to walk and engage in moderate physical activity - Willing and able to meet all study requirements. Exclusion Criteria: - All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria are: - One or more significant medical conditions that in the physician's judgment preclude participation in the walking or strength training intervention. - Unable to walk or engage in moderate-intensity physical activity. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | Breast Cancer Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Measure association of p16 with body composition | Evaluate the association of p16 with body composition measures (Bioimpedence, DEXA or BMI) at baseline and over time. p16 is the outcome of interest. We will analyze the correlation between p16 and (1) DEXA or (2) BMI or (3) bioimpedence -- BMI will be available for all participants, while DEXA and bioimpedence measures will not necessarily be available for all participants. | Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post-Baseline and 12-months post-Baseline | |
Other | Mean change in p16 between baseline to end of chemo, compared to previous studies | Mean change in p16 levels measured between baseline to end of chemotherapy, as compared to the historical value seen in previous studies (LCCC810 and 1027) of similar patients who did not participate in a physical activity intervention | Baseline, 6-months post-Baseline | |
Primary | Compare the change in p16 from baseline to end of chemotherapy | Compare the change in p16 from baseline to end of chemotherapy for patients receiving a physical activity intervention to the historical value seen in previous studies (LCCC810 and 1027) of similar patients who did not participate in a physical activity intervention. | Baseline, 6-months post Baseline, 12-months post-Baseline | |
Secondary | Measure association of physical activity levels (Fitbit steps and strength training) with change in p16 levels | Will upload Fitbit and collect strength training data to evaluate the association of physical activity levels (Fitbit steps) with change in p16 levels. | Baseline, during Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks) , and 12-months post-Baseline | |
Secondary | Measure associations between weight, physical activity and diet during chemotherapy. | Will administer the NHANES Nutrition Survey at several time points during the study. The NHANES survey is not a scale. It is not scored. It is descriptive, asking about the frequency of consumption of specific items. | Baseline, 3-months post-Baseline, 6-months post-Baseline, and 12-months post-Baseline | |
Secondary | Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the FACT/GOG-NTX | Will administer the FACT/GOG-NTX instrument. | Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline | |
Secondary | Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the CTCAE. | Will administer the CTCAE. | Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline | |
Secondary | Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the PRO-CTCAE. | Will administer the PRO-CTCAE. | Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline | |
Secondary | Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the SPPB. | Will administer the Short Physical Performance Battery (SPPB). | Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline | |
Secondary | Measure association of p16 with changes in QOL measures as assessed by the FACT-G | Will administer the FACT-G Questionnaire. The FACT-G is scored in a Likert-type scale from 0+not at all to 4=very much. Higher scores signify higher quality of life. Subscales are physical, social/family, emotional and functional -- which are analyzed separately and can be combined into a total FACT-G score. | Baseline, 6-months post-Baseline, 12-months post-Baseline | |
Secondary | Measure association of p16 with changes in QOL measures as assessed by the FACIT-F | Will administer the FACIT-F Questionnaire. This Likert-type scale ranges from 0=not at all to 4=very much, with higher scores signifying higher fatigue. No subscales. | Baseline, 6-months post-Baseline, 12-months post-Baseline | |
Secondary | Measure association of p16 with changes in QOL measures as assessed by the MHI-17 | Will administer the MHI-17 Health Questionnaire. This 17 item measure consists of two subscales -- Anxiety and Depression. The Likert-type scale ranges from 0=all of the time to 5=none of the time. Higher scores indicate higher anxiety or depression. The two subscales are not combined into one MHI score. | Baseline, 6-months post-Baseline, 12-months post-Baseline | |
Secondary | Measure association of p16 with changes in QOL measures as assessed by the MOS Social Activity Limitation Questionnaire | Administer the MOS Social Activity Limitation Questionnaire. We are using only one item from this scale. Likert-type scoring is 0=all of the time to4=none of the time. Higher score signifies less interference with social activities. | Baseline, 6-months post-Baseline, 12-months post Baseline | |
Secondary | Measure association of p16 with changes in QOL measures as assessed by the PROMIS Instrumental Support | Administer the PROMIS Instrumental Support Questionnaire. This Likert-type scale is from 1=never to 5=always. Higher score signifies higher instrumental support. No subscales. | Baseline, 6-months post Baseline, 12-months post-Baseline | |
Secondary | Measure association of p16 with changes in QOL measures as assessed by the PROMIS Social Isolation Questionnaire. | Administer PROMIS Social Isolation Questionnaire. Likert-type scoring is 0=never to 5=alwayse. Higher score signifies more social isolation. No subscales. | Baseline, 6-months post-Baseline, 12-months post-Baseline | |
Secondary | Measure association of p16 with changes in QOL measures as assessed by the PROMIS Global Health | Administer PROMIS Global Health Questionnaire. Likert-type scale from 0=excellent to 4=poor. Higher score signifies lower global health. No subscales. | Baseline, 6-months post-Baseline, 12-months post-Baseline | |
Secondary | Measure association of p16 with changes in cognition by the PROMIS Cognitive Function-Short Form | Will administer the PROMIS Cognitive Function-Short Form (8a). This Likert-type scale is from 1=very often to 5=never. Higher scores signify higher cognitive function. No subscales. | Baseline, 6-months post-Baseline | |
Secondary | Measure association of p16 with changes in cognition by the Blessed Memory Concentration test (BOMC) | Will administer the Blessed Memory Concentration test (BOMC). | Baseline, 6-months post-Baseline | |
Secondary | Measure association of p16 with changes in functional status by the Timed Up and Go Test | Administer theTimed Up and Go Test | Baseline, 6-months post-Baseline | |
Secondary | Measure association of p16 with changes in functional status by the Medical Outcomes Survey. | Administer the Medical Outcomes Survey. Likert-type scale from 0=without help to 2=completely unable. Higher score signifies more limitations. No subscale. | Baseline, 6-months post-Baseline | |
Secondary | Measure association of p16 with changes in functional status with the Instrumental Activities of Daily Living Survey | Administer the Instrumental Activities of Daily Living Survey. This Likelrt-type scale is from 0=without help to 2=completely unable. Higher scores signify greater limitations. No subscale. | Baseline, 6-months post-Baseline | |
Secondary | Measure association of p16 with changes in functional status with the Karnofsky Performance Status | Administer the Karnofsky Performance Status | Baseline, 6-months post-Baseline | |
Secondary | Measure association of p16 with number of Fall Questionnaire | One question will inquire about falls within the past 6 months. | Baseline, 6-months post-Baseline | |
Secondary | Measure association of p16 with limitations in walking one block | One question will inquire whether the participant's health limits their ability to walk one block = range 0=limited a lot to 2=not limited at all | Baseline, 6-months post-Baseline |
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