Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging

UNC Lineberger Comprehensive Cancer Center132 enrolled

Overview

Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. Participants: 200 patients age 21 or older 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 200 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.

The overall focus of this study remains the investigation of associations between p16 and assessments (independent and patient-reported) of chemotherapy-related toxicity (adverse events and symptoms) and patient-reported measures of function and quality of life. The research team has determined that p16 increases dramatically during chemotherapy and that p16 levels among persons of similar age are lower among those who exercise as compared to those who are sedentary. The research team hypothesizes that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, the study proposes to build on a completed trial, LCCC1334, and enroll 200 evaluable patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in an intervention that entails both aerobic and resistance exercises. Results from both LCCC1334 and LCCC1410 and the proposed study, LCCC1749, will be used to provide evidence for a future grant application to conduct a randomized controlled trial in a larger study population to (1) establish the effect of physical activity on p16 levels during chemotherapy and (2) further evaluate how baseline and post-chemotherapy p16 levels correlate with measures of treatment-related toxicity and patient-reported outcomes over time. Findings from this study will also provide preliminary evidence for further investigations of the potential benefits of exercise during early breast cancer chemotherapy for (1) reducing the incidence and severity of peripheral neuropathy and (2) managing the interface of fatigue and perceived cognition deficits.

Study Type

INTERVENTIONAL

Allocation

Interventions

Engagement in Physical ActivityBEHAVIORAL

Study participants will be asked to wear a FitBit provided by the research team and agree to FitBit data downloads during regularly scheduled chemotherapy clinic visits. Participants will also complete a daily exercise log to record the total number of minutes walked and the total number of steps from the FitBit.

QuestionnairesOTHER

Study participants will complete the following questionnaires: Health Behavior Questionnaire (HBQ), Short Physical Performance Battery (SPPB), Functional Assessment of Cancer Therapy-General (FACT-G), 4.4.5 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), PROMIS Cognitive Function (Short Form 8a), Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) Version 4, Nutrition Survey, Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM),

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Study subjects must meet all of the inclusion criteria listed below to participate in this study: * 21 years of age or older, 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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 6-months post Baseline, 12-months post-Baseline

Secondary Outcomes

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.

Time frame: 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

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.

Time frame: Baseline, 3-months post-Baseline, 6-months post-Baseline, and 12-months post-Baseline

Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the FACT/GOG-NTX

Will administer the FACT/GOG-NTX instrument.

Time frame: 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

Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the CTCAE.

Will administer the CTCAE.

Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the PRO-CTCAE.

Will administer the PRO-CTCAE.

Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the SPPB.

Will administer the Short Physical Performance Battery (SPPB).

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.

Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline

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.

Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline

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.

Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline

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.

Time frame: Baseline, 6-months post-Baseline, 12-months post Baseline

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.

Time frame: Baseline, 6-months post Baseline, 12-months post-Baseline

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.

Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline

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.

Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline

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.