Clinical trial NCT03761706: Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
exercise
chemotherapy and aging
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2018-12-03
Enrollment: 132
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare the change in p16 from baseline to end of chemotherapy
timeFrame: Baseline, 6-months post Baseline, 12-months post-Baseline
Secondary outcomes:
measure: Measure association of physical activity levels (Fitbit steps and strength training) with change in p16 levels
timeFrame: 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: Measure associations between weight, physical activity and diet during chemotherapy.
timeFrame: Baseline, 3-months post-Baseline, 6-months post-Baseline, and 12-months post-Baseline
measure: Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the FACT/GOG-NTX
timeFrame: 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
measure: Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the CTCAE.
timeFrame: 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
measure: Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the PRO-CTCAE.
timeFrame: 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
measure: Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the SPPB.
timeFrame: 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
measure: Measure association of p16 with changes in QOL measures as assessed by the FACT-G
timeFrame: Baseline, 6-months post-Baseline, 12-months post-Baseline
measure: Measure association of p16 with changes in QOL measures as assessed by the FACIT-F
timeFrame: Baseline, 6-months post-Baseline, 12-months post-Baseline
measure: Measure association of p16 with changes in QOL measures as assessed by the MHI-17
timeFrame: Baseline, 6-months post-Baseline, 12-months post-Baseline
measure: Measure association of p16 with changes in QOL measures as assessed by the MOS Social Activity Limitation Questionnaire
timeFrame: Baseline, 6-months post-Baseline, 12-months post Baseline
measure: Measure association of p16 with changes in QOL measures as assessed by the PROMIS Instrumental Support
timeFrame: Baseline, 6-months post Baseline, 12-months post-Baseline
measure: Measure association of p16 with changes in QOL measures as assessed by the PROMIS Social Isolation Questionnaire.
timeFrame: Baseline, 6-months post-Baseline, 12-months post-Baseline
measure: Measure association of p16 with changes in QOL measures as assessed by the PROMIS Global Health
timeFrame: Baseline, 6-months post-Baseline, 12-months post-Baseline
measure: Measure association of p16 with changes in cognition by the PROMIS Cognitive Function-Short Form
timeFrame: Baseline, 6-months post-Baseline
measure: Measure association of p16 with changes in cognition by the Blessed Memory Concentration test (BOMC)
timeFrame: Baseline, 6-months post-Baseline
measure: Measure association of p16 with changes in functional status by the Timed Up and Go Test
timeFrame: Baseline, 6-months post-Baseline
measure: Measure association of p16 with changes in functional status by the Medical Outcomes Survey.
timeFrame: Baseline, 6-months post-Baseline
measure: Measure association of p16 with changes in functional status with the Instrumental Activities of Daily Living Survey
timeFrame: Baseline, 6-months post-Baseline
measure: Measure association of p16 with changes in functional status with the Karnofsky Performance Status
timeFrame: Baseline, 6-months post-Baseline
measure: Measure association of p16 with number of Fall Questionnaire
timeFrame: Baseline, 6-months post-Baseline
measure: Measure association of p16 with limitations in walking one block
timeFrame: Baseline, 6-months post-Baseline
Other outcomes:
measure: Measure association of p16 with body composition
timeFrame: 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
measure: Mean change in p16 between baseline to end of chemo, compared to previous studies
timeFrame: Baseline, 6-months post-Baseline
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Hyman B. Muss, MD
role: PRINCIPAL_INVESTIGATOR
References: