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Completed

NCT Number: NCT03761706

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

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Engagement in Physical Activity

Behavioral

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.

questionnaires

Other

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),

Primary outcomes

  1. Compare the change in p16 from baseline to end of chemotherapy

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

    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.

Secondary outcomes

  1. Measure association of physical activity levels (Fitbit steps and strength training) 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

    Will upload Fitbit and collect strength training data to evaluate the association of physical activity levels (Fitbit steps) with change in p16 levels.

  2. Measure associations between weight, physical activity and diet during chemotherapy.

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

    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.

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

    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

    Will administer the FACT/GOG-NTX instrument.

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

    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

    Will administer the CTCAE.

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

    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

    Will administer the PRO-CTCAE.

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

    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

    Will administer the Short Physical Performance Battery (SPPB).

  7. Measure association of p16 with changes in QOL measures as assessed by the FACT-G

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

    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.

  8. Measure association of p16 with changes in QOL measures as assessed by the FACIT-F

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

    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.

  9. Measure association of p16 with changes in QOL measures as assessed by the MHI-17

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

    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.

  10. Measure association of p16 with changes in QOL measures as assessed by the MOS Social Activity Limitation Questionnaire

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

    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.

  11. Measure association of p16 with changes in QOL measures as assessed by the PROMIS Instrumental Support

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

    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.

  12. Measure association of p16 with changes in QOL measures as assessed by the PROMIS Social Isolation Questionnaire.

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

    Administer PROMIS Social Isolation Questionnaire. Likert-type scoring is 0=never to 5=alwayse. Higher score signifies more social isolation. No subscales.

  13. Measure association of p16 with changes in QOL measures as assessed by the PROMIS Global Health

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

    Administer PROMIS Global Health Questionnaire. Likert-type scale from 0=excellent to 4=poor. Higher score signifies lower global health. No subscales.

  14. Measure association of p16 with changes in cognition by the PROMIS Cognitive Function-Short Form

    Time frame: Baseline, 6-months post-Baseline

    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.

  15. Measure association of p16 with changes in cognition by the Blessed Memory Concentration test (BOMC)

    Time frame: Baseline, 6-months post-Baseline

    Will administer the Blessed Memory Concentration test (BOMC).

  16. Measure association of p16 with changes in functional status by the Timed Up and Go Test

    Time frame: Baseline, 6-months post-Baseline

    Administer theTimed Up and Go Test

  17. Measure association of p16 with changes in functional status by the Medical Outcomes Survey.

    Time frame: Baseline, 6-months post-Baseline

    Administer the Medical Outcomes Survey. Likert-type scale from 0=without help to 2=completely unable. Higher score signifies more limitations. No subscale.

  18. Measure association of p16 with changes in functional status with the Instrumental Activities of Daily Living Survey

    Time frame: Baseline, 6-months post-Baseline

    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.

  19. Measure association of p16 with changes in functional status with the Karnofsky Performance Status

    Time frame: Baseline, 6-months post-Baseline

    Administer the Karnofsky Performance Status

  20. Measure association of p16 with number of Fall Questionnaire

    Time frame: Baseline, 6-months post-Baseline

    One question will inquire about falls within the past 6 months.

  21. Measure association of p16 with limitations in walking one block

    Time frame: Baseline, 6-months post-Baseline

    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

Other outcomes

  1. Measure association of p16 with body composition

    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 and 12-months post-Baseline

    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.

  2. Mean change in p16 between baseline to end of chemo, compared to previous studies

    Time frame: Baseline, 6-months post-Baseline

    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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Dec 3, 2018
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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