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Completed

NCT Number: NCT02328313

Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older

To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Amy Garrett

Chapel Hill, North Carolina, 27599, United States

About this study

LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 65 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 neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
  • 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

  • One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.

Treatment and study plan

Walk with Ease Program

Behavioral

The Walk With Ease Program sets a goal for participants to walk 30 minutes a day five times a week and gives helpful hints on how to achieve this goal.

Primary outcomes

  1. To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group

    Time frame: 12 months

    The comparison group will be taken from another study

  2. To measure the changes in the level of p16 expression from baseline and end of chemotherapy.

    Time frame: 2 - 6 months

    The study will look at the change of p16 expression within patients on this study.

Secondary outcomes

  1. To measure changes in body compositional aspects of lean body mass (LBM)

    Time frame: 12 months

    As measured by DEXA

  2. To measure changes in body compositional aspects of fat tissue mass (FM)

    Time frame: 12 months

    As measured by DEXA

  3. To measure changes in body compositional aspects of percentage body fat (BF)

    Time frame: 12 months

    As measured by DEXA

  4. To measure change in physical activity over the course of the study

    Time frame: 12 months

    As measured by engagement in walking survey

  5. To measure change in physical function over the course of the study

    Time frame: 12 months

    As measured by the Short Physical Performance Battery

  6. To measure change in fatigue over the course of the study

    Time frame: 12 months

    As measured by the FACIT-F

  7. To measure change in quality of life over the course of the study

    Time frame: 12 months

    As measured by the FACT-B

  8. To measure change in self-efficacy over the course of the study

    Time frame: 12 months

    As measured by the PSEFSM and OEE

  9. To measure retention during the study

    Time frame: 12 months

    • Retention will be assessed as the proportion of patients who enroll in the study who complete all questionnaires and assessments at all time points.

  10. To measure safety of the walking program

    Time frame: 12 months

    • Safety will be defined as any adverse events potentially related to the intervention, including falls, which are reported by study participants to the Study Team.

  11. To measure overall satisfaction with the program

    Time frame: 12 months

    As measured by a satisfaction questionnaire

  12. To average the number of daily and weekly steps per participant

    Time frame: 12 months

    As measure via an continuous accelerometer.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 31, 2014
Registry last updated
Apr 30, 2020

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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