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Trial record 84 of 3094 for:    Recruiting, Not yet recruiting, Available Studies | Physical

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

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ClinicalTrials.gov Identifier: NCT02328313
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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

Condition or disease Intervention/treatment Phase
Breast Cancer Aging Physical Activity Behavioral: Walk with Ease Program Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Intervention Cohort
Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention.
Behavioral: Walk with Ease Program
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328313


Contacts
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Contact: Kirsten Nyrop, PhD (919) 962-5139 kirsten_nyrop@med.unc.edu

Locations
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United States, North Carolina
Amy Garrett Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Amy Garrett, MA, CCRC    919-966-0695    amy_garrett@med.unc.edu   
Principal Investigator: Hyman B Muss, MD         
Sub-Investigator: William A Wood, MD         
Principal Investigator: Kirsten A Nyrop, PhD         
Sub-Investigator: Lisa A Carey, MD         
Sub-Investigator: E. Claire Dees, MD, MSc         
Sub-Investigator: Carey K Anders, MD         
Sub-Investigator: Katie Reeder-Hayes, MD         
Sub-Investigator: Trevor A Jolly, MD         
Sub-Investigator: Norman E Sharpless, MD         
Principal Investigator: Norman Sharpless, MD         
Principal Investigator: Claudio Battaglini, PhD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Hyman Muss, MD University of North Carolina

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02328313     History of Changes
Other Study ID Numbers: LCCC1410
14-2074 ( Other Identifier: UNC IRB )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Cancer
Breast Cancer
Geriatric
Advance Age
Exercise
Physical Activity
Genetic Marker
p16
Chemotherapy
Breast Cancer Treatment
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases