NCT02328313

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2019

Enrollment Period

4.3 years

First QC Date

October 21, 2014

Last Update Submit

April 29, 2020

Conditions

Breast CancerAgingPhysical Activity

Keywords

CancerBreast CancerGeriatricAdvance AgeExercisePhysical ActivityGenetic Markerp16ChemotherapyBreast Cancer Treatment

Outcome Measures

Primary Outcomes (2)

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

    The comparison group will be taken from another study

    12 months

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

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

    2 - 6 months

Secondary Outcomes (12)

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

    12 months

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

    12 months

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

    12 months

  • To measure change in physical activity over the course of the study

    12 months

  • To measure change in physical function over the course of the study

    12 months

  • +7 more secondary outcomes

Study Arms (1)

Intervention Cohort

EXPERIMENTAL

Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention.

Behavioral: Walk with Ease Program

Interventions

Walk with Ease ProgramBEHAVIORAL

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.

Intervention Cohort

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amy Garrett

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Nyrop KA, Page A, Deal AM, Wagoner C, Kelly EA, Kimmick GG, Copeland A, Speca J, Wood WA, Muss HB. Association of self-directed walking with toxicity moderation during chemotherapy for the treatment of early breast cancer. Support Care Cancer. 2023 Dec 28;32(1):68. doi: 10.1007/s00520-023-08275-4.

    PMID: 38153568DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor ActivityNeoplasms

Interventions

Walking

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Hyman Muss, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

December 31, 2014

Study Start

October 1, 2014

Primary Completion

January 16, 2019

Study Completion

January 16, 2019

Last Updated

April 30, 2020

Record last verified: 2019-04

Locations

US(1)