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Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Breast Cancer
Joint Pain

Treatments

Behavioral: Walk with Ease

Study type

Interventional

Funder types

Other

Identifiers

NCT01900418
13-2321

Details and patient eligibility

About

For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.

Enrollment

78 patients

Sex

Female

Ages

21 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks
  • Experiencing more than mild joint pain/symptoms
  • 21 or older
  • have permission from physician to engage in moderate intensity physical activity

Exclusion criteria

  • Undergoing chemotherapy and/or radiation therapy at any time during the study period
  • Scheduled for major surgery during the study period
  • Presently engaged in high levels of physical activity on a daily basis
  • Less than 21 years of age
  • Unable to walk or engage in moderate intensity physical activity

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

78 participants in 2 patient groups

Walking
Active Comparator group
Description:
Walk with Ease
Treatment:
Behavioral: Walk with Ease
Wait list control
No Intervention group
Description:
Wait list control receiving the active intervention 6 weeks later.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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