The Effect of Walking on Fatigue During Radiotherapy in Breast Cancer Patients 65 and Older

Completed · Phase 2

Conditions studied: Breast Cancer, Fatigue

In brief

This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery. Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women in both arms will complete a number of surveys including questionnaires on fatigue, pain, depression, sleep, and social support. In addition, a blood sample will be collected prior to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of inflammatory biomarkers, and their potential association with exercise and fatigue.

Key facts

Study ID

NCT02434367

Run by

The West Clinic, Memphis

People needed

50

Starts

2014-08-01

Expected to finish

2017-06-30

Last updated by the study team

2017-12-14

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ≥65 years of age
• Histologically confirmed Stage I, II or III breast cancer status post breast surgery with or without adjuvant chemotherapy.
• Scheduled to undergo hypofractionated or standard fractionated radiation therapy to the breast or chest wall.
• English speaking.
• IRB approved, signed written informed consent.
• Approval from their treating radiation oncologist to engage in moderate-intensity physical activity. This will be obtained by the study research coordinator and documented on the study screening form (attached).
• 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.
• Receiving accelerated partial breast irradiation.
• Unable to walk or engage in moderate-intensity physical activity.
• Already participated in Walk with Ease Program.
• Already actively walking (≥120 minutes per week).

Where it is running

• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• The West Clinic/ University of Tennesee West Cancer Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.