Clinical trial NCT02434367: The Effect of Walking on Fatigue During Radiotherapy in Breast Cancer Patients 65 and Older
Official title: Phase 2 Randomized Study of a Walking Intervention for Radiation-related Fatigue Among Breast Cancer Patients Receiving Adjuvant Radiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Fatigue
Keywords: Cancer
Lead sponsor: The West Clinic, Memphis
Sponsor class: INDUSTRY
Collaborators: name: University of Tennessee West Cancer Center
First posted: 2015-05-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Recruitment, consent, and randomization will occur at first postoperative visit with a radiation oncologist. A 1:1 randomization will occur between WWE program and usual care (scripted discussion on benefit of exercise during radiotherapy). Prior to initiation of radiation, women in both arms will complete 68 questions from questionnaires on pain, depression, sleep, and social support. In addition, peripheral blood will be drawn for analysis of pre-radiation measures of inflammatory biomarkers. Women randomized to the WWE program will also receive a daily walking log that they will be asked to fill out and return on the last week of radiation (6 weeks for standard fractionation and 4.5 weeks for hypofractionation), and at 4-6 weeks post radiotherapy. Also, on their last week of radiotherapy and 4-6 weeks after radiotherapy all patients will repeat the questionnaires and a blood draw for measures of inflammatory biomarkers.

Contact with study participants will be at 3 points in time after enrollment and randomization:

Baseline: At this meeting, requirements of the study will be reviewed, and study materials provided (for control arm: a one page explanation discussing the potential benefits of exercise on fatigue, for experimental arm: WWE workbook, and printed walking log). Participants will complete questionnaires and undergo other assessments including a blood draw. For those on the experimental arm, they will be asked to begin the walking program within a week, noting their walking experience in their daily log.

Last week of radiation: All participants will repeat questionnaires and other assessments during any day of their last week of radiation. A repeat blood draw will be taken. In addition those on the WWE arm will have their walking log reviewed. For those receiving hypofractionated radiotherapy, this will occur at week 4. For those receiving standard fractionation this will occur at week 6.

4-6 weeks following end of radiation: All participants will repeat questionnaires and other assessments. A repeat blood draw will be taken. In addition those on the WWE arm will have their walking log reviewed.

Patients randomized to the usual care arm will receive a document with information on exercise to improve fatigue during radiotherapy. The sheet will summarize the findings of the 3 randomized studies on exercise intervention during radiotherapy.

The primary activity required of study subjects is a 4-6-week self-directed (non-group) WWE walking program that participants do at a place and time that is convenient for them. Participants are asked to walk at a safe and comfortable pace, increasing their minutes per day at a rate they can sustain, with the ultimate goal of 30 minutes/day for at least 5 days/week. They are asked to maintain a daily walking log that is provided to them, entering total minutes per day.

Eligibility criteria: Inclusion Criteria:

* ≥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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Compare the change in treatment related fatigue from baseline to last week of radiotherapy between patients in the WWE intervention and usual care arms using the Fatigue Symptom Index (FSI).
timeFrame: Four months
Secondary outcomes:
measure: Compare the change in treatment related fatigue from baseline to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms using the FSI.
timeFrame: Four months
measure: Change in Treatment Related Fatigue Symptom Index
timeFrame: Four months
measure: Change in Physical Funcionality Index
timeFrame: Four months
Other outcomes:
measure: Change in Pro-Inflammatory Cytokines
timeFrame: Four months
measure: Compare the change in fatigue-related side effects from baseline to last week of radiotherapy and to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms.
timeFrame: Four months
measure: Explore the association between the change in fatigue-related side effects from baseline to last week of radiotherapy and to 1-4 months post-radiotherapy with the change in fatigue at the same time-points.
timeFrame: Four months
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Memphis
country: United States
facility: The West Clinic/ University of Tennesee West Cancer Center
state: Tennessee
Study officials:
affiliation: The West Clinic/University of Tennessee West Cancer Center
name: Noam VanderWalde, MD
role: PRINCIPAL_INVESTIGATOR
References: