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

NCT02434367 | Completed Phase 2

• 1 other identifier: LCCC 1412
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Fatigue

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  change in fatigue index

  Four months

Secondary Outcomes (3)

• 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.

  Four months

• Change in Treatment Related Fatigue Symptom Index

  Four months

• Change in Physical Funcionality Index

  Four months

Other Outcomes (3)

• Change in Pro-Inflammatory Cytokines

  Four months

• 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.

  Four months

• 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.

  Four months

Study Arms (2)

Arm A

EXPERIMENTAL

Women randomized to the WWE program will receive a workbook, and a daily walking log, the latter to be completed during the study.

Behavioral: Walk With Ease Arm A

Arm B

NO INTERVENTION

Patients randomized to the usual care arm will receive a document with information on exercise to improve fatigue during radiotherapy

Interventions

Walk With Ease Arm A BEHAVIORAL

Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The interention is a self directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes per day, five days per week.

Also known as: WWE

Arm A

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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).

Sponsors & Collaborators

• The West Clinic, Memphis: lead
• University of Tennessee West Cancer Center: collaborator

Study Sites (2)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

The West Clinic/ University of Tennesee West Cancer Center

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Neoplasms

Interventions

Walking

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Noam VanderWalde, MD

  The West Clinic/University of Tennessee West Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 5, 2015
• Study Start: August 1, 2014
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: December 14, 2017

Record last verified: 2016-11

Locations

US (2)