Effects of a Structured Exercise Program on Cancer-Related Fatigue in Women Receiving Radiation Therapy for Breast Cancer

NCT02117011 | Completed

• 1 other identifier: 2012-1377 Georgetown Lombardi
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation therapy (RT) is often used to treat breast cancer. RT combined with breast surgery is associated with better outcomes in early stage breast cancer compared to surgery alone. Fatigue is one of the most important side effects of RT because it can decrease patients' quality of life. Studies found that physical activity (PA) may help to improve quality of life in cancer survivors. PA has been reported to lower fatigue, anxiety, and depression. Physical inactivity over a long period of time may lead to rapid energy and physical function loss. PA intervention studies in patients undergoing RT have included mostly White patients. There is no evidence on African American patients undergoing RT. The purpose of this study is to examine the efficacy of a structured, moderate-intensity, aerobic exercise program in reducing cancer-related fatigue in African Americans undergoing RT for localized breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Reduce cancer-related fatigue

  Fatigue Cancer-related fatigue will be determined using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey instrument. The FACIT-Fatigue is a 13-item subscale developed to identify a finite set of concerns specific to fatigue. The responses to the 13 items on the FACIT fatigue questionnaire are each measured on a 4-point Likert scale. Thus, the total score ranges from 0 to 52. The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability.

  8 weeks

Secondary Outcomes (1)

• Increase quality of life

  8 weeks

Study Arms (2)

Physical activity

OTHER

An 8-week structured, moderate-intensity aerobic training exercise regimen concurrent with their radiation therapy (N=15),

Other: Physical Activity

Control

NO INTERVENTION

Patients will continue with usual care, which includes radiation treatment.

Interventions

Physical Activity OTHER

Those participants randomized to the exercise group will be required to exercise 5 days/week for 8 weeks coinciding with the radiation treatment sessions. The exercise intervention will consist of aerobic training. Participants will be required to meet and maintain a goal of 75 min/week of aerobic exercise by using portable cycle ergometers; that is; 15 min/day for 5 days/week. The cycle ergometer consists of two cycling pedals mounted to a stationary block that allows patients to exercise while sitting. The tension on the pedals can be adjusted to provide desired tension. Patients can also move the equipment so they can use it conveniently while sitting anywhere and with any chair.

Physical activity

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years old or less than 75 years old.
• histologically confirmed carcinoma of the breast
• radiation therapy naive
• sedentary, as defined as \<60 minutes of recreation or work requiring modest PA/week based on the 7 day physical activity recall questionnaire
• ambulatory
• negative serum pregnancy test and not planning to be pregnant in the next 3 months
• ability to understand and the willingness to sign a written informed consent.
• have breast cancer stage 0-IIIA
• completed neo-adjuvant or adjuvant chemotherapy may be concurrently receiving endocrine or HER2 directed therapy

You may not qualify if:

• age less than 18 years old or more than 75 years
• no histological confirmation of breast cancer
• prior breast, chest or pelvic radiotherapy
• concurrent chemotherapy
• distant metastases
• physical limitations (e.g., orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking program
• a positive pregnancy test, currently pregnant or planning to become pregnant in the next three months
• identified as the active or maintenance stage of exercise behavior
• psychiatric disorder which would render the subject unable to provide informed consent.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lucile Adams-Campbell

  Georgetown University

  PRINCIPAL INVESTIGATOR

• Pamela Randolph-Jackson

  Medstar Health Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 17, 2014
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2015
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (1)