Effects of a Structured Exercise Program on Cancer-Related Fatigue in Women Receiving Radiation Therapy for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      * Purpose of project (one or two sentences): The objective 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.

      2. * Study design (for example, hypothesis, research questions, standard and experimental
      procedures/drugs/devices or equipment, etc.):

      This is a randomized clinical trial to determine the efficacy of a structured,
      moderate-intensity aerobic exercise program in reducing cancer-related fatigue. The study
      occurs at a single-center setting. There are 30 breast cancer patient/subjects in all, a
      portion of whom (n=15) will undergo a structured, moderate-intensity aerobic exercise
      delivered via a stationary cycling device (peddlers).

      The study duration would be 12 months, and the administration of the study would be 8 weeks.
      The exercise program will be carried out at Washington Hospital Center while they wait for
      radiation therapy treatments.

      3. * Rationale and justification for study (i.e. historical background, investigator's
      personal experience, pertinent medical literature, etc.): Given the widespread use of RT for
      treatment of early stage breast cancers, and the identification of fatigue as an important
      side-effect of RT, it is important to test interventions that can reduce fatigue and improve
      the health-related quality of life (HRQOL) among survivors. PA interventions have been shown
      to improve quality of life and reduce fatigue in cancer patients undergoing RT. However, most
      studies on PA in RT-related fatigue and HRQOL have been conducted among Whites and evidence
      on the efficacy of PA interventions in African Americans is lacking. Additionally, the timing
      of introduction of PA with respect to the RT timeline is also unclear. Finally, although
      preliminary studies suggest that fatigue might be related to inflammation, it is not clear
      whether the effect of PA on fatigue is associated with changes in inflammatory biomarkers.
      The purpose of this study is to test the efficacy of a structured PA intervention in reducing
      cancer-related fatigue among African American patients undergoing RT for breast cancer.

      This study is also designed to provide pilot data on i) the acceptability of, and adherence
      with PA interventions in African Americans with breast cancer, and ii) the correlation of
      inflammation markers with fatigue and PA.

      4. * Primary objective: The purpose of this study is to test the efficacy of a structured PA
      intervention in reducing cancer-related fatigue among African American patients undergoing RT
      for breast cancer.

      5. * Secondary objectives: To determine the efficacy of a structured, moderate-intensity
      aerobic exercise program in improving HRQOL of African American patients undergoing RT for
      localized breast cancer.

      To determine the acceptability of, and adherence with a structured, exercise intervention
      among African-American patients undergoing RT for localized breast cancer.

      8.* Treatment Plan: 4.1 Randomization All participants (N=30) scheduled for radiotherapy will
      be randomized to one of the two following groups: i) a 8-week structured, moderate-intensity
      aerobic training exercise regimen concurrent with their radiation therapy (N=15), or ii)
      usual care control group (N=15). Participants will be randomized into the study by a
      bio-statistician once eligibility has been determined. All participants in the study will
      undergo radiation therapy as scheduled by their physicians. The exercise intervention will
      not interfere with either the dose or the timeline of their radiation therapy.

      4.2 PA intervention 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.

      9.* Primary Study Endpoint: The primary endpoints of the study are fatigue, HRQOL, and
      biomarkers of inflammation.
    

Intervention name(s): Physical Activity
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other