Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. This study is designed to gather more information, so that in the future, doctors can recommend whether patients should engage in exercise during a radiation treatment course.
Cancer related fatigue (CRF) is a common and debilitating side effect of radiotherapy in breast cancer patients. Physical activity interventions can attenuate CRF. The proposed study is a randomized, controlled trial (RCT) of exercise of structured moderate-intensity exercise intervention, delivered concurrently with radiotherapy, to reduce CRF and improve health-related quality of life among breast cancer patients. Eighty women with breast cancer scheduled to receive radiation therapy at Hackensack University Medical Center (HUMC) will be randomized to one of the two trial arms:1) a facility-based aerobic exercise utilizing a portable stationary pedal exerciser; or 2) a control group. Intervention arm participants will exercise at the hospital either before or after their radiation treatment. Assessments will be conducted at baseline, 4 weeks into radiation course, and at 4-week follow-up visit. The outcome variables are CRF, biomarkers of inflammation, and health-related quality of life (QOL). The study will provide preliminary evidence on whether a short-term moderate-intensity exercise intervention might be effective in reducing CRF in women undergoing radiotherapy for breast cancer, and whether this effect is mediated by inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Aerobic training utilizing the portable stationary pedal exerciser (Pedlar) which contains two cycling pedals mounted to a stationary block that allows patients to exercise while sitting. Participants are required to perform 15 minutes/day of aerobic exercise using the Pedlar device on radiation treatment days; during a standard radiation course, this will typically yield 75 minutes/week of aerobic time.
Hackensack University Medical Center
Hackensack, New Jersey, United States
Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument.
The Functional Assessment of Chronic Illness Therapy (FACIT) 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, with score ranging from 0 to 52 (52 being the total score allowed). The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability. Responses to questions are scored: Not at all (0), A little bit (1), Somewhat (2) Quite a bit (3), Very much (4). Some scores are reversed depending on the question. The sum of the item scores are multiplied by the number of items in the scale, then divide by the number of items answered. This produces the score. The higher the score, the better the QOL.
Time frame: Baseline, 4 weeks into RT
Assessment of Change in Blood Biomarker of Inflammation: High Sensitivity CRP (hsCRP)
Serum hsCRP will be measured on the Vitros 5,1 FS Chemistry platform via an immunoassay with a reportable range of 0.10 -15.00 mg/L, and intra- and inter-assay CVs of 1.8-4.0%. Change is reported based on the difference in the group mean of Serum hsCRP level between baseline and T4 visit.
Time frame: Baseline, 4 weeks into RT
Assessment of Change in Blood Biomarker of Inflammation: Serum Fibrinogen
Fibrinogen will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations \<10%. Change is reported based on the difference in the group mean of Serum fibrinogen level between baseline and T4 visit.
Time frame: Baseline, 4 weeks into RT
Assessment of Change in Blood Biomarker of Inflammation: Ferritin
Ferritin will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations \<10%. Change is reported based on the difference in the group mean of ferritin levels between baseline and T4 visit.
Time frame: Baseline, 4 weeks into RT
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Assessment of Change in Cancer-related Healthcare Quality of Life (HRQOL) Measured Using the Functional Assessment of Cancer Therapy (FACT) System Questionnaires.
The Health-related quality of life (HRQOL) measures four different domains (physical well-being, functional well-being, emotional well-being, and social/family well-being). Functional Assessment of Cancer Therapy (FACT-B) is a breast cancer specific module that will be used to reflect patients' concerns; moreover, they are reliable, reproducible, and have been validated in numerous studies. Score ranging from 0 to 148 (148 being the total score allowed). Responses to questions are scored: Not at all (0), A little bit (1), Somewhat (2) Quite a bit (3), Very much (4). Some scores are reveresed depending on the question. The sum of the item scores are multiplied by the number of items in the scale, then divide by the number of items answered. This produces the score. The higher the score, the better the QOL. Change in the group sum of the FACT score between baseline and T4 visit.
Time frame: Baseline, 4 weeks into RT