Back to resultsTrial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer
Primary Purpose
Cancer Related Fatigue
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Related Fatigue focused on measuring Radiation therapy for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- women between the ages of 18 and 75 years
- histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive)
- radiation therapy naïve
- sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire
- ambulatory
- negative serum pregnancy test and not planning to become pregnant in the next three months
- able to provide meaningful consent.
- Patients must have been deemed by their medical oncologist or internist that they "may participate in [this] exercise trial." Prior to randomization, participants are required to complete a Physical Activity Readiness Questionnaire (PAR-Q) that includes questions regarding physical and medical conditions that would preclude safe participation in an exercise program.
Exclusion Criteria:
- younger than 18 or older than 75 years
- no histological confirmation of breast cancer
- prior breast, chest, or pelvic radiotherapy
- concurrent chemotherapy
- distant metastases
- physical limitations that contraindicate participation in low to moderate intensity exercise
- positive pregnancy test
- currently engaged in moderate to vigorous physical activity
- psychiatric disorder which would render the participant unable to provide informed consent.
Sites / Locations
- Hackensack University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Moderate Exercise
Control Group
Arm Description
Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week).
No exercise
Outcomes
Primary Outcome Measures
Assessment of change in fatigue via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) survey instrument.
The 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. The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability.
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%.
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%.
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%.
Complete blood count data (CBC)
We will collect CBC data at each blood draw for correlative and explorative purposes.
Secondary Outcome Measures
Assessment of change in Cancer-related healthcare quality of life (HRQOL) measured using the Functional Assessment of Cancer Therapy (FACT) system questionnaires.
The HRQOL measures four different domains (physical well-being, functional well-being, emotional well-being, and social/family well-being). 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.
Full Information
NCT ID
NCT02846389
First Posted
July 18, 2016
Last Updated
September 2, 2022
Sponsor
Hackensack Meridian Health
Collaborators
Lombardi Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02846389
Brief Title
Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer
Official Title
Randomized Controlled Trial of Exercise to Reduce Cancer Related Fatigue in Women Undergoing Radiation Treatment for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2016 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health
Collaborators
Lombardi Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Related Fatigue
Keywords
Radiation therapy for Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate Exercise
Arm Type
Experimental
Arm Description
Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No exercise
Intervention Type
Other
Intervention Name(s)
Moderate Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of change in fatigue via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) survey instrument.
Description
The 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. The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability.
Time Frame
Baseline, 4 weeks into RT, 4 week follow up visit
Title
Assessment of change in blood biomarker of inflammation: High sensitivity CRP (hsCRP)
Description
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%.
Time Frame
Baseline, 4 weeks into RT, 4 week follow up visit
Title
Assessment of change in blood biomarker of inflammation: Serum fibrinogen
Description
Fibrinogen will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%.
Time Frame
Baseline, 4 weeks into RT, 4 week follow up visit
Title
Assessment of change in blood biomarker of inflammation: Ferritin
Description
Ferritin will be measured using standardized clinical protocols. All assays have intra- and inter-assays coefficient of variations <10%.
Time Frame
Baseline, 4 weeks into RT, 4 week follow up visit
Title
Complete blood count data (CBC)
Description
We will collect CBC data at each blood draw for correlative and explorative purposes.
Time Frame
Baseline, 4 weeks into RT, 4 week follow up visit
Secondary Outcome Measure Information:
Title
Assessment of change in Cancer-related healthcare quality of life (HRQOL) measured using the Functional Assessment of Cancer Therapy (FACT) system questionnaires.
Description
The HRQOL measures four different domains (physical well-being, functional well-being, emotional well-being, and social/family well-being). 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.
Time Frame
Baseline, 4 weeks into RT, 4 week follow up visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women between the ages of 18 and 75 years
histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive)
radiation therapy naïve
sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire
ambulatory
negative serum pregnancy test and not planning to become pregnant in the next three months
able to provide meaningful consent.
Patients must have been deemed by their medical oncologist or internist that they "may participate in [this] exercise trial." Prior to randomization, participants are required to complete a Physical Activity Readiness Questionnaire (PAR-Q) that includes questions regarding physical and medical conditions that would preclude safe participation in an exercise program.
Exclusion Criteria:
younger than 18 or older than 75 years
no histological confirmation of breast cancer
prior breast, chest, or pelvic radiotherapy
concurrent chemotherapy
distant metastases
physical limitations that contraindicate participation in low to moderate intensity exercise
positive pregnancy test
currently engaged in moderate to vigorous physical activity
psychiatric disorder which would render the participant unable to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Lewis, M.D., Ph.D
Organizational Affiliation
Hackensack UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer
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