Breast CancerNCT02117011
Effects of a Structured Exercise Program on Cancer-Related Fatigue in Women Receiving Radiation Therapy for Breast Cancer
A study testing Physical Activity in people with Breast Cancer, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20057
About this study
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.
Read the 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.
- * 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.
- * 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.
- * 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.
- * 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.
- Conditions
- Breast Cancer
- Being tested
- Physical Activity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Other | An 8-week structured, moderate-intensity aerobic training exercise regimen concurrent with their radiation therapy (N=15), Receives: Other: Physical Activity |
| Control | No intervention | Patients will continue with usual care, which includes radiation treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
Increase quality of life
HRQOL Cancer related HRQOL among participants in the study will be measured using the Functional Assessment of Cancer Therapy (FACT) system questionnaires.
The Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire is one of the most widely used HRQOL instruments. It measures HRQOL in four different domains (Physical well-being, Functional well-being, Emotional well-being and Social/Family well-being). To this core questionnaire, we will add specific modules specific for breast (FACT-B) cancer. Thus, the FACT B questionnaire contains an additional series of questions specific to FACT-B some specific questions about breast cancer (37). The FACT system has a number of advantages as a method of measuring HRQOL. The questionnaires have been developed to reflect patients' concerns; moreover they are reliable, reproducible and have been validated in numerous studies. Higher scores on the FACT questionnaires reflect higher QOL.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucile Adams-Campbell, Principal investigator, Georgetown UniversityPamela Randolph-Jackson, Study director, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117011
- Sponsor's protocol ID
- 2012-1377 Georgetown Lombardi
- Status last verified
- Jan 2020
- First submitted
- 26 Mar 2014
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Structured Exercise Program on Cancer-Related Fatigue in Women Receiving Radiation Therapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02117011
- Acronym / sponsor ID
- 2012-1377 Georgetown Lombardi
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- * 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.
- * 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.
- * 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.
- * 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Other | Other: Physical ActivityAn 8-week structured, moderate-intensity aerobic training exercise regimen concurrent with their radiation therapy (N=15), |
| Control | No intervention | –Patients will continue with usual care, which includes radiation treatment. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- -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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityThose 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. | Other | Physical activity |
Primary outcome
Reduce cancer-related fatigue
Time frame: 8 weeks
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.
1 secondary outcome
Increase quality of life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucile Adams-Campbell principal investigator
Georgetown University
Pamela Randolph-Jackson study director
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Breast Cancer, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce cancer-related fatigue (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.