Breast Cancer Clinical Trial
Official title:
Effects of a Structured Exercise Program on Cancer-Related Fatigue in Women Receiving Radiation Therapy for Breast Cancer
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.
* 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |