Breast Cancer Clinical Trial
— WWEOfficial title:
Phase 2 Randomized Study of a Walking Intervention for Radiation-related Fatigue Among Breast Cancer Patients Receiving Adjuvant Radiation
Verified date | November 2016 |
Source | The West Clinic, Memphis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the
Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to
usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery.
Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women
in both arms will complete a number of surveys including questionnaires on fatigue, pain,
depression, sleep, and social support. In addition, a blood sample will be collected prior
to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of
inflammatory biomarkers, and their potential association with exercise and fatigue.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - =65 years of age - Histologically confirmed Stage I, II or III breast cancer status post breast surgery with or without adjuvant chemotherapy. - Scheduled to undergo hypofractionated or standard fractionated radiation therapy to the breast or chest wall. - English speaking. - IRB approved, signed written informed consent. - Approval from their treating radiation oncologist to engage in moderate-intensity physical activity. This will be obtained by the study research coordinator and documented on the study screening form (attached). - Patient-assessed ability to walk and engage in moderate physical activity Willing and able to meet all study requirements. Exclusion Criteria: - One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention. - Receiving accelerated partial breast irradiation. - Unable to walk or engage in moderate-intensity physical activity. - Already participated in Walk with Ease Program. - Already actively walking (=120 minutes per week). |
Country | Name | City | State |
---|---|---|---|
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | The West Clinic/ University of Tennesee West Cancer Center | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
The West Clinic, Memphis | University of Tennessee West Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Pro-Inflammatory Cytokines | Explore the association between pro-inflammatory cytokines (TNF-a, IL-1ß, and IL-6) at baseline, last week of radiation, and 1-4 months after radiation and changes in fatigue and exercise during those time periods. We will assess both the association of cycle. | Four months | |
Other | Compare the change in fatigue-related side effects from baseline to last week of radiotherapy and to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms. | change in fatigue index | Four months | |
Other | Explore the association between the change in fatigue-related side effects from baseline to last week of radiotherapy and to 1-4 months post-radiotherapy with the change in fatigue at the same time-points. | change in fatigue index | Four months | |
Primary | Compare the change in treatment related fatigue from baseline to last week of radiotherapy between patients in the WWE intervention and usual care arms using the Fatigue Symptom Index (FSI). | change in fatigue index | Four months | |
Secondary | Compare the change in treatment related fatigue from baseline to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms using the FSI. | change in fatigue index | Four months | |
Secondary | Change in Treatment Related Fatigue Symptom Index | Compare the change in treatment related fatigue from baseline to last week of radiotherapy and to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms using the PROMIS Fatigue 8a scale. | Four months | |
Secondary | Change in Physical Funcionality Index | Compare the change in physical functionality from baseline to last week of radiotherapy and to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms using the Short Physical Performance Battery and PROMIS Short Form v1.0 | Four months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
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
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
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 |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |