Stage IIIA Breast Cancer Clinical Trial
Official title:
Can Aerobic and Strength Training Exercise Initiated During and Continued After Radiation Therapy for Breast Cancer Improve Fitness and Arm Health 1 Year Later?
Verified date | December 2023 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.
Status | Completed |
Enrollment | 4 |
Est. completion date | April 4, 2019 |
Est. primary completion date | April 4, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Stage II-III breast cancer - Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection - Prior chemotherapy in the neoadjuvant or adjuvant setting - Radiation plan consisting of regional nodal radiation - Must be suitable for an exercise program Exclusion Criteria: - Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician - Physical handicap that would prevent participation in program - Patients with metastatic breast cancer |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot) | determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. | Up to 1 year | |
Primary | Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II) | Will be compared to usual care group. | At 1 year | |
Secondary | Arm lymphedema as measured by arm circumference | Lymphedema will be classified into 3 stages. Stage I edema is reversible and characterized by pitting edema, increase in arm girth, and heaviness. Stage II is characterized by a spongy consistency of the arm without pitting edema. Stage III is the most advanced stage, lymphostatic elephantiasis | Baseline up to 1 year | |
Secondary | Arm range of motion as measured by goniometry | Shoulder flexion, external and internal rotation, and abduction will be measured. | Baseline up to 1 year | |
Secondary | Change in weight and BMI | BMI will be measured to evaluate body composition using the metric formula weight (kg)/ height 2 (m2). | Baseline up to 1 year | |
Secondary | Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs | Duration of exercise will be calculated based on questionnaire and exercise log. Percentage of exercise adherence at 1-year follow-up will be compared between two groups. Generalized linear models will be utilized to model follow-up as a function of baseline and group. | Baseline up to 1 year | |
Secondary | Percent increase in arm strength as measured by one repetition maximum | Change in strength from baseline to post-intervention and follow-up will be obtained. | Baseline up to 1 year | |
Secondary | Quality of life as measured by FACT-B+4 | The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales (0 - 4) for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms. | Baseline up to 1 year | |
Secondary | Subjective arm health as measured by FACT-B+4 | The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales (0 - 4) for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms. | Baseline up to 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02235051 -
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
|
N/A | |
Terminated |
NCT02454777 -
High-Intensity Interval Training for Stage I-III Breast Cancer Patients
|
N/A | |
Completed |
NCT03061175 -
Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
|
N/A | |
Completed |
NCT01959490 -
Trastuzumab and Pertuzumab or Bevacizumab With Combination Chemotherapy in Treating Patients With Stage II-III Breast Cancer
|
Phase 2 | |
Recruiting |
NCT03156309 -
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
|
Phase 1 | |
Completed |
NCT01928186 -
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
|
N/A | |
Terminated |
NCT01368263 -
Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer
|
Phase 2 | |
Terminated |
NCT01222377 -
Endoscopic Breast Surgery in Treating Patients With Breast Cancer
|
N/A | |
Completed |
NCT00425672 -
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
|
Phase 1/Phase 2 | |
Completed |
NCT00070252 -
Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02780401 -
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
|
Phase 1 | |
Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
Completed |
NCT01478477 -
Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole
|
N/A | |
Completed |
NCT03364348 -
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
|
Phase 1 | |
Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01672684 -
Phase I: At-Home Support for Rural Women Using Group Video Calling
|
Phase 1 | |
Withdrawn |
NCT01695057 -
Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer
|
N/A | |
Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT01234532 -
Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery
|
Phase 2 | |
Completed |
NCT00416715 -
Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
|
Phase 2 |