Breast Cancer Clinical Trial
Official title:
A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients
Verified date | February 2010 |
Source | Fox Chase Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Physical activity may prevent or reduce weight gain in women receiving
chemotherapy for early stage breast cancer.
PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it
works compared with usual care to prevent or reduce weight gain in women with stage I or
stage II breast cancer undergoing chemotherapy.
Status | Completed |
Enrollment | 380 |
Est. completion date | |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Inclusion criteria: - Diagnosis of primary breast cancer - Newly diagnosed stage I or II disease - Receiving care at a participating Fox Chase Cancer Center CCOP Research Base (FCRB) member site - Geisinger Clinic and Medical Center (phase I) - Main Line Health (phase I) - Any of the other participating FCRB member sites (phase II) - Study intervention is scheduled to begin anytime after surgery up to 3 months after completion of adjuvant chemotherapy - Treatment plan includes adjuvant chemotherapy - Hormone receptor status not specified Exclusion criteria: - Treatment plan includes trastuzumab (Herceptin®) or bevacizumab - Recurrent breast cancer PATIENT CHARACTERISTICS: Inclusion criteria: - Female - Premenopausal or postmenopausal - Has obtained medical clearance by oncologist and breast surgeon to participate in this study - Body mass index = 20 kg/m^2 and < 39 kg/m^2 Exclusion criteria: - Hemoglobin < 12 g/dL - ANC < 1,500/mm^3 - Any medical condition that restricts participation in a physical activity program (e.g., exercise-induced angina, uncontrolled hypertension, dementia, or a major psychological problem) - Answers "yes" to any questions on the Physical Activity Readiness Questionnaire (PAR-Q) and PAR-Q not reviewed by a physician who subsequently approves participation in the physical activity intervention - Known to be pregnant or breastfeeding - Unwilling to commit or unable to participate in a 6-month physical activity intervention (unable to exercise, usually travels away from home overnight more than once per week, and/or has plans to be away from home for more than two weeks in the next 6 months) - Previously diagnosed with another primary cancer other than basal cell or squamous cell carcinoma of the skin - Exercising regularly prior to intervention (i.e., reports current participation in vigorous or moderate activity at least 3 days per week for at least 30 minutes each day on the International Physical Activity Questionnaire) - Unable to speak and read English PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No neoadjuvant chemotherapy |
Allocation: Randomized, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Fox Chase Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accrual (phase I) | No | ||
Primary | Retention (phase I) | No | ||
Primary | Weight change after 6 months (phase II) | No | ||
Secondary | Adiposity as measured by waist circumference at 3 and 6 months | No | ||
Secondary | Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales | No | ||
Secondary | Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale | No |
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 |