Breast Cancer Clinical Trial
Official title:
Obesity Reduction Black Intervention Trial (ORBIT)
Verified date | March 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: A diet and physical activity program followed by a weight-loss maintenance
program may help obese black women lose weight. It is not yet known whether a weight-loss
program is more effective than a general health education program in helping obese black
women lose weight. Weight loss may reduce a person's risk of developing cancer.
PURPOSE: This randomized phase III trial is studying a weight-loss program to see how well
it works in helping obese black women lose weight.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 50 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Self-identified as Black or African-American - Body mass index = 30 kg/m² PATIENT CHARACTERISTICS: - Pre- or perimenopausal - Not pregnant or nursing - Not planning to become pregnant - Not planning to move from the Chicago area during the active and maintenance study interventions (18 months) - No exercise intolerance due to chronic obstructive pulmonary disease (e.g., emphysema, chronic bronchitis, or exercise-induced asthma) - No cancer requiring treatment within the past 5 years, except nonmelanoma skin cancer - No diabetes - No uncontrolled hypertension - Participants on hypertensive medication may be eligible upon approval by the Investigator - None of the following conditions: - Unstable angina - Orthostatic hypotension - Moderate to severe aortic stenosis - Uncontrolled arrhythmia - Uncontrolled congestive heart failure - Pulmonary embolism within the past 6 months - History of cardiac arrest - No significant mental illness (e.g., schizophrenia or unmedicated bipolar disorder) - No alcohol intake of > 2 drinks per day - No illegal drug use - No laxative abuse (i.e., > twice the recommended dose) PRIOR CONCURRENT THERAPY: - No concurrent treatment for an eating disorder - No concurrent medications (e.g., hormone-replacement therapy) that could interfere with adherence to an exercise program or could interfere with study outcomes - No concurrent participation in a formal weight-loss program - No concurrent pharmacotherapy for weight loss |
Allocation: Randomized
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois Cancer Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body mass index as assessed at baseline, 24 weeks, and 18 months | No | ||
Primary | Changes in glucose, insulin, and IGF levels as assessed at baseline, 24 weeks, and 18 months | No | ||
Secondary | Changes in diet and physical activity as assessed by Block 98 FFQ and Stanford 7-Day Physical Activity Recall questionnaires at baseline, 24 weeks, and 18 months | No | ||
Secondary | Changes in knowledge, attitudes, self-efficacy, and social support related to diet, physical activity, and weight loss as assessed by Nutrition Attitudes Scale, Self-Efficacy for Eating and Exercise Behaviors, and Social Support for Eating and Exerci ... | No |
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 |
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 |