Health Education Intervention in Reducing Weight Gain in Patients With Newly Diagnosed Stage I-IV Breast Cancer Undergoing Chemotherapy

Completed · Not applicable

Conditions studied: Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

In brief

This pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer.

Key facts

Study ID

NCT01941784

Run by

Wake Forest University Health Sciences

People needed

28

Starts

2013-11-25

Expected to finish

2017-04-12

Last updated by the study team

2019-01-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds of chemotherapy
• 3.1.2 Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab. Participants must be within their first two rounds of chemotherapy - Body mass index (BMI) > 20
• Treating physician approval to participate in study
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

You may not qualify if…

• Diagnosis of recurrent breast cancer
• Women who are already participating in a formal or medically prescribed weight management program
• Women who have already completed more than two rounds of chemotherapy
• Women who are pregnant or nursing

Where it is running

• Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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