Comparison of Nutrition Education Alone or With Acupuncture for Weight Loss in Breast Cancer Patients Post-Chemotherapy

Breast Cancer Clinical Trial

Official title:

Comparison of Weight Loss Among Early Stage Breast Cancer Patients Post Chemotherapy: Nutrition Education in Combination With Weight Loss Acupuncture Vs. Nutrition Education Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081612
• Other study ID #: GCO 14-0001
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 1, 2018

Study information

• Verified date: July 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy.

Description:

Obesity and weight gain are significant concerns for breast cancer survivors. Given the adverse consequences of weight gain after diagnosis, continued efforts to identify appropriate weight management interventions aimed at promoting overall health and long term survivorship are needed. In this study, the investigators will examine whether adding acupuncture to a nutrition education program for weight loss could improve short and long term weight loss among breast cancer survivors post treatment with chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 1, 2018
• Est. primary completion date: March 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Woman with a diagnosis of breast cancer, stage I, II, or III

• Age = 18

• ECOG performance status = 1

• Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.

• BMI = 30

• Adequate bone marrow and organ function as determined by the consenting/enrolling investigator

• Signed informed consent

• Any receptor status

• Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations

Exclusion Criteria:

• Current chemotherapy or radiation therapy. Participants in study may still be receiving hormone or Herceptin treatment.

• Diagnosis of metastatic breast cancer

• Participation in other diet-based weight loss programs (ie. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.)

• Current use of commercial or natural/herbal weight loss supplements

• Major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery

• Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin

• Personal history of an eating disorder

• Other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled HIV, Hepatitis B or C), or any psychiatric disorder that prohibits obtaining informed consent

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Weight Loss

Intervention

Behavioral:
• Nutrition Education
12 educational weight management group session each addressing a different weight loss topic

Procedure:
• Acupuncture
12 weight loss acupuncture session using both body and auricular points.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss		24 weeks
Secondary	Maintenance of weight loss		24 months
Secondary	Recurrence of breast cancer		5 years