Rx for Better Breast Health

Breast Cancer Clinical Trial

Official title:

Prescription for Better Breast Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279303
• Other study ID #: HSC20140150H
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: January 18, 2018
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI] and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group.

Description:

The investigators will recruit English-speaking, early-stage breast cancer survivors (N=200) to a two-arm randomized controlled trial (RCT) involving a 2 (group) by 3 (time) repeated measures design. The intervention will stimulate dietary behavior changes using individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Groups will be compared at baseline and 6- and 12-month follow-up. Dependent measures will include dietary behavior and levels of cancer-associated biomarkers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females 18 years or older

• Primary diagnosis of breast cancer

• Fluency in English

• B.M.I. >= 30

• Available for follow-up for 12 months

Exclusion Criteria:

• Clinical evidence of metastatic disease

• Not diagnosed with primary breast cancer

• Lack fluency in English

• B.M.I. < 30

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Dietary Intervention
Participants will receive individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change.
• Dietary Control
Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieve USDA-recommended dietary intake based on five major food groups	The USDA has published dietary intake guidelines for 5 major food groups. We will create a composite score ("yes" vs. "no") describing whether ss achieve designated levels of dietary intake for all five food groups. We will compare proportions of study and control women achieving this target at 12-month follow-up controlling for baseline values.	12 months
Primary	Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up	We will compare participant (intervention) versus control levels of circulating Adipose Stromal Cells (ASCs) at 12-month follow-up. Participant levels of ASCs will be significantly lower than controls, controlling for baseline values.	12 months
Primary	Comparison of Interleukin (IL) pro-inflammatory biomarkers	We will compare participant versus control levels of Interleukins IL3, IL6, IL8 at 12-month follow-up. Participant levels of IL3, IL6, and IL8 will be significantly lower than controls, controlling for baseline values.	12 months
Primary	Comparison of Interleukin (IL) anti-inflammatory biomarkers	We will compare participant versus control levels of Interleukin IL10 at 12-month follow-up. Participant levels of IL10 will be significantly lower than controls, controlling for baseline values.	12 months
Primary	Comparison of C-Reactive Protein (CRP)	We will compare participant versus control levels of C-Reactive Protein (CRP) at 12-month follow-up. Participant levels of CRP will be significantly lower than controls, controlling for baseline values.	12 months
Primary	Comparison of Tumor Necrosis Factor-alpha (TNF-alpha)	We will compare participant versus control levels of Tumor Necrosis Factor-alpha (TNF-alpha) at 12-month follow-up. Participant levels of TNF-alpha will be significantly lower than controls, controlling for baseline values.	12 months