The Muscle Mass, Omega-3, Diet, Exercise & Lifestyle (MODEL) Study: a nutrition program for women after breast cancer treatment

Not Applicable

• Conditions: Breast Cancer Survivors; Cancer - Breast

• Registration Number: ACTRN12610001005044
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

Breast cancer survivor. I.e. successfully completed surgery, radiotherapy and/or chemotherapy with no sign of existing disease.
Treatment was completed less than 12 months ago
Body Mass Index (BMI) of 20-35kg/m2
No pre-exisiting cardiovascular disease or diabetes

Exclusion Criteria

Metastatic disease.
BMI <20 or >35kg/m2
History of cardiovascular disease or diabetes
Physical limitation preventing light to moderate exercise
Mental illness or other inhibiting mental condition
Pregnancy
At discretion of medical oncologist

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in body composition- lean body mass and fat mass. Body composition will be measured primarily by air displacement plethysmography (ADP), the specific brand of the equipment is called the, BodPod. Additional measures will be a waist and hip circumference via tape measure, and bio-electrical impedance to determine lymphoedema status. Trained Dietitians will take all measurements.[Baseline, 12 weeks and 26 weeks]

Secondary Outcome Measures

Name	Time	Method
High sensitivity - C- reactive protein. Plasma assay of blood sample from each participant[Baseline, 12 weeks, 26 weeks];Quality of Life - Functional Assessment of Cancer Therapy - Breast plus 4 items for lymphoedema. (FACT-B+4)[Baseline, 12 weeks, 26 weeks]