Weight Fluctuation After Breast Cancer Treatment

Completed

• Conditions: Breast Cancer; Weight Gain
• Interventions: Procedure: Fasting blood sample.

• Registration Number: NCT00991653
• Lead Sponsor: The Royal Bournemouth Hospital

Brief Summary

This study aims to identify and quantify the factors associated with excess weight gain following treatment for breast cancer. It is believed that breast cancer patients gain more than 4% of their weight at diagnosis which is likely accompanied by an increase in body fat and waist circumference. It is further thought that this excess weight and increase in body fat and waist circumference are associated to tumour characteristics, chemotherapy, menopause status at diagnosis and the presence of genes related to obesity. It is also thought that women treated with chemotherapy have higher levels of glucose and insulin.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Primary Completion: 2013-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• Females 18 years of age or older.
• Diagnosed with breast cancer between 1/1/2003 and 31/12/2007.
• Able to understand and willing to sign informed consent.

Exclusion Criteria

• Known diagnosis of previous breast/other cancer (other than completely resected non-melanoma skin cancer or successfully treated in situ cancer of the cervix.
• Known diagnosis of inflammatory bowel disease or malabsorption syndrome.
• Known diagnosis of endocrine problems associated with the development of obesity (cushings syndrome, hypo/hyperthyroid, thyroiditis)
• Treatment for psychiatric disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer	Fasting blood sample.	Diagnosed with breast cancer 1/1/2003 - 31/12/2007.

Primary Outcome Measures

Name	Time	Method
To provide evidence of the relationship between weight gain following diagnosis of breast cancer and tumour characteristics, chemotherapy, menopause status at diagnosis and the presence of genes related to obesity.	12-18 months.