Weight Fluctuation After Breast Cancer Treatment

NCT00991653 | Completed DMC

• 1 other identifier: 08/H0201/35
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Weight Gain

Keywords

Weight; Breast; Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Breast cancer

Diagnosed with breast cancer 1/1/2003 - 31/12/2007.

Procedure: Fasting blood sample.

Interventions

Fasting blood sample. PROCEDURE

Fasting blood sample taken following informed consent for genotyping, glucose and insulin levels.

Breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females over 18 years diagnosed with breast cancer between 1/1/2003 and 31/12/2007.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Fasting blood sample to determine participants genotype, insulin and glucose levels.

MeSH Terms

Conditions

Breast Neoplasms; Weight Gain; Body Weight; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tamas Hickish

  Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 8, 2009
• Study Start: August 1, 2008
• Primary Completion: January 1, 2013
• Last Updated: September 7, 2018

Record last verified: 2018-09