Text Size

Weight Fluctuation After Breast Cancer Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT00991653
First received: October 6, 2009
Last updated: December 3, 2012
Last verified: December 2012
History of Changes

October 6, 2009
December 3, 2012
August 2008
January 2013   (final data collection date for primary outcome measure)
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. [ Time Frame: 12-18 months. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00991653 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Weight Fluctuation After Breast Cancer Treatment
Weight Fluctuation After Breast Cancer Treatment

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Fasting blood sample to determine participants genotype, insulin and glucose levels.
Non-Probability Sample

Females over 18 years diagnosed with breast cancer between 1/1/2003 and 31/12/2007.
  • Breast Cancer
  • Weight Gain
Procedure: Fasting blood sample.
Fasting blood sample taken following informed consent for genotyping, glucose and insulin levels.
Breast cancer
Diagnosed with breast cancer 1/1/2003 - 31/12/2007.
Intervention: Procedure: Fasting blood sample.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
Not Provided
January 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00991653
08/H0201/35
Yes
The Royal Bournemouth Hospital
The Royal Bournemouth Hospital
Not Provided
Principal Investigator: Tamas Hickish Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
The Royal Bournemouth Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP