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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
  Purpose

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.


Condition Intervention
Breast Cancer
Weight Gain
 Procedure: Fasting blood sample.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Weight Fluctuation After Breast Cancer Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 250
Study Start Date: August 2008
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast cancer
Diagnosed with breast cancer 1/1/2003 - 31/12/2007.
 Procedure: Fasting blood sample.
Fasting blood sample taken following informed consent for genotyping, glucose and insulin levels.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991653

Sponsors and Collaborators
The Royal Bournemouth Hospital
Investigators
Principal Investigator: Tamas Hickish Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier: NCT00991653     History of Changes
Other Study ID Numbers: 08/H0201/35
Study First Received: October 6, 2009
Last Updated: December 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by The Royal Bournemouth Hospital:
Weight
Breast
Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Weight Gain
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013