Weight Fluctuation After Breast Cancer Treatment

Breast Cancer Clinical Trial

Official title:

Weight Fluctuation After Breast Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991653
• Other study ID #: 08/H0201/35
• Status: Completed
• Start date: August 2008

Study information

• Verified date: September 2018
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Breast Cancer
• Breast Neoplasms
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.