Weight Fluctuation After Breast Cancer Treatment
September 5, 2018 updated by: The Royal Bournemouth Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
250
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Females over 18 years diagnosed with breast cancer between 1/1/2003 and 31/12/2007.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast cancer
Diagnosed with breast cancer 1/1/2003 - 31/12/2007.
|
Fasting blood sample taken following informed consent for genotyping, glucose and insulin levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
12-18 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tamas Hickish, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
October 6, 2009
First Submitted That Met QC Criteria
October 7, 2009
First Posted (Estimate)
October 8, 2009
Study Record Updates
Last Update Posted (Actual)
September 7, 2018
Last Update Submitted That Met QC Criteria
September 5, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/H0201/35
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.