Breast CancerNCT00991653
Weight Fluctuation After Breast Cancer Treatment
An observational study of Breast Cancer and Weight Gain, run by The Royal Bournemouth Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Weight Gain
- What is being tested?
- Fasting blood sample.
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females over 18 years diagnosed with breast cancer between 1/1/2003 and 31/12/2007.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Fasting blood sample.
- Keywords
- Weight, Breast, Cancer
- Medical subject headings
- Breast Neoplasms, Weight Gain, Body Weight, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting blood sample.Procedure or surgery
Fasting blood sample taken following informed consent for genotyping, glucose and insulin levels.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Diagnosed with breast cancer 1/1/2003 - 31/12/2007. Receives: Procedure: Fasting blood sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startAug 2008
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamas Hickish, Principal investigator, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991653
- Sponsor's protocol ID
- 08/H0201/35
- Status last verified
- Sep 2018
- First submitted
- 6 Oct 2009
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Fluctuation After Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT00991653
- Acronym / sponsor ID
- 08/H0201/35
- Conditions
- Breast Cancer, Weight Gain
- Keywords
- Weight, Breast, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jan 2013 (actual)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | Procedure: Fasting blood sample.Diagnosed with breast cancer 1/1/2003 - 31/12/2007. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females over 18 years diagnosed with breast cancer between 1/1/2003 and 31/12/2007.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting blood sample.Fasting blood sample taken following informed consent for genotyping, glucose and insulin levels. | Procedure or surgery | Breast cancer |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamas Hickish principal investigator
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Weight Gain, run by The Royal Bournemouth Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.