Breast CancerNCT01237938
Effect of a Low Glycemic Index Diet on Breast Density
A study testing Low Glycemic Diet in people with Breast Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Low Glycemic Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2008
- Phase
- Interventional
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Are between 40 and 60 years of age
- Still menstruating with at least 10 menstrual cycles in the previous 12 months
- Not Taking hormone replacement therapy
- Stable oral contraceptive use (no changes is use in past 12 months nor changes intended during interventional period)
- Have not been previously diagnosed with breast cancer, DCIS,lobular carcinoma in situ, atypical lobular hyperplasia or atypical hyperplasia
- No history of breast augmentation or reduction surgery
Show all 12Show fewer
- Have no history of any other malignancy (excluding non-melanoma skin cancer) in the previous 5 years
- Have no history of diabetes or other metabolic diseases requiring dietary modification
- Have a study baseline mammographic density of at least 50% as estimated by mammographer
- BIRADS 1 or 2 mammogram if first ever mammogram, otherwise stable mammogram (no change since previous year)
- Have not followed a weight reduction or Atkins typs diet in the past 6 months Not pregnant or lactating in the past 12 months, nor intending pregnancy during the study period
- Successful completion of three baseline telephone-administered 24- hour dietary recalls
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Pilot Study of the Effect of a Low Glycemic Index Diet on Breast Density (Diet and Breast Health Study )
This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Low Glycemic Diet
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycemic DietBehavioural
Changing to low glycemic diet
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Diet | Experimental | Not described Receives: Behavioral: Low Glycemic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Change
To Assess the feasibility of a randomized trial to achieve diet change and promote longterm adoption of a low glycemic index diet intervention among women at high risk for breast cancer (> 50% of breast area occupied by radiological density)
Measured: 2 years
Secondary outcomes (1)
Biomarkers
To estimate the effect of a low glycemic index diet on breast cancer related biomarkers, including those associated with carbohydrate, growth and steroid hormaone metabolism and mammograhic density. Result from this aim will provide important preliminary data for use in planning a larger clinical trial.
Measured: 4, 8 & 12 months on Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startMar 2006
- Primary completionOct 2008
Why it stopped: test
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.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan McCann, PhD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237938
- Sponsor's protocol ID
- I 71005
- Status last verified
- Apr 2014
- First submitted
- 8 Nov 2010
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of a Low Glycemic Index Diet on Breast Density (Diet and Breast Health Study )
- ClinicalTrials.gov ID
- NCT01237938
- Acronym / sponsor ID
- I 71005
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: test
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Oct 2008 (actual)
- First posted
- 10 Nov 2010 (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 is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Diet | Experimental | Behavioral: Low Glycemic Diet |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Are between 40 and 60 years of age
- Still menstruating with at least 10 menstrual cycles in the previous 12 months
- Not Taking hormone replacement therapy
- Stable oral contraceptive use (no changes is use in past 12 months nor changes intended during interventional period)
- Have not been previously diagnosed with breast cancer, DCIS,lobular carcinoma in situ, atypical lobular hyperplasia or atypical hyperplasia
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Low Glycemic DietChanging to low glycemic diet | Behavioural | Low Glycemic Diet |
Primary outcome
Diet Change
Time frame: 2 years
To Assess the feasibility of a randomized trial to achieve diet change and promote longterm adoption of a low glycemic index diet intervention among women at high risk for breast cancer (> 50% of breast area occupied by radiological density)
1 secondary outcome
Biomarkers
Time frame: 4, 8 & 12 months on Treatment
Results and safety
The study was stopped early (reason given: test). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
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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.
Susan McCann, PhD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Diet in people with Breast Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
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 12 inclusion and 0 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: stopped early, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: test). Results are not available in the source record.
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?
Diet Change (time frame: 2 years). 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 3 Apr 2014.