Breast CancerEarly Phase 1NCT01784042
Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue
A Early Phase 1 study testing Lovaza and Dietary energy restriction in people with Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The over-reaching goal of this study is to test the merit of combining dietary energy restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention strategy in overweight and obese women at high risk. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lovaza and Dietary energy restriction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2018
- Phase
- Early Phase 1
- 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 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Five year predicted breast cancer risk of at least 1.66%.
- Prior breast biopsy showing atypical ductal or lobular hyperplasia or lobular carcinoma in situ or ductal carcinoma in situ (DCIS).
- Known breast cancer-1 and -2 mutations.
- Breast density >50% as assessed by the conventional two-dimensional method.
Who cannot join
- Weight loss of 10 pounds in past six months.
- History of fish allergy.
- Oral contraceptives or hormone replacement therapy in the past 6 months.
- Pregnancy or lactation in the last 12 months or planning to become pregnant in the next 12 months.
- Current smoking.
- Diagnosis of cancer except basal cell carcinoma of the skin or lobular carcinoma in situ or DCIS.
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- Diagnosis of type 1 or type 2 diabetes based on standard criteria, irrespective of treatment.
- Recent stroke or cardiovascular event.
- History of eating disorders documented in medical records.
- History of major gastrointestinal disease impairing absorption.
- History of bariatric surgery.
- Recent, current or planned use of diet drugs as per patient history.
- Participants must not use flaxseed oil supplements during study participation.
- Participants must not use Omega-3 preparations while participating on this trial.
- Participants must not use Tamoxifen or Raloxifene during study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Effect of Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue and Systemic Biomarkers of Breast Cancer Risk
The over-reaching goal of this study is to test the merit of combining dietary energy restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention strategy in overweight and obese women at high risk.
Read the detailed description
Obesity over the pre- and postmenopausal years is linked to the risk of postmenopausal breast cancer. Multiple mechanisms are likely to contribute to obesity associated breast cancer risk. They include increased insulin like growth factor (IGF)-I bioavailability, oxidative stress, raised leptin to adiponectin ratio, and increased inflammatory cytokines which are responsible for the creation of a systemic and local hyperestrogenic milieu by induction of aromatase and may also be responsible for the reduction in antitumor immunity by stimulation of immunosuppressive cells. While derivative chromosome disulfiram (DER) has been shown to reverse some of these obesity related phenotypic features, it is not yet established whether DER reduces breast cancer risk using validated tissue biomarkers predictive of breast cancer development. N:3FA (3-fatty acids) have been shown to ameliorate obesity-induced effects on circulating leptin and adiponectin, insulin resistance, endogenous estrogen production and inflammation. Although preclinical studies have indicated a protective effect of n:3FA on mammary carcinogenesis, the data in humans are inconclusive, likely as a result of the lack of controlled clinical trials. Investigators hypothesize that the combination of DER and n:3FA will reduce breast cancer risk in an additive/synergistic fashion through their complementary effects on the multiple inter-related pathways accounting for the obesity associated breast cancer risk. Investigators propose to conduct a clinical trial study involving overweight and obese women between the ages of 30 and 55 who are at high risk of breast cancer and are found on random periareolar fine needle aspiration to have hyperplasia with or without atypia with Ki67 ≥2 if premenopausal and ≥1.5 if postmenopausal. Following stratification according to menopausal status they will be randomized to one of four experimental groups.
- Conditions
- Breast Cancer
- Being tested
- Placebo, Lovaza, Dietary energy restriction
- Keywords
- breast cancer, omega-3 fatty acids
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo
LovazaDrug
Also called Lovaza (omega-3-acid ethyl esters)
Dietary energy restrictionOther
| Study group | Role | What they receive |
|---|---|---|
| No dietary energy restriction plus Placebo | Placebo comparator | No dietary energy restriction plus Placebo Receives: Drug: Placebo |
| Dietary energy restriction plus placebo | Placebo comparator | Dietary energy restriction plus placebo Receives: Drug: Placebo; Other: Dietary energy restriction |
| Lovaza | Experimental | Lovaza only Receives: Drug: Lovaza |
| Dietary energy restriction plus Lovaza | Experimental | Dietary energy restriction plus Lovaza Receives: Drug: Lovaza; Other: Dietary energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki67 expression
Ki67 expression by hyperplastic breast lesions
Measured: about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: No funding
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 Milton S. Hershey Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Manni, Milton S. Hershey Medical Center
- Investigators
- Andrea Manni, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784042
- Sponsor's protocol ID
- PSHCI 12-075
- Status last verified
- May 2017
- First submitted
- 31 Jan 2013
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue and Systemic Biomarkers of Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT01784042
- Acronym / sponsor ID
- PSHCI 12-075
- Conditions
- Breast Cancer
- Keywords
- breast cancer, omega-3 fatty acids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 5 Feb 2013 (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.
The over-reaching goal of this study is to test the merit of combining dietary energy restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention strategy in overweight and obese women at high risk.
Detailed description
Obesity over the pre- and postmenopausal years is linked to the risk of postmenopausal breast cancer. Multiple mechanisms are likely to contribute to obesity associated breast cancer risk. They include increased insulin like growth factor (IGF)-I bioavailability, oxidative stress, raised leptin to adiponectin ratio, and increased inflammatory cytokines which are responsible for the creation of a systemic and local hyperestrogenic milieu by induction of aromatase and may also be responsible for the reduction in antitumor immunity by stimulation of immunosuppressive cells. While derivative chromosome disulfiram (DER) has been shown to reverse some of these obesity related phenotypic features, it is not yet established whether DER reduces breast cancer risk using validated tissue biomarkers predictive of breast cancer development. N:3FA (3-fatty acids) have been shown to ameliorate obesity-induced effects on circulating leptin and adiponectin, insulin resistance, endogenous estrogen production and inflammation. Although preclinical studies have indicated a protective effect of n:3FA on mammary carcinogenesis, the data in humans are inconclusive, likely as a result of the lack of controlled clinical trials. Investigators hypothesize that the combination of DER and n:3FA will reduce breast cancer risk in an additive/synergistic fashion through their complementary effects on the multiple inter-related pathways accounting for the obesity associated breast cancer risk. Investigators propose to conduct a clinical trial study involving overweight and obese women between the ages of 30 and 55 who are at high risk of breast cancer and are found on random periareolar fine needle aspiration to have hyperplasia with or without atypia with Ki67 ≥2 if premenopausal and ≥1.5 if postmenopausal. Following stratification according to menopausal status they will be randomized to one of four experimental groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No dietary energy restriction plus Placebo | Placebo comparator | Drug: PlaceboNo dietary energy restriction plus Placebo |
| Dietary energy restriction plus placebo | Placebo comparator | Drug: Placebo, Other: Dietary energy restrictionDietary energy restriction plus placebo |
| Lovaza | Experimental | Drug: LovazaLovaza only |
| Dietary energy restriction plus Lovaza | Experimental | Drug: Lovaza, Other: Dietary energy restrictionDietary energy restriction plus Lovaza |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Five year predicted breast cancer risk of at least 1.66%.
- Prior breast biopsy showing atypical ductal or lobular hyperplasia or lobular carcinoma in situ or ductal carcinoma in situ (DCIS).
- Known breast cancer-1 and -2 mutations.
- Breast density >50% as assessed by the conventional two-dimensional method.
Key exclusion criteria (15 listed)
- Weight loss of 10 pounds in past six months.
- History of fish allergy.
- Oral contraceptives or hormone replacement therapy in the past 6 months.
- Pregnancy or lactation in the last 12 months or planning to become pregnant in the next 12 months.
- Current smoking.
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 |
|---|---|---|
| Placeboplacebo | Drug | Dietary energy restriction plus placebo, No dietary energy restriction plus Placebo |
| LovazaAlso: Lovaza (omega-3-acid ethyl esters) | Drug | Dietary energy restriction plus Lovaza, Lovaza |
| Dietary energy restriction | Other | Dietary energy restriction plus Lovaza, Dietary energy restriction plus placebo |
Primary outcome
Ki67 expression
Time frame: about 1 year
Ki67 expression by hyperplastic breast lesions
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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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.
Andrea Manni, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lovaza and Dietary energy restriction in people with Breast Cancer, run by Milton S. Hershey Medical Center 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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 9 May 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Ki67 expression (time frame: about 1 year). 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 9 May 2017.