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Breast CancerEarly Phase 1EPPNASENCT02463383

Effect of PPARγ2 Polymorphism and NSAIDs on Acute Alcohol-induced Changes in Serum Estrogens Among Post-menopausal Women

A Early Phase 1 study testing Ibuprofen Tab 400 MG in people with Breast Cancer, run by Professor Lars Ove Dragsted at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2 (PPARG) polymorphism, were given the following treatments in a random order with a 5w wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed after 30min by a single acute dose of 0.4g alcohol… Read more about this study

Who is it for?
Ages 50 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Ibuprofen Tab 400 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteDenmark
Study dates
Sep 2013to Dec 2015
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 50 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • postmenopausal (last menses at least 1 year earlier);
  • having a weekly alcohol use of less than 14 drinks
  • having a BMI of 18-35;

Who cannot join

  • a history of alcohol abuse
  • alcohol abstaining
  • history of hysterectomy before last menses with preservation of both ovaries (unless a medical confirmation for the postmenopausal status exists or the participant is 60 years or older);
  • major health problems, such as ulcers, heart diseases, diabetes or cancer
  • previous or current use of HRT
  • taking prescription medications that could interfere with the study (i.e. daily use of NSAIDs and/or medication that interact with PPARγ e.g. cholesterol lowering medicine);
  • being allergic to alcohol and/or Ibuprofen
  • smoking

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Nutrition, Exercise and Sports, University of Copenhagen

    Frederiksberg, 1958

Other trials in Denmark

About this study

Official title: Alcohol-related Breast Cancer in Postmenopausal Women - Effect of PPARG2pro12ala Polymorphism on Female Sex-hormone Levels and Interaction With Alcohol Consumption and NSAID Usage

Postmenopausal women, stratified by a peroxisome proliferator-activated receptor gamma-2 (PPARG) polymorphism, were given the following treatments in a random order with a 5w wash-out period: a 400mg ibuprofen tablet or a placebo tablet; both treatments were followed after 30min by a single acute dose of 0.4g alcohol per kg bw. Serum estrogen levels were measured before and at three timepoints after alcohol intake. It is hypothesized that the acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is modulated by ibuprofen and by PPARG genotype.

Read the detailed description

In a pilot human intervention trial we aimed to determine the effect of the PPARG Pro12Ala polymorphism and the PPARγ stimulator, Ibuprofen, on sex-hormone levels following alcohol intake in postmenopausal women. Seven women with PPARG Pro12Ala and 18 PPARG wildtype women were included.The study was performed as a randomised, double-blinded, placebo controlled 2x24 h crossover study. The volunteers were randomised to 1 of 2 groups who got the two treatments in different orders. Treatment 1 was a placebo tablet with water followed after 30min by an alcoholic drink providing 0,4g alcohol per kilogram bw and treatment 2 was an Ibuprofen tablet (400mg) with water followed by the same alcoholic drink. The two treatments were separated by a 5-7 weeks washout period. Alcohol was supplied as 7.7% ethanol in a lime-flavoured drink and was consumed over 15 min. EDTA-plasma was collected 40min before and 30, 60 and 90 min after ethanol intake as well as after 24 hours. Ibuprofen (400mg) was provided together with 100mL water 30min before the ethanol. Urine was collected throughout the 24 hour interval. Serum estrone, estrone sulphate, serum estrogen-binding globulin (SHBG), and ethanol were determined. It is hypothesized that the acute decrease in estrogen sulphate and other markers of estrogens after alcohol intake is modulated by ibuprofen and by PPARG genotype.

Conditions
Breast Cancer
Being tested
Ibuprofen Tab 400 MG, Placebo tab
Keywords
PPAR-gamma, estrogens, NSAIDS, polymorphism, metabolomics
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ibuprofen Tab 400 MGDrug

    Also called (RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid

    400mg ibuprofen is provided and an alcohol challenge (0.4g/kg bw) is given 30min later

  • Placebo tabDrug

    Also called placebo tablet

    A placebo tablet is provided and an alcohol challenge (0.4g/kg bw) is given 30min later

Study groups in NCT02463383
Study groupRoleWhat they receive
Sequence 1Experimental1. Ibuprofen Tab 400MG 2. Placebo Tab
Receives: Drug: Ibuprofen Tab 400 MG; Drug: Placebo tab
Sequence 2Experimental1. Placebo tab 2. Ibuprofen Tab 400MG
Receives: Drug: Ibuprofen Tab 400 MG; Drug: Placebo tab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum estrone sulphate (pmol/l)

    Plasma estrone sulfate concentration after acute ethanol intake by Ibuprofen intake and/or PPARG genotype

    Measured: from 40 min before to 90 min after alcohol consumption

Secondary outcomes (5)

  1. Serum estrone (pmol/l)

    Plasma estrone decrease after acute ethanol intake by ibuprofen intake and/or PPARG genotype

    Measured: from 40 min before to 90 min after alcohol consumption

  2. Serum SHBG (nmol/l)

    Plasma SHBG concentration after acute ethanol ingestion by ibuprofen intake and/or PPARG genotype

    Measured: from 40 min before to 90 min after alcohol consumption

  3. Serum ethanol (g/l)

    Plasma ethanol concentration after acute ethanol ingestion

    Measured: from 40 min before to 90 min after alcohol consumption

  4. Serum metabolomics (relative metabolite intensity)

    The plasma metabolome profile by time after alcohol intake

    Measured: from 40 min before to 24h after alcohol intake

  5. Urine metabolomics (relative metabolite intensity)

    The urine metabolome profile by time after alcohol intake

    Measured: from 40 min before to 24h after alcohol intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionOct 2014
  4. Study completionDec 2015

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Participants are randomized to an ibuprofen or placebo pill in the first period and are then provided with placebo or ibuprofen pills, respectively, in the second period in a crossover fashion. Alcohol (0.4g/kg bw) is provided as a challenge 30min after the pill has been swallowed.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02463383
Sponsor's protocol ID
M215
Acronym
EPPNASE
Status last verified
Dec 2017
First submitted
17 May 2015
Last updated
12 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • Kopp TI, Jensen DM, Ravn-Haren G, Cohen A, Sommer HM, Dragsted LO, Tjonneland A, Hougaard DM, Vogel U. Alcohol-related breast cancer in postmenopausal women - effect of CYP19A1, PPARG and PPARGC1A polymorphisms on female sex-hormone levels and interaction with alcohol consumption and NSAID usage in a nested case-control study and a randomised controlled trial. BMC Cancer. 2016 Apr 21;16:283. doi: 10.1186/s12885-016-2317-y.

    PubMed 27102200

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ibuprofen Tab 400 MG in people with Breast Cancer, run by Professor Lars Ove Dragsted at 1 site in Denmark.

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 8 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 12 Dec 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 Denmark. 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.

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 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?

Serum estrone sulphate (pmol/l) (time frame: from 40 min before to 90 min after alcohol consumption). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02463383, which also lists 1 linked publication.

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 12 Dec 2017.

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