Condition category
Urological and Genital Diseases
Date applied
01/05/2017
Date assigned
30/05/2017
Last edited
01/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Endometriosis is a common condition where tissue that behaves like the lining of the womb (endometrium) is found in other parts of the body. It affects 6-10% of women and causes severe pelvic pain. Endometriosis can be treated surgically or medically. However, symptoms often come back after surgery and the currently available medical treatments are hormones which have undesirable side effects and are contraceptive. Omega-3 purified fatty acid (PUFA) supplements may reduce endometriosis-associated pain, have minimal side effects and no effects on fertility. The aim of this small study is to assess the feasibility of conducting a larger study of PUFA for endometriosis-associated pain.

Who can participate?
Patients aged 18-50 with endometriosis

What does the study involve?
Participants are randomly allocated to receive soft gelatin capsules containing either omega-3 purified fatty acids (fish oil) or olive oil, and are advised to take two capsules per day, one in the morning and one in the evening for 8 weeks. Pain is measured at the start and end of the study and blood samples are collected to measure fatty acid levels.

What are the possible benefits and risks of participating?
PUFAs are a dietary supplement and may reduce endometriosis-associated pain. They have minimal side effects and no effects on fertility.

Where is the study run from?
Royal Infirmary of Edinburgh (UK)

When is the study starting and how long is it expected to run for?
October 2013 to May 2017

Who is funding the study?
University of Edinburgh (UK)

Who is the main contact?
1. Mrs Ann Doust (public)
ann.doust@ed.ac.uk
2. Prof. Andrew Horne (scientific)

Trial website

Contact information

Type

Public

Primary contact

Mrs Ann Doust

ORCID ID

Contact details

University of Edinburgh
51 Little France Crescent
Edinburgh Eh16 4SA
Edinburgh
EH16 4SA
United Kingdom
+44 (0)131 242 9492
ann.doust@ed.ac.uk

Type

Scientific

Additional contact

Prof Andrew Horne

ORCID ID

Contact details

QMRI
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Additional identifiers

EudraCT number

2013-004938-15

ClinicalTrials.gov number

Protocol/serial number

Version 4

Study information

Scientific title

PurFECT: PURified Fatty acids for Endometriosis Clinical Trial: a randomised controlled trial

Acronym

PurFECT

Study hypothesis

Endometriosis (womb lining outside the womb) affects 6-10% of women and is associated with debilitating chronic pelvic pain. It costs the UK >£2.8 billion per year in loss of productivity. Endometriosis is managed surgically or medically. However, ~75% symptoms recur after surgery and available medical treatments (‘anti-hormones’) have undesirable side effects and are contraceptive. Omega-3 purified fatty acids (PUFA) have been shown in animal models to reduce factors that are thought to lead to endometriosis-associated pain, have minimal side effects and no effects on fertility. The trialists plan to perform a feasibility study to inform planning of a future multicentre trial to evaluate the efficacy of PUFA in the management of endometriosis-associated pain.

Ethics approval

South East Scotland Research Ethics Committee 01, 02/02/2016, ref: 16/SS/0010

Study design

Randomised controlled double-blind feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Endometriosis-related pain

Intervention

Participants are randomised to receive either omega-3 purified fatty acids (fish oil) or olive oil soft gelatin (placebo) capsules, with a dose of 1000 mg each, and advised to take two capsules per day, one in the morning and one in the evening for 8 weeks. The outcomes are measured at baseline and at the end of the study (i.e., 8 weeks).

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. The proportion of screened women who are eligible for the trial
2. The proportion of eligible patients randomised into the study
3. The proportion of randomised patients who take the supplement and complete questionnaires at final follow up

The outcomes will be measured at baseline and at the end of the study (i.e., 8 weeks).

Secondary outcome measures

The remaining outcomes will be used to refine the research methodology of a future large RCT:
1. Pain, measured using the Numerical Rating Score (NRS) collected via text message during the screening phase (-1 to -4 weeks) and last 4 weeks (weeks 5-8) of the treatment phase
2. Eicosapentaenoic acid, arachidonic acid and docosahexaenoic acid concentrations measured from peripheral venous blood samples at baseline and 8 weeks
3. Quality of life, measured using SF-12 at baseline and 8 weeks
4. Pain, measured using the Brief Pain Inventory (BPI) at baseline and 8 weeks
5. Pain catastrophizing, measured using the Pain Catastrophising Questionnaire (PCQ) at baseline and 8 weeks
5. Pain, measures using the PainDETECT™ questionnaire at baseline and 8 weeks
6. Sexual activity, measured using the Sexual Activity Questionnaire (SAQ) at baseline and 8 weeks
7. Fatigue, measured using the Brief Fatigue Inventory (BFI) at baseline and 8 weeks
8. General health, measures using the General Health Questionnaire -12 (GHQ-12) at baseline and 8 weeks
9. Work and productivity activity impairment, measured using the Work and Productivity Activity Impairment Questionnaire- Specific Health Problem version 2.0 (WPAI-SHP) at baseline and 8 weeks
10. Acceptability of proposed methods of recruitment, randomisation, treatments and questionnaires, measured using a questionnaire at 8 weeks

Overall trial start date

28/10/2013

Overall trial end date

01/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18-50 years
2. Known endometriosis diagnosed from previous laparoscopy
3. Pain of at least 3 months duration located in the true pelvis
4. Worst pain score ≥4 over 4 weeks as measured by Numerical Rating Score (NRS)
5. Ability to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Unable to take/allergic to fish/PUFA/peanuts/soyabean
2. Insulin dependent diabetes
3. Pregnant
4. Taking contraindicated medications (anticoagulants)
5. Breastfeeding

Recruitment start date

30/06/2016

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Sponsor information

Organisation

University of Edinburgh and NHS Lothian

Sponsor details

ACCORD Office
QMRI
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Of Edinburgh

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The target is to use the clinical study report for publication and presentation at scientific meetings.

IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/05/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/09/2017: The overall trial end date was changed from 01/05/2017 to 01/03/2018. Recruitment end date changed from 21/03/2017 to 31/12/2017.