Purified fatty acids for endometriosis clinical trial

ISRCTN	ISRCTN44202346
DOI	https://doi.org/10.1186/ISRCTN44202346
Clinical Trials Information System (CTIS)	2013-004938-15
Protocol serial number	Version 4
Sponsor	University of Edinburgh and NHS Lothian
Funder	University Of Edinburgh

Submission date: 01/05/2017
Registration date: 30/05/2017
Last edited: 14/06/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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)

Contact information

Mrs Ann Doust
Public

University of Edinburgh
51 Little France Crescent
Edinburgh Eh16 4SA
Edinburgh
EH16 4SA
United Kingdom

Phone	+44 (0)131 242 9492
Email	ann.doust@ed.ac.uk

Prof Andrew Horne
Scientific

QMRI
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled double-blind feasibility study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	PurFECT: PURified Fatty acids for Endometriosis Clinical Trial: a randomised controlled trial
Study acronym	PurFECT
Study objectives	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(s)	South East Scotland Research Ethics Committee 01, 02/02/2016, ref: 16/SS/0010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	01/03/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Female
Target sample size at registration	40
Total final enrolment	33
Key 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
Key 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
Date of first enrolment	30/06/2016
Date of final enrolment	31/12/2017

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Royal Infirmary of Edinburgh

51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/01/2020	20/01/2020	Yes	No
Protocol article	protocol	01/12/2018		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 2.0	25/01/2016	14/06/2023	No	No

Additional files

ISRCTN44202346_Protocol_v2.0_25January2016.pdf: Protocol file

Editorial Notes

14/06/2023: Uploaded protocol (not peer reviewed).
20/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
30/04/2018: Publication reference added.
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.