Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
16/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jervoise Andreyev

ORCID ID

Contact details

Gastrointestinal Unit
Department of Medicine
Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0258171429

Study information

Scientific title

Acronym

Study hypothesis

Can a low fat diet (made up of 'normal' or 'long chain' fats) or a low fat diet containing additional 'medium chain' fats prevent or reduce bowel side effects in people undergoing a course of pelvic radiotherapy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

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 below to request a patient information sheet

Condition

Cancer: Pelvic radiotherapy

Intervention

Randomised test intervention vs no intervention controls, non-blinded (Phase III)

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

1. Bowel toxicity (assessed using IBD-Q) at week 4
2. Small bowel damage (citrulline/faecal calprotectin) at week 2 and week 4

Secondary outcome measures

Not provided at time of registration

Overall trial start date

03/01/2006

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who are about to undergo a course of radical or adjuvant pelvic radiotherapy for gynaecological, urological or lower gastrointestinal malignancy
2. Patients able to give informed consent to participate
3. Patients with healthy liver function

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

105

Participant exclusion criteria

1. Patients unable or unwilling to give informed consent
2. Patients who have already started radiotherapy
3. Patients who have a condition precluding sage oral nutrition
4. Patients with compromised liver function
5. Urology patients participating in the IMRT clinical trial.

Recruitment start date

03/01/2006

Recruitment end date

01/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gastrointestinal Unit
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The Royal Marsden NHS Foundation Trust (UK) - NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22515941

Publication citations

  1. Results

    Wedlake LJ, McGough C, Shaw C, Klopper T, Thomas K, Lalji A, Dearnaley DP, Blake P, Tait D, Khoo VS, Andreyev HJ, Clinical trial: Efficacy of a low or modified fat diet for the prevention of gastrointestinal toxicity in patients receiving radiotherapy treatment for pelvic malignancies., J Hum Nutr Diet, 2012, 25, 3, 247-259, doi: 10.1111/j.1365-277X.2012.01248.x.

Additional files

Editorial Notes