Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/11/2013
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

Medicine Section
Royal Marsden NHS Trust
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
+44 (0)20 8643 8901

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0258134912

Study information

Scientific title

Acronym

ROBOTS 2 (Relief Of BOwel Toxicity Study 2)

Study hypothesis

This would be the first randomised trial addressing this issue in patients with bowel symptoms after 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

Condition

Injury, Occupational Diseases, Poisoning: Radiation injuries

Intervention

Patients will be randomised in a 2 x 2 factorial fashion to:
1. Pentoxifylline (trental)
2. High dose vitamins
3. Pentoxifylline (trental) with high dose vitamins
4. Placebo

Intervention type

Supplement

Phase

Not Specified

Drug names

Pentoxifylline (trental), high dose vitamins

Primary outcome measures

1. Changes in the bowel toxicity scale Inflammatory Bowel Disease Questionnaire (IBDQ)
2. Changes in the Vaizey incontinence questionnaire

Secondary outcome measures

Not provided at time of registration

Overall trial start date

26/03/2004

Overall trial end date

13/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients referred at least three months after pelvic radiotherapy
2. Patients must have gastrointestinal symptoms which were not present before radiotherapy
3. Must have undergone adequate gastroenterological assessment to reach a diagnosis
4. Must have residual gastrointestinal symptoms after three months of best therapy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Previous cerebrovascular haemorrhage
2. Previous retinal haemorrhage
3. Liver cirrhosis
4. Symptomatic coronary artery disease
5. Abnormal renal function and creatine clearance
6. History of renal tract stone
7. Evidence of recurrent disease

Recruitment start date

26/03/2004

Recruitment end date

13/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medicine Section
Sutton, Surrey
SM2 5PT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

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

Publication citations

Additional files

Editorial Notes