Condition category
Cancer
Date applied
20/09/2005
Date assigned
21/11/2005
Last edited
10/09/2012
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

Faculty of Medicine
Imperial College
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CCR2376

Study information

Scientific title

Acronym

Study hypothesis

To assess in adults with pelvic cancers and in adults without cancer:
1. The inter- and intra observer variation in acceptability of a range of nutritional supplements
2. Whether patients experience a change in taste during a course of radical radiotherapy
3. Whether there is a difference in taste between adults with pelvic malignancies and healthy controls

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

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Pelvic (gynaecological, urological or rectal) cancers

Intervention

Subjects were randomised to one of five groups. Each group was assigned a target quantity of 3 different elemental sip feeds (Group 1, 20%, Group 2, 50%, Group 3, 75% of calorie requirements taken as E028 extra liquid; Group 4, 50% of calorie requirements taken as E028 extra powder; Group 5, 50% of calorie requirements taken as Emsogen powder).

Intervention type

Supplement

Phase

Not Specified

Drug names

Elemental nutritional supplements

Primary outcome measures

Taste assessed by visual analogue scale

Secondary outcome measures

Not provided at time of registration

Overall trial start date

26/01/2004

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients about to embark on a course of radical pelvic radiotherapy for pelvic malignancy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Unwilling or unable to give informed consent to participate in the study
2. A clinical condition precluding oral feeding (e.g. dysphagia, bowel obstruction)
3. Unable to tolerate milk
4. Controls with a previous history of pelvic malignancy or currently receiving chemotherapy or radiotherapy

Recruitment start date

26/01/2004

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Faculty of Medicine
London
SW10 9NH
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Faculty of Medicine
Imperial College
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

SHS International

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dr Andreyev's Personal Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Marsden NHS Foundation Trust (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

2006 results on http://www.ncbi.nlm.nih.gov/pubmed/16289498

Publication citations

  1. Results

    McGough C, Baldwin C, Norman A, Frost G, Blake P, Tait D, Khoo V, Harrington K, Andreyev HJ, Is supplementation with elemental diet feasible in patients undergoing pelvic radiotherapy?, Clin Nutr, 2006, 25, 1, 109-116, doi: 10.1016/j.clnu.2005.09.007.

Additional files

Editorial Notes