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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2006 results on http://www.ncbi.nlm.nih.gov/pubmed/16289498
Publication citations
-
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.