Assessment of the palatability of elemental nutritional supplements compared to non-elemental supplements in people with pelvic cancers and people without cancer, and whether this changes following treatment with radiotherapy

ISRCTN	ISRCTN35391431
DOI	https://doi.org/10.1186/ISRCTN35391431
Protocol serial number	CCR2376
Sponsor	Imperial College London (UK)
Funders	SHS International, Dr Andreyev's Personal Research Fund, Royal Marsden NHS Foundation Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jervoise Andreyev
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Taste assessed by visual analogue scale
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	Patients about to embark on a course of radical pelvic radiotherapy for pelvic malignancy
Key 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
Date of first enrolment	26/01/2004
Date of final enrolment	31/03/2006

Faculty of Medicine

London
SW10 9NH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2006		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes