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
Secondary identifying numbers	CCR2376

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	Taste assessed by visual analogue scale
Secondary outcome measures	Not provided at time of registration
Overall study start date	26/01/2004
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Imperial College London (UK)
University/education

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

"ROR"	https://ror.org/041kmwe10

Industry

SHS International

No information available

Dr Andreyev's Personal Research Fund

No information available

Royal Marsden NHS Foundation Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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