A Double Blind, Randomised, Placebo Controlled Study of Farlutal in the Treatment of Weight Loss in Patients Undergoing Radiotherapy for Head and Neck Cancer

ISRCTN	ISRCTN72126158
DOI	https://doi.org/10.1186/ISRCTN72126158
Protocol serial number	MPA8801
Sponsor	Farmitalia Carlo Erba (Italy)
Funder	Not provided at time of registration.

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Head and Neck Cancer
Intervention	1. Group A: Oral medroxyprogesterone acetate 500 mg twice daily for a maximum of 12 weeks 2. Group B: Placebo tablets twice daily for a maximum of 12 weeks
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	19/08/2005

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Key inclusion criteria	1. Aged >18 years 2. Squamous cell carcinoma of the head and neck 3. Not known to have or suspected of having early breast cancer 4. No known hypersensitivity to medroxyprogesterone acetate 5. No medical contraindications to treatment
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	19/08/2000
Date of final enrolment	19/08/2005

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

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