Trial of topical British Anti-Lewisite (BAL) to prevent cyclophosphamide induced alopeciae

ISRCTN	ISRCTN98865222
DOI	https://doi.org/10.1186/ISRCTN98865222
Secondary identifying numbers	BAL

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

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Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
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	Trial of topical British Anti-Lewisite (BAL) to prevent cyclophosphamide induced alopeciae
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Lung (non-small cell) cancer
Intervention	1. BAL Group: Chemotherapy, single-agent cyclophosphamide plus topical application of BAL. BAL lotion to be applied to posterior half of the scalp including occipital parietal areas two hours before and within 15 minutes of completing cyclophosphamide infusion. BAL to be left on the scalp for two to three hours. 2. Control Group: Chemotherapy, single-agent cyclophosphamide.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	British Anti-Lewisite, cyclophosphamide
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2000
Completion date	31/12/2003

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Lung cancer patients due to receive single-agent cyclophosphamide 2. Hair to be cut as short as possible before application of BAL
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2003

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

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