PEPtalk 2: Pilot of a randomised controlled trial to compare VZIG and aciclovir as post-exposure prophylaxis against chickenpox in children with cancer

ISRCTN	ISRCTN48257441
DOI	https://doi.org/10.1186/ISRCTN48257441
EudraCT/CTIS number	2013-001332-22
Secondary identifying numbers	15060

Submission date: 08/11/2013
Registration date: 08/11/2013
Last edited: 22/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-vzig-or-aciclovir-for-children-who-have-been-exposed-to-chicken-pox-during-cancer-treatment-peptalk2

Contact information

Mr Stephen Baker
Scientific

Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies, Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	peptalk2@trials.bham.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	PEPtalk 2: Pilot of a randomised controlled trial to compare VZIG and aciclovir as post-exposure prophylaxis against chickenpox in children with cancer
Study acronym	PEPtalk 2
Study objectives	Treatment for cancer in children often includes the use of anti-cancer drugs called chemotherapy. Some chemotherapy drugs can reduce the production of white blood cells, which lowers a child's immunity. This means that some infections that are usually mild in healthy children can be more difficult for a child with cancer to cope with. Chickenpox is one of these infections and it can be life-threatening for a child with cancer. It is therefore important to try to prevent children with cancer from developing chickenpox. If a child with cancer has close contact with someone who is infectious for chickenpox, they are usually offered preventative medicine. This is called post-exposure prophylaxis (PEP). There are two different types of PEP used in the UK and medical opinion is divided over which is better. So about half of children receive VZIG, an injection of chickenpox antibodies into the muscle, while the other half of children receive aciclovir, an orally administered course of antiviral medicine. This pilot trial aims to prepare for a main Phase III trial, the aim of which will be to find out whether aciclovir is at least as good as VZIG in protecting against chickenpox in children with cancer. This pilot study will help to inform a sample size calculation; it will test the components of the larger study; and it will test how acceptable the trial procedures are to parents, patients and clinicians. A secondary aim is to establish whether these two treatments have different costs to the health service and the effects on patients quality of life. A health economic analysis will be performed accordingly.
Ethics approval(s)	13/LO/0551; First MREC approval date 14/05/2013
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network, Medicines for Children Research Network; Subtopic: All Cancers/Misc Sites, All Diagnoses; Disease: All, All Diseases
Intervention	Trial Treatment, Both trial arms are 'standard' treatments although which is the standard varies from one centre to another. Some patients may therefore receive an intramuscular injection, by way of the trial treatment, in circumstances where they would more commonly receive oral therapy, and vice versa. The potential risks and discomfort associated with both therapies are explained in the Parent/Patient Information Sheets and clinicians will also explain these to parents and (where possible) patients when takin
Intervention type	Other
Primary outcome measure	The number of patients randomised within 12 months of the trial
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2014
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	16 Years
Sex	Both
Target number of participants	Planned Sample Size: 50; UK Sample Size: 50
Key inclusion criteria	For registration: 1. Under 16 years of age 2. EITHER diagnosed with cancer such that there is a standard expectation of immunocompromising therapy OR currently receiving immunocompromising treatment for cancer OR within 3 months of having received immunocompromising treatment for cancer 3. No current or previous allogeneic or autologous haemopoietic stem cell transplantation / rescue 4. Negative VZV serostatus result at cancer diagnosis or negative VZV serostatus result within the last 3 months as assessed locally 5. Written informed consent to registration received from parent/legal representative and, where appropriate, written patient assent For randomisation: 1. Patient has previously been registered in the PEPtalk2 trial, having satisfied all registration requirements 2. Registration criterion (c) continues to apply 3. Immunocompromising treatment for cancer must have been initiated prior to VZV exposure 4. Patient is able to commence either VZIG no more than 10 days after experiencing VZV exposure, or aciclovir at 7 days after experiencing VZV exposure (see sections 5.1.2 and 5.1.3) 5. No renal impairment. Renal impairment is expressed in terms of glomerular filtration rate (ml/min/1.73m2). Child over 1 year: Estimated glomerular filtration rate (ml/min/1.73m2) = 40 x height (cm) x serum creatinine (micromol/litre). Normal renal function: > or equal to 90ml/min/1.73m2 6. Written informed consent to randomisation received from parent/legal representative and, where appropriate, written patient assent Important note regarding thrombocytopenia: platelets must be > 50 x 109/L to receive an intramuscular injection of VZIG. Therefore, if a child is randomised to receive VZIG and platelets are found to be < 50 x 109/L no more than 48 hours prior to VZIG administration, arrangements must be made by local staff to administer a platelet transfusion prior to VZIG injection. There are no criteria for platelet count if randomised to acyclovir.
Key exclusion criteria	Exclusion from Registration: 1. 16 years of age or over 2. Current or previous allogeneic or autologous haemopoietic stem cell transplant/rescue 3. Positive VZV serostatus result as assessed locally within the last 3 months Note: renal impairment and thrombocytopenia are not absolute contraindications for registration as they might resolve by the time a chickenpox exposure and screening for randomisation occur Exclusion from randomisation: 1. Positive VZV serostatus result at time of screening 2. Contraindication to either aciclovir or VZIG, including: 2.1. thrombocytopenia (platelets < 50 x 109/L) that has not been corrected by platelet transfusion 2.2. renal impairment (exclude any child with GFR below 90ml/min/1.73m2) 2.3. any other contraindications deemed to be relevant by the local Investigator or the Sponsors Clinical Coordinator(s) 3. Inability to start either VZIG within 10 days of VZV exposure, or acyclovir at 7 days after VZV exposure 4. More than one VZV exposure within the past 12 weeks 5. Inability to tolerate medications via oral or enteral route 6. Pregnancy or lactation
Date of first enrolment	01/01/2014
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cancer Research UK Clinical Trials Unit

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Birmingham Clinical Trials Unit
Division of Cancer Studies
Robert Aitken Institute
, Edgbaston
Birmingham
B15 2TT
England
United Kingdom

"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

Research for Patient Benefit Programme
Government organisation / National government

Alternative name(s): NIHR Research for Patient Benefit Programme, RfPB
Location: United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2019	22/01/2019	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

22/01/2019: Publication reference added
12/01/2018: No publications found, verifying study status with principal investigator.