Cci pb gapp belgrad 22-04-2016

EU-projectPain treatment in childrenGAbapentin in Paediatric Pain (GAPP)

Patty Brouwer7th European CCI meeting, Belgrade

22 April 2016

Background: Why this study?

Suffering from (chronic) pain can limit a child’s ability to attend school, socialize and participate in physical activity.

Studies suggest that many children do not receive appropriate help or pain treatment, and are often undertreated(Goodman JE and McGrath PJ, 1991; Perquin CW et al., 2000; Schanberg LE et al., 2003).

Background: Why this study?Pain is one of the most frequent and serious symptoms experienced by patients in need of palliative care

80% of the world’s population lack adequate access to medication need for palliative care

Pain treatment in children

WHO guidelines on the pharmacological treatment of persisting pain in children with medical illnesses (including cancer), 2012:1. mild pain:

paracetamol/acetaminophen and ibuprofen (non opioids)

2. moderate to severe pain: morphine

WHO1st priority is to find strong opioids as an alternative for morphine or as a complimentary drug to morphine

2nd priority is the search for drugs to reduce neuropathic pain. Among these drugs, gabapentin is specifically listed.

GABAPENTIN• anti epileptic• used in adults for neuropathic pain

treatment• for adults proven to bring great

benefit, good results• expected to bring great benefit to

children for whom very few approved medication are available for the treatment of pain

Why is CCI involved?Pain is one of the most common symptoms in children with cancer.

About 40% of cancer-related pain is neuropathic pain.

A Parent’s Guide to Enhancing the Quality of Life in Children with Cancer, Chapter 4 Pain in Children with Cancer,2014 by Ruth I Hoffman MPH and Sandra E Smith

Why is CCI involved?Most of the included children in this trial will be oncology patients.

For many parents pain isone of the most concerning and frightening aspects of the journey.

One of CCI’s visions

CCI wants to ensure that children receive the best possible care (pain treatment) wherever they are in the world at the time of diagnosis and beyond

Final Goal of GAPPTo propose a treatment of chronic pain with a neuropathic component in children with gabapentin both as monotherapy and as additional therapy to morphine

To assess the safety of gabapentin in children

CCI’s participation in GAPP

Complicated trials• Children need to be woken up every 4 hours:

burden on child and parent during 17-21 weeks

• Large quantities of liquids of a nasty tasting substance

• Challenge to include enough children

• Possibly high withdrawal rates for inefficacy or adverse drug events

CCI’s participation in GAPP• Ethic committee:

Anouk Nijenhuis: CCI and VOKK

2 Study Protocols, Information Document, Annex on side effects of drugs, Consent form, Letter for the primary care doctor/paediatrician for informing the parents and patients.

CCI’s participation in GAPP• Scientific committee:

Marcela Zubieta: CCI board member

• Patient Advisory Board (PAB): to provide input with attention to patient perspective on GAPP project

Anouk Nijenhuis: CCI and VOKKPatty Brouwer: CCI and VOKK

GAPP Patient Advisory Board (PAB)The PAB aims to assess all relevant aspects of the GAPP project from the patient perspective, including patient information material for both GABA-1 (WP 7) and GABA-2 (WP 8) trials• Booklets: to help children to decide in

participation• Video: explanation of trials in general• Patient diary: children at home and record

pain scores

Focus Groups used for patients perspective

• Children 6-11 and 12-17 years old (<6 not included)

• 3 booklets for 3 age groups• 2 countries: Italy and the

Netherlands• Italy: children's hospital Padova• The Netherlands: pain department

Rotterdam and VOKK

Patient information bookletsFOCUS GROUP KEY QUESTIONS• General question on what each page

depicts• Specific questions regarding key

information– Purpose of study: well understood– Chronic vs. acute pain: in general well

understood but 9-11 struggled

Focus group key questions– Study stages and procedures:12-17: too busy, too much information

Focus group key questions– Disadvantages, possible side effects:

concept very clear, too many pages, disturbing drawings

Focus group key questions• Reasons to participate: well understood,

also that it might not help them• Withdrawal from study

Emphasize ability to withdraw at any time and how

• Privacy and consent Appreciate that data will be kept

private. Understand that only doctor and parents will know if a child participates.

Resulting revisions to booklets• 12-17 year old booklet– Change “Generation GAPP” in title

Overall conclusions• Patient information booklets clear and

enjoyable to read for the children

• Helpful minor revisions suggested

• Important themes identified for further discussion with treating physician:– Blood draws (frequency, how long)– Randomization, blinding, placebo– Urine test/pregnancy– Study withdrawal procedures

Next step• Including children in trials in:

AlbaniaEstoniaFranceGreece GermanyItalythe NetherlandsUnited Kingdom

• Hand out of information booklets

ContactsFor more information contact:

Coordinator: Dr. Donato Bonifazi of the Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) [email protected]

Patty [email protected]