Background The development of oral cancer treatments (OCT) is sizeable, with many molecules in clinical trials. More and more patients wish to combine OCT to alternative therapy products (to reduce side effects, improve therapeutic effects). However, their use is associated with risks when combined with OCT: additional toxicities, drug interactions. Dispensing drugs included in clinical trials, the hospital pharmacist is responsible for their proper use, particularly the lack of interaction, with the help of documents supplied by the sponsor (investigator’s brochure, protocol and prescription forms).
Purpose The main objective of this study was to analyse information given by sponsors on the use of alternative therapy products in association with OCT in clinical trials.
Material and methods We did an inventory of all documents given by sponsors checking if the use of alternative therapy products were mentioned. They were recorded qualitatively and quantitatively, and their readability has been assessed as easy (<5 min), mild (5–10 min) or complex (>10 min).
Results The study was completed in our centre in May 2018, including 73 active trials with at least one OCT (61 OCT in monotherapy, 11 in bitherapy and one in tritherapy). Thirty-four trials (56%) in haematology, seven in onco-dermatology, the others for solid tumours. At least one information related to alternative therapy products was found in 57% of protocols, 14% of investigator’s brochure and 4% of prescription forms. Grapefruit was mentioned in 72% of documents, 76% for St. John’s Wort and 30% for bitter oranges. The other alternative therapy products were mentioned in less than 8% of documents. Only two protocols mention possible interaction with ‘herbal medicines products’. In more than 70% of cases, the information was easy to find. The protocol is the document where information was the most easily readable (92%).
Conclusion The key document to find information on alternative therapy products is the protocol, where information is easily readable. However, only grapefruit and St John’s Wort are mentioned in the main cases. In view of their rising uses, additional training should be offered to the pharmacist and a particular mention should be indicated on the prescription form, as a routine document, circulating between patient, doctor and pharmacist.
References and/or acknowledgements No conflict of interest.
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