EPIVIN trial (v 1.0)
Research type
Research Study
Full title
Phase II clinical trial investigating the use of epigallocatechin-3-gallate (Veregen) in the treatment of vulval intraepithelial neoplasia
IRAS ID
135235
Contact name
David Luesley
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2013-003107-19
ISRCTN Number
na
Clinicaltrials.gov Identifier
na
Research summary
In recent years, there has been more than a three-fold increase in the number of young women diagnosed with “pre-cancerous” changes in their vulva. These changes which are also known as vulval intraepithelial neoplasia or VIN, are almost always associated with pain or persistent itching. While surgery is still the mainstay of treatment which aims both to relieve symptoms and to prevent progression to cancer, it is often ineffective because VIN frequently reoccurs at more than one site. To reduce the number of women having repeated surgery which may itself cause additional physical and psychosexual problems, new medical treatments are needed.
Research has shown that a compound found in green tea can “switch on” genes which are silenced in cancer. Clinical studies have shown that this compound (Veregen) is a safe and effective treatment for vulval warts which are caused by a virus called human papillomavirus (HPV); certain strains of this virus also cause VIN and vulval cancer. This drug has also been shown to prevent the progression of precancerous changes in the mouth, another disease associated with HPV infection. We believe that Veregen could relieve both the symptoms experienced by women with VIN and reduce their risk of progressing to cancer. A multidisciplinary team of clinicians, statisticians and scientists will investigate in an “early phase trial” how well these women tolerate Veregen and whether it causes their pre-cancerous changes to disappear. The trial will be performed in a specialist vulva clinic at City Hospital, Birmingham. 56 patients will be randomly allocated to receive Veregen or a placebo ointment. Whether or not we decide to explore the use of this treatment further in a larger study will depend on how often pre cancerous changes are found to have resolved in a biopsy taken 32 weeks after the start of treatment.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0398
Date of REC Opinion
20 Dec 2013
REC opinion
Further Information Favourable Opinion