The Hemospray™ Study

  • Research type

    Research Study

  • Full title

    The “Hemospray™ study: a role for treating radiation-induced recto-sigmoid bleeding?”

  • IRAS ID

    157557

  • Contact name

    Jervoise Andreyev

  • Contact email

    jervoise.andreyev@rmh.nhs.uk

  • Sponsor organisation

    The Royal Marsden NHS Foundation Trust

  • Duration of Study in the UK

    0 years, 11 months, 26 days

  • Research summary

    The aim of the study is to evaluate the efficacy of a new agent called “Hemospray”TM in the long term treatment for radiation induced bleeding.

    Rectal bleeding following radiotherapy to a tumour in the pelvis occurs in approximately 50% of all people treated. In most people, the bleeding is trivial and occasional. However, approximately one in 20 patients will develop significant bleeding, for example having bleeding which regularly or intermittently soaks their clothes, or occurs sufficiently frequently or is so heavy that it interferes with daily activity, or makes them anaemic or causes them to become dependent on blood transfusions or require treatment with iron supplements.

    At the Royal Marsden Hospital, when people develop such troublesome bleeding after radiotherapy we discuss the pros and cons of up to four different treatments with them. None of the current treatments are ideal. Current treatments include long term, daily or twice daily therapy with enemas, treatment with formalin placed into the bottom, treatment with argon plasma coagulation (a sort of laser) or hyperbaric (high pressure) oxygen therapy. All these treatments may help reduce bleeding from the rectum, however, all these treatments are complicated, have potential risks and can cause a variety of side effects. None of the current available treatments for radiotherapy-induced bleeding are totally safe or ideal and none have been properly evaluated in clinical trials.

    In view of this, there is a requirement for new, more effective and safer therapies. Hemospray™ is a potential new treatment for rectal bleeding induced by radiotherapy and we would like to test whether it in fact works.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    14/LO/1789

  • Date of REC Opinion

    2 Dec 2014

  • REC opinion

    Further Information Favourable Opinion