StOIC (Study of Opioid-Induced Constipation) project - version 1.1

  • Research type

    Research Study

  • Full title

    An observational study of diagnostic criteria, clinical features and management of opioid-induced constipation in patients with cancer pain

  • IRAS ID

    222105

  • Contact name

    Andrew Davies

  • Contact email

    adavies12@nhs.net

  • Sponsor organisation

    Royal Surrey County Hospital NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 5 months, 31 days

  • Research summary

    Opioid-induced constipation (OIC) is constipation that occurs as a side effect of taking opioids, a major group of pain-relieving medication that includes codeine and morphine. It is a very common problem, especially in cancer patients. However, it is unclear just how common OIC is, as previous studies have not used consistent criteria to diagnose it.

    There are a number of treatments available to manage OIC, although it is not clear which ones should be used over others in cancer patients. A treatment plan based on current guidelines has been developed to help treatment decisions but its efficacy has not yet been tested.

    The objectives of this study are therefore:
    1. To determine exactly how common OIC is in people with cancer by using clear criteria for making the diagnosis.
    2. To determine how OIC impacts people with cancer.
    3. To investigate the efficacy of the treatment plan for OIC in people with cancer.

    The study is divided into two parts and will take place in hospitals, hospices and community healthcare settings. The first part (Study 1) consists of one visit. Participants are asked to complete a series of questionnaires and will be assessed by a palliative care specialist. Any adult cancer patient who has been taking opioid medication for cancer pain for at least one week is eligible to take part in Study 1. There will be 1000 participants.

    The second part (Study 2) will investigate the efficacy of the treatment plan for OIC. Participants from Study 1 identified as having OIC that is inadequately treated will be invited to take part. It will consist of four visits over four weeks. At each visit, participants will complete a short questionnaire and treatment alterations may be made based on the treatment plan. Participants will also complete a bowel diary throughout the study.

  • REC name

    East Midlands - Leicester Central Research Ethics Committee

  • REC reference

    17/EM/0212

  • Date of REC Opinion

    12 Jun 2017

  • REC opinion

    Further Information Favourable Opinion