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Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain

Primary Purpose

Ulcer, Wounds and Injuries

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
topical morphine
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcer focused on measuring Skin ulcers, Topical morphine, Chronic pain, Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Moderate to severe resting pain (scores above 5/10). Stable analgesic regimen. No surgical interventions planned during the study period. Able to self-assess pain and report it. Hospitalized or receiving home care for Stage I; out-patients or receiving home care for Stage II. Wound not infected or covered with necrotic tissue. Exclusion Criteria: True sensitivity to opioids

Sites / Locations

    Outcomes

    Primary Outcome Measures

    pain intensity reports
    frequency and type of side effects
    blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide

    Secondary Outcome Measures

    quantification of wound healing
    change in use of regular analgesics

    Full Information

    First Posted
    March 21, 2006
    Last Updated
    July 3, 2012
    Sponsor
    Soroka University Medical Center
    Collaborators
    Israel Cancer Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00306020
    Brief Title
    Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain
    Official Title
    Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was withdrawn due to difficulties in recruiting appropriate patients in community clinic setting
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Soroka University Medical Center
    Collaborators
    Israel Cancer Association

    4. Oversight

    5. Study Description

    Brief Summary
    Cutaneous cancer-related pain is difficult to treat. These patients are often prescribed high systemic dosages of opioids. Yet, many patients continue to report pain while experiencing dose-limiting side effects. An alternative approach to systemic administration is to apply topical medications. The advantage of topical application is the potential of achieving good analgesia using low dosages with few, if any, systemic side effects. Current clinical data indicates, that topically applied morphine has an analgesic effect in patients with severe pain and that it may even improve wound healing. The clinical reports so far have been either case studies or double blind randomly controlled trials with a very small sample size of patients. There is still a great deal of information which is lacking about this modality of treatment regarding on the one hand, the mechanism of action and on the other, clinical issues. For example, is the mechanism of the effect actually peripheral? What is the adequate dose of analgesic medication for different types of skin conditions? Wound healing has not been quantified. We will apply morphine topically to skin wounds of cancer and evaluate the effect of the treatment on pain, side effects, quantify wound healing, quantify morphine and its metabolites in blood and urine. Should well controlled studies, demonstrate all or any of the peripheral effects of topical morphine, clinical application of this treatment modality would be possible. This could contribute towards better treatment of these patients, who have pain which is difficult to treat and can, at times, be intractable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcer, Wounds and Injuries
    Keywords
    Skin ulcers, Topical morphine, Chronic pain, Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    topical morphine
    Primary Outcome Measure Information:
    Title
    pain intensity reports
    Title
    frequency and type of side effects
    Title
    blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide
    Secondary Outcome Measure Information:
    Title
    quantification of wound healing
    Title
    change in use of regular analgesics

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Moderate to severe resting pain (scores above 5/10). Stable analgesic regimen. No surgical interventions planned during the study period. Able to self-assess pain and report it. Hospitalized or receiving home care for Stage I; out-patients or receiving home care for Stage II. Wound not infected or covered with necrotic tissue. Exclusion Criteria: True sensitivity to opioids
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pesach Shvartzman, Professor
    Organizational Affiliation
    Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain

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