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Withdrawn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
About this trial
This is an interventional treatment trial for Ulcer focused on measuring Skin ulcers, Topical morphine, Chronic pain, Cancer
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
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
NCT ID
NCT00306020
First Posted
March 21, 2006
Last Updated
July 3, 2012
Sponsor
Soroka University Medical Center
Collaborators
Israel Cancer Association
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Withdrawn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The study was withdrawn due to difficulties in recruiting appropriate patients in community clinic setting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
We'll reach out to this number within 24 hrs