Clinical trial NCT00306020: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Ulcer
Wounds and Injuries
Keywords: Skin ulcers
Topical morphine
Chronic pain
Cancer
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Israel Cancer Association
First posted: 2006-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: pain intensity reports
measure: frequency and type of side effects
measure: blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide
Secondary outcomes:
measure: quantification of wound healing
measure: change in use of regular analgesics
Other outcomes:
Locations:
Study officials:
affiliation: Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care
name: Pesach Shvartzman, Professor
role: PRINCIPAL_INVESTIGATOR
References: