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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00306020
• Other study ID #: SOR394105CTIL
• Status: Withdrawn
• Phase: N/A
• First received: March 21, 2006
• Last updated: July 3, 2012
• Start date: January 2006
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ulcer
• Wounds and Injuries

Intervention

Drug:
• topical morphine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Soroka University Medical Center	Israel Cancer Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity reports
Primary	frequency and type of side effects
Primary	blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide
Secondary	quantification of wound healing
Secondary	change in use of regular analgesics