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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcer Wounds and Injuries

Keywords

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Skin ulcers Topical morphine Chronic pain Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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topical morphine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pesach Shvartzman

Head-Department of Family Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pesach Shvartzman, Professor

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care

Countries

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Israel

Other Identifiers

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SOR394105CTIL

Identifier Type: -

Identifier Source: org_study_id