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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306020
Recruitment Status : Withdrawn (The study was withdrawn due to difficulties in recruiting appropriate patients in community clinic setting)
First Posted : March 22, 2006
Last Update Posted : July 4, 2012
Israel Cancer Association
Information provided by (Responsible Party):
Pesach Shvartzman, Soroka University Medical Center

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.

Condition or disease Intervention/treatment Phase
Ulcer Wounds and Injuries Drug: topical morphine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain
Study Start Date : January 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. pain intensity reports
  2. frequency and type of side effects
  3. blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide

Secondary Outcome Measures :
  1. quantification of wound healing
  2. change in use of regular analgesics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306020

Sponsors and Collaborators
Soroka University Medical Center
Israel Cancer Association
Principal Investigator: Pesach Shvartzman, Professor Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care

Responsible Party: Pesach Shvartzman, Head-Department of Family Medicine, Soroka University Medical Center Identifier: NCT00306020     History of Changes
Other Study ID Numbers: SOR394105CTIL
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012

Keywords provided by Pesach Shvartzman, Soroka University Medical Center:
Skin ulcers
Topical morphine
Chronic pain

Additional relevant MeSH terms:
Wounds and Injuries
Cancer Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents