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

This study has been withdrawn prior to enrollment.
(The study was withdrawn due to difficulties in recruiting appropriate patients in community clinic setting)
Sponsor:
Collaborator:
Israel Cancer Association
Information provided by (Responsible Party):
Pesach Shvartzman, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00306020
First received: March 21, 2006
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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 Intervention
Ulcer
Wounds and Injuries
Drug: topical morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Analgesia and Wound Healing Assessment Following Topical Morphine Applied to Patients With Cutaneous Cancer Related Pain

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

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

Enrollment: 0
Study Start Date: January 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306020

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

No publications provided

Responsible Party: Pesach Shvartzman, Head-Department of Family Medicine, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00306020     History of Changes
Other Study ID Numbers: SOR394105CTIL
Study First Received: March 21, 2006
Last Updated: July 3, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Skin ulcers
Topical morphine
Chronic pain
Cancer

Additional relevant MeSH terms:
Ulcer
Wounds and Injuries
Pathologic Processes
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 22, 2014