NCT00306020

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

6.4 years

First QC Date

March 21, 2006

Last Update Submit

July 3, 2012

Conditions

UlcerWounds and Injuries

Keywords

Skin ulcersTopical morphineChronic painCancer

Outcome Measures

Primary Outcomes (3)

  • pain intensity reports

  • frequency and type of side effects

  • blood and urine levels of morphine and its metabolites, morphine 3- and 6-glucuronide

Secondary Outcomes (2)

  • quantification of wound healing

  • change in use of regular analgesics

Interventions

topical morphineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • True sensitivity to opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

UlcerWounds and InjuriesSkin UlcerChronic PainNeoplasms

Interventions

Morphine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Pesach Shvartzman, Professor

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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head-Department of Family Medicine

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 22, 2006

Study Start

January 1, 2006

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 4, 2012

Record last verified: 2012-07