CompletedPhase 3ketamine

Neuropathic Pain Caused by Radiation Therapy

Sponsored by British Columbia Cancer Agency

NCT ID
NCT00798083
Target Enrollment
22 participants
Start Date
2008-04
Est. Completion
2009-07

About This Study

To investigate if topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel (AKL in PLO gel) can improve management of neuropathic pain from radiation skin reactions adjunctively or better than standard treatment.

Conditions Studied

Neuropathic Pain Secondary to Radiation Therapy

Interventions

  • topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel)

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Age greater or equal to 18 years with ability to provide written informed consent.
* Subjects currently receiving radiation therapy or having completed radiotherapy in less than 4 weeks from study entry, who have developed skin reactions that are painful.
* Radiation skin reaction pain has qualities of burning as scored on UWNPS of 1 or more
* Skin toxicity Assessment Tool showing dry desquamation or worse
* Presence of objective dynamic allodynia and/or pinprick hyperalgesia as assessed by physician
* Subjects show less than 1 point decrease in UWNPS after 2 days of using standard intervention.
* Subjects are allergic or intolerant to standard intervention.
* Subjects must be available by telephone 2 and 6 weeks after RT treatment is completed.

Exclusion Criteria:

* Allergy to amitriptyline, ketamine or lidocaine
* Untreated severe major depression
* Ongoing use of monoamine oxidase inhibitor
* Pain from another source as severe or greater than the pain under study
* Evidence of another type of neuropathic pain not included in this study.
* Normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-report questionnaires
* Not pregnant or breastfeeding

Study Locations (1)

BC Cancer Agency Vancouver Island BCCA
Victoria, British Columbia, Canada

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source