Status:
COMPLETED
Neuropathic Pain Caused by Radiation Therapy
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Neuropathic Pain Secondary to Radiation Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 adjun...
Detailed Description
1. Topical amitriptyline and ketamine and topical lidocaine alone have been shown to improve management of neuropathic pain in nonmalignant subjects. Anecdotal experience has shown improvement in use ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00798083
Start Date
April 1 2008
End Date
July 1 2009
Last Update
June 22 2011
Active Locations (1)
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1
BC Cancer Agency Vancouver Island BCCA
Victoria, British Columbia, Canada, V8R 6V5