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
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