Neuropathic Pain Caused by Radiation Therapy | RxWiki

Neuropathic Pain Caused by Radiation Therapy

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Neuropathic Pain Secondary to Radiation Therapy
Intervention	Drug: topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel)
Phase	Phase 3
Sponsor	British Columbia Cancer Agency
Responsible Party	British Columbia Cancer Agency
ClinicalTrials.gov Identifier	NCT00798083
First Received	November 21, 2008
Last Updated	June 21, 2011
Last verified	June 2011

Tracking Information[ + expand ][ + ]

First Received Date	November 21, 2008
Last Updated Date	June 21, 2011
Start Date	April 2008
Estimated Primary Completion Date	July 2009
Current Primary Outcome Measures	The primary outcome measure will to use the validated University of Washington Neuropathic Pain Scale (UWNPS) on all radiation skin reaction subjects requiring standard intervention. [Time Frame: University of Washington Neuropathic Pain scale will be conducted at the time of assessment, every 2-5 days while on radiotherapy, week 2 and 6 weeks post radiotherapy.] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Skin Toxicity Assessment Tool (STAT) [Time Frame: Presence of dry desquamation or worse on STAT at baseline assessment, complete STAT 30 minutes post application of cream, every 2-5 days while on radiotherapy, week 2 and 6 weeks after completing radiation therapy.] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Neuropathic Pain Caused by Radiation Therapy
Official Title	Topical Amitriptyline, Ketamine and Lidocaine in Neuropathic Pain Caused by Radiation Skin Reaction: a Pilot Study
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 adjunctively or better than standard treatment.
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 of all three topical drugs combined in radiation skin reactions. There currently is no research evidence for the use of all three compounded interventions. This study aims to target subjects with pain from radiation therapy who are not receiving adequate relief with standard interventions and may be eligible to receive this alternate intervention. 2. Hypothesis:Topical AKL in PLO gel can effectively and safely reduce neuropathic pain experienced by patients with radiotherapy induced skin reactions. 3. Justification: Standard treatment of painful radiation skin reactions such as moist desquamation consists of saline soaks, silver sulfadiazine and oral analgesics. However, sometimes the pain exceeds this standard intervention, patients are sulfa allergic or patients are intolerant to oral analgesics such as opioids. AKL in PLO gel is targeted for neuropathic pain and may be used alternatively to standard interventions. The participation rate will help to further estimate the feasibility of a larger sample size study to look at efficacy.
Study Type	Interventional
Study Phase	Phase 3
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Neuropathic Pain Secondary to Radiation Therapy
Intervention	Drug: topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel) Subjects will be taught to apply topical 2%amitriptyline, 1% ketamine and 5% lidocaine(AKL) in PLO gel to the sites of maximum neuropathic pain three times per day for up to 2 weeks after completion of radiotherapy.
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	22
Estimated Completion Date	July 2009
Estimated Primary Completion Date	July 2009
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Canada

Administrative Information[ + expand ][ + ]

NCT Number	NCT00798083
Other Study ID Numbers	BCCA001
Has Data Monitoring Committee	Yes
Information Provided By	British Columbia Cancer Agency
Study Sponsor	British Columbia Cancer Agency
Collaborators	Not Provided
Investigators	Principal Investigator: Isabella Uzaraga, MD BC Cancer Agency - Vancouver Island Centre
Verification Date	June 2011

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