NCT00798083

Neuropathic Pain Caused by Radiation Therapy

Topical Amitriptyline, Ketamine and Lidocaine in Neuropathic Pain Caused by Radiation Skin Reaction: a Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathic Pain Secondary to Radiation Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-11-25
• Last updated: 2011-06-22

Locations

1 site across 1 country: Canada