Topical Amitriptyline, Ketamine and Lidocaine in Neuropathic Pain Caused by Radiation Skin Reaction: a Pilot Study
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
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.
Isabella Uzaraga, MD
BC Cancer Agency - Vancouver Island Centre
Canada: Ethics Review Committee