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

Phase 3
18 Years
Not Enrolling
Neuropathic Pain Secondary to Radiation Therapy

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Trial Information

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.

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

- 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

- Subjects show less than 1 point decrease in UWNPS after 2 days of using standard

- Subjects are allergic or intolerant to standard intervention.

- Subjects must be available by telephone 2 and 6 weeks after RT treatment is

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome 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.

Safety Issue:


Principal Investigator

Isabella Uzaraga, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BC Cancer Agency - Vancouver Island Centre


Canada: Ethics Review Committee

Study ID:




Start Date:

April 2008

Completion Date:

July 2009

Related Keywords:

  • Neuropathic Pain Secondary to Radiation Therapy
  • Neuralgia