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CompletedNCT00798083NPUpdated Jun 22, 2011

Neuropathic Pain Caused by Radiation Therapy

A Phase 3 interventional study of topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel) in Neuropathic Pain Secondary to Radiation Therapy, sponsored by British Columbia Cancer Agency. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-22.

Sponsored by British Columbia Cancer Agency · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
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Conditions studied

  • Neuropathic Pain Secondary to Radiation Therapy

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03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's planned enrollment of 22 is below the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Interventions

  • Drugtopical 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.

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What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

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Study locations

1 site
  • BC Cancer Agency Vancouver Island BCCA
    Victoria, British Columbia V8R 6V5, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00798083
Lead sponsor
British Columbia Cancer Agency
First posted
Nov 25, 2008
Start date
Apr 2008
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Jun 22, 2011

Study contacts

Isabella Uzaraga, MD
principal investigator · BC Cancer Agency - Vancouver Island Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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