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Neuropathic Pain Caused by Radiation Therapy (NP)

Primary Purpose

Neuropathic Pain Secondary to Radiation Therapy

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel)
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain Secondary to Radiation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BC Cancer Agency Vancouver Island BCCA

Outcomes

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.

Secondary Outcome Measures

Skin Toxicity Assessment Tool (STAT)

Full Information

First Posted
November 21, 2008
Last Updated
June 21, 2011
Sponsor
British Columbia Cancer Agency
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1. Study Identification

Unique Protocol Identification Number
NCT00798083
Brief Title
Neuropathic Pain Caused by Radiation Therapy
Acronym
NP
Official Title
Topical Amitriptyline, Ketamine and Lidocaine in Neuropathic Pain Caused by Radiation Skin Reaction: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
British Columbia Cancer Agency

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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. Hypothesis:Topical AKL in PLO gel can effectively and safely reduce neuropathic pain experienced by patients with radiotherapy induced skin reactions. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain Secondary to Radiation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Uzaraga, MD
Organizational Affiliation
BC Cancer Agency - Vancouver Island Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Agency Vancouver Island BCCA
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada

12. IPD Sharing Statement

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Neuropathic Pain Caused by Radiation Therapy

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