Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuropathic Pain Caused by Radiation Therapy (NP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00798083
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:
British Columbia Cancer Agency

Tracking Information
First Submitted Date  ICMJE November 21, 2008
First Posted Date  ICMJE November 25, 2008
Last Update Posted Date June 22, 2011
Study Start Date  ICMJE April 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuropathic Pain Caused by Radiation Therapy
Official Title  ICMJE Topical Amitriptyline, Ketamine and Lidocaine in Neuropathic Pain Caused by Radiation Skin Reaction: a Pilot Study
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
  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain Secondary to Radiation Therapy
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 24, 2008)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798083
Other Study ID Numbers  ICMJE BCCA001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabella Uzaraga, British Columbia Cancer Agency - Vancouver Island Centre
Study Sponsor  ICMJE British Columbia Cancer Agency
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isabella Uzaraga, MD BC Cancer Agency - Vancouver Island Centre
PRS Account British Columbia Cancer Agency
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP