Neuropathic Pain Caused by Radiation Therapy (NP)

This study has been completed.
Sponsor:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00798083
First received: November 21, 2008
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain Secondary to Radiation Therapy
Drug: topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topical Amitriptyline, Ketamine and Lidocaine in Neuropathic Pain Caused by Radiation Skin Reaction: a Pilot Study

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

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. [ 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: April 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798083

Locations
Canada, British Columbia
BC Cancer Agency Vancouver Island BCCA
Victoria, British Columbia, Canada, V8R 6V5
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Isabella Uzaraga, MD BC Cancer Agency - Vancouver Island Centre
  More Information

No publications provided

Responsible Party: Isabella Uzaraga, British Columbia Cancer Agency - Vancouver Island Centre
ClinicalTrials.gov Identifier: NCT00798083     History of Changes
Other Study ID Numbers: BCCA001
Study First Received: November 21, 2008
Last Updated: June 21, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lidocaine
Ketamine
Amitriptyline
Amitriptyline, perphenazine drug combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 22, 2014