Neuropathic Pain Caused by Radiation Therapy - Full Text View

Sponsored by:	British Columbia Cancer Agency
Information provided by:	British Columbia Cancer Agency
ClinicalTrials.gov Identifier:	NCT00798083

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 III

Drug Information available for: Amitriptyline Amitriptyline hydrochloride Lidocaine Ketamine Ketamine hydrochloride Poloxamer

U.S. FDA Resources

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

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
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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:

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.

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

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

Contacts

Contact: Isabella Uzaraga

250 519 5500

iuzaraga@bccancer.bc.ca

Locations

Canada, British Columbia
BC Cancer Agency Vancouver Island BCCA	Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Isabella Uzaraga 250 519 5500 iuzaraga2@bccancer.bc.ca

Sponsors and Collaborators

British Columbia Cancer Agency

Investigators

Principal Investigator:

Isabella Uzaraga, MD

BC Cancer Agency - Vancouver Island Centre

More Information

Responsible Party:	British Columbia Cancer Agency - Vancouver Island Centre ( Isabella Uzaraga )
Study ID Numbers:	BCCA001
Study First Received:	November 21, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00798083
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Excitatory Amino Acids
Amitriptyline
Ketamine

Lidocaine
Neoplasm Metastasis
Pain

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Excitatory Amino Acid Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Anti-Arrhythmia Agents

Antidepressive Agents
Excitatory Amino Acid Antagonists
Anesthetics, Intravenous
Central Nervous System Depressants
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Dissociative
Anesthetics, Local
Antidepressive Agents, Tricyclic
Analgesics, Non-Narcotic
Anesthetics, General
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 06, 2009