Neuropathic Pain Caused by Radiation Therapy

Neuropathic Pain Secondary to Radiation Therapy Clinical Trial

— NP  

Official title:

Topical Amitriptyline, Ketamine and Lidocaine in Neuropathic Pain Caused by Radiation Skin Reaction: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798083
• Other study ID #: BCCA001
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2008
• Last updated: June 21, 2011
• Start date: April 2008
• Est. completion date: July 2009

Study information

• Verified date: June 2011
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain Secondary to Radiation Therapy

Intervention

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.

Locations

Country	Name	City	State
Canada	BC Cancer Agency Vancouver Island BCCA	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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.	Yes
Secondary	Skin Toxicity Assessment Tool (STAT)		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.	Yes