Neuropathic Pain Caused by Radiation Therapy

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Ketamine; Lidocaine

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