Overview

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