Neuropathic Pain Caused by Radiation Therapy (NP)

British Columbia Cancer Agency

Status and phase

Completed

Phase 3

Conditions

Neuropathic Pain Secondary to Radiation Therapy

Treatments

Drug: topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel(AKL in PLO gel)

Study type

Interventional

Funder types

Other

Identifiers

NCT00798083

BCCA001

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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