Overview

Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
Summary
Rationale: Pregabalin is effective on radiotherapy-related neuropathic pain. Purpose: This randomized, double-blind, placebo-controlled trial aims to investigate the effect and safety of pregabalin in treating radiotherapy-related neuropathic pain.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator:
National Natural Science Foundation of China
Treatments:
Pregabalin
Criteria
Inclusion Criteria:

1. Patients must have received radiation therapy for histologically confirmed head and
neck cancer.

2. Clinical evidence support the diagnosis of radiation-related neuropathic pain
(confirmed by the Michigan Neuropathy Screening Instrument) and had a daily pain score
of 4 or higher based on a numerical rating scale (0-10 points).

3. Neuropathic pain defined according to clinical history, symptoms, physical signs, and
a score>= 12 in Chinese version of Leeds Assessment of Neuropathic Symptoms and Signs
questionnaire by two neurology specialists.

4. The mean duration of pain is more than 4 weeks.

5. Fertile women who are willing to take contraception during the trial.

6. Routine laboratory studies with bilirubin aspartate aminotransferase (AST or SGOT) < 2 * ULN, creatinine <1.0 * ULN, red-cell
count >/= 4,000 per cubic millimeter; white-cell count >/=1500 per cubic millimeter,
platelets >/= 75,000 per cubic millimeter; Hb >/=9.0.

7. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Current diagnosis of tumor recurrence or metastasis and evidence of tumor associated
pain.

2. Evidence of secondary neuropathic pain other than radiation.

3. Treatment with carbamazepine, gabapentin or pregabalin within 30 days before study
enrollment.

4. Ongoing treatment for neuropathic pain.

5. History of anaphylactic response to pregabalin.

6. Evidence of sever systematic diseases.