Status:
COMPLETED
Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Radiotherapy for cancer is associated with peripheral neuropathies, especially with brachial plexus neuropathy and trigeminal neuralgia, which included painful sensation that are described as burning,...
Eligibility Criteria
Inclusion
- Patients must have received radiation therapy for histologically confirmed head and neck cancer.
- 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).
- 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.
- The mean duration of pain is more than 4 weeks.
- Fertile women who are willing to take contraception during the trial.
- Routine laboratory studies with bilirubin \</=2 \* upper limits of normal (ULN), 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.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion
- Current diagnosis of tumor recurrence or metastasis and evidence of tumor associated pain.
- Evidence of secondary neuropathic pain other than radiation.
- Treatment with carbamazepine, gabapentin or pregabalin within 30 days before study enrollment.
- Ongoing treatment for neuropathic pain.
- History of anaphylactic response to pregabalin.
- Evidence of sever systematic diseases.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01869569
Start Date
February 1 2013
End Date
January 1 2017
Last Update
May 25 2018
Active Locations (4)
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1
Cancer Center of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
2
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
3
Guangzhou Huiai Hospital
Guangzhou, Guangdong, China, 510450
4
Zengcheng People's Hospital
Guangzhou, Guangdong, China, 511300