Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

May 23, 2018 updated by: Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Effect of Pregabalin in Patients With Radiotherapy-Related Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, aching, spasm, or tingling. Though there is some recommendation about neuropathic pain, there is no definite drug which is recommended for radiotherapy-related neuropathic pain.

Pregabalin, a central nervous system(CNS)-active compound, is an analog of the neurotransmitter gamma-aminobutyric acid. It has been proved an effective treatment for diabetic peripheral neuropathy and postherpetic neuralgia in previous clinical trials. This study plans to evaluate the efficacy of pregabalin versus placebo for relieving radiotherapy-related peripheral neuropathic pain, and assessed its safety.

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510450
        • Guangzhou Huiai Hospital
      • Guangzhou, Guangdong, China, 510060
        • Cancer center of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 511300
        • Zengcheng People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 </=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.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pregabalin
Arm I:At the 4-week dose-titration phase, will receive one capsule of pregabalin (75 mg) twice daily from Day 1 to Day 7, and two capsules of pregabalin (150 mg) twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of pregabalin.
Drug: Pregabalin
At the 4-week dose-titration phase, will receive one capsule of pregabalin (75 mg) twice daily from Day 1 to Day 7, and two capsules of pregabalin (150 mg) twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of pregabalin.
Other Names:
  • Lyrica
PLACEBO_COMPARATOR: Placebo
Arm II:At the 4-week dose-titration phase, will receive one capsule of placebo twice daily from Day 1 to Day 7, and two capsules of placebo twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of placebo.
Drug: Placebo
At the 4-week dose-titration phase, will receive one capsule of placebo twice daily from Day 1 to Day 7, and two capsules of placebo twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) at week 16
Time Frame: week 16
The primary efficacy measure is the reduction of NRS from baseline to week 16.
week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI)
Time Frame: week 16
The investigators compare the BPI scores at week 16 with those at baseline.
week 16
the Profile of Mood States-Short Form (POMS-SF)
Time Frame: week 16
The investigators compare the POMS-SF scores at week 16 with those at baseline.
week 16
the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time Frame: week 16
The investigators compare the WHOQOL-BREF scores at week 16 with those at baseline.
week 16
Patient Global Impression of Change (PGIC)
Time Frame: week 16
Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC). A treatment success is defined as Much or Very Much Improved at the Week 16. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved
week 16
Clinical Global Impression of Change (CGIC)
Time Frame: week 16
Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC) . A treatment success is defined as Much or Very Much Improved at the Week 16. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improve.
week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Yamei Tang, M.D.,PhD., Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2013

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

May 26, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (ESTIMATE)

June 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012026
  • SYSN002 (OTHER: Sun Yat-sen Memorial Hospital, Neurology department)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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