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NCT Number: NCT01869569

Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Center of Sun Yat-sen University, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Pregabalin

Drug

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

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Brief Pain Inventory (BPI)

    Time frame: week 16

    The investigators compare the BPI scores at week 16 with those at baseline.

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 5, 2013
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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