Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

NCT01869569 | Completed Phase 2 DMC

• 2 other identifiers: 2012026SYSN002
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 4

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 treating radiotherapy-related neuropathic pain.

Conditions

Neuropathic Pain

Keywords

Radiation; Neuropathic Pain; Pregabalin

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) at week 16

  The primary efficacy measure is the reduction of NRS from baseline to week 16.

  week 16

Secondary Outcomes (5)

• Brief Pain Inventory (BPI)

  week 16

• the Profile of Mood States-Short Form (POMS-SF)

  week 16

• the World Health Organization Quality of Life-BREF (WHOQOL-BREF)

  week 16

• Patient Global Impression of Change (PGIC)

  week 16

• Clinical Global Impression of Change (CGIC)

  week 16

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Lyrica

Pregabalin

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (4)

Cancer Center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Guangzhou Huiai Hospital

Guangzhou, Guangdong, 510450, China

Location

Zengcheng People's Hospital

Guangzhou, Guangdong, 511300, China

Location

Related Publications (1)

• Jiang J, Li Y, Shen Q, Rong X, Huang X, Li H, Zhou L, Mai HQ, Zheng D, Chen MY, Xu Y, Li J, Hui X, Simone CB 2nd, Gaertner J, Argyriou AA, Chow E, Chen P, Tang Y. Effect of Pregabalin on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancer: A Randomized Controlled Trial. J Clin Oncol. 2019 Jan 10;37(2):135-143. doi: 10.1200/JCO.18.00896. Epub 2018 Nov 20.

  PMID: 30457920 DERIVED

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yamei Tang, M.D.,PhD.

  Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2013
• First Posted: June 5, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: May 25, 2018

Record last verified: 2018-05

Locations

CN (4)