Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869569
• Other study ID #: 2012026
• Secondary ID: SYSN002
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: January 2017

Study information

• Verified date: May 2018
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Cancer Center of Sun Yat-sen University	Guangzhou	Guangdong
China	Guangzhou Huiai Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Zengcheng People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS) at week 16	The primary efficacy measure is the reduction of NRS from baseline to week 16.	week 16
Secondary	Brief Pain Inventory (BPI)	The investigators compare the BPI scores at week 16 with those at baseline.	week 16
Secondary	the Profile of Mood States-Short Form (POMS-SF)	The investigators compare the POMS-SF scores at week 16 with those at baseline.	week 16
Secondary	the World Health Organization Quality of Life-BREF (WHOQOL-BREF)	The investigators compare the WHOQOL-BREF scores at week 16 with those at baseline.	week 16
Secondary	Patient Global Impression of Change (PGIC)	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
Secondary	Clinical Global Impression of Change (CGIC)	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