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Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Radiation, Neuropathic Pain, Pregabalin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Center of Sun Yat-sen University
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Guangzhou Huiai Hospital
  • Zengcheng People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pregabalin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric Rating Scale (NRS) at week 16
The primary efficacy measure is the reduction of NRS from baseline to week 16.

Secondary Outcome Measures

Brief Pain Inventory (BPI)
The investigators compare the BPI scores at week 16 with those at baseline.
the Profile of Mood States-Short Form (POMS-SF)
The investigators compare the POMS-SF scores at week 16 with those at baseline.
the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
The investigators compare the WHOQOL-BREF scores at week 16 with those at baseline.
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
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.

Full Information

First Posted
May 26, 2013
Last Updated
May 23, 2018
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01869569
Brief Title
Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain
Official Title
Effect of Pregabalin in Patients With Radiotherapy-Related Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Radiation, Neuropathic Pain, Pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Numeric Rating Scale (NRS) at week 16
Description
The primary efficacy measure is the reduction of NRS from baseline to week 16.
Time Frame
week 16
Secondary Outcome Measure Information:
Title
Brief Pain Inventory (BPI)
Description
The investigators compare the BPI scores at week 16 with those at baseline.
Time Frame
week 16
Title
the Profile of Mood States-Short Form (POMS-SF)
Description
The investigators compare the POMS-SF scores at week 16 with those at baseline.
Time Frame
week 16
Title
the World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Description
The investigators compare the WHOQOL-BREF scores at week 16 with those at baseline.
Time Frame
week 16
Title
Patient Global Impression of Change (PGIC)
Description
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
Time Frame
week 16
Title
Clinical Global Impression of Change (CGIC)
Description
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.
Time Frame
week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yamei Tang, M.D.,PhD.
Organizational Affiliation
Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Guangzhou Huiai Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510450
Country
China
Facility Name
Zengcheng People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511300
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30457920
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain

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