Effect of Pregabalin in Patients With Radiotherapy-related Neuropathic Pain
Ključne besede
Povzetek
Opis
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.
Datumi
| Nazadnje preverjeno: | 04/30/2018 |
| Prvič predloženo: | 05/25/2013 |
| Predviden vpis oddan: | 06/03/2013 |
| Prvič objavljeno: | 06/04/2013 |
| Zadnja posodobitev oddana: | 05/22/2018 |
| Zadnja posodobitev objavljena: | 05/24/2018 |
| Dejanski datum začetka študija: | 01/31/2013 |
| Predvideni datum primarnega zaključka: | 09/30/2016 |
| Predvideni datum zaključka študije: | 12/31/2016 |
Stanje ali bolezen
Intervencija / zdravljenje
Drug: Pregabalin
Drug: Placebo
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| 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. |
| 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. |
Merila upravičenosti
| Starost, primerna za študij | 18 Years Za 18 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | 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 /= 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. |
Izid
Primarni izidni ukrepi
1. Numeric Rating Scale (NRS) at week 16 [week 16]
Ukrepi sekundarnega rezultata
1. Brief Pain Inventory (BPI) [week 16]
2. the Profile of Mood States-Short Form (POMS-SF) [week 16]
3. the World Health Organization Quality of Life-BREF (WHOQOL-BREF) [week 16]
4. Patient Global Impression of Change (PGIC) [week 16]
5. Clinical Global Impression of Change (CGIC) [week 16]
