Oxycodone and Pregabalin for the Treatment of Oncological Neuropathic Pain

Associazione Progetto Oncologia UMAN.A80 enrolled

Overview

The aim of the study is to assess tolerability and activity of oxycodone and pregabalin in combination for the treatment of oncological neuropathic pain with two different strategies.

Neuropathic pain is frequently diagnosed as a complication of cancer pain. While opioids are the mainstay of cancer pain management,their efficacy in neuropathic pain seems to be less then optimal,and adjuvant drugs, mainly anticonvulsants and antidepressants,are often combined with opioids in the analgesic regimen of patients with neuropathic cancer pain. This approach is suggested by well-established guidelines, but the analgesic benefit and the safety of pregabalin and oxycodone in combination is not yet documented. The aim of this study is to assess the activity and tolerability of the addition of pregabalin to oxycodone in the treatment of patients with neuropathic pain due to neoplasm.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Pain

Interventions

oxycodoneDRUG

Arm A - 20 mg/day Arm B - increasing dose startnig at 20 mg/day For 15 days or until unacceptable toxicity develops.

pregabalinDRUG

Arm A - pregabalin at increasing dose starting from 50 mg/day Arm B - pregabalin 50 mg/day For 15 days or until unacceptable toxicity develops.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * instrumental and clinical diagnosis of every malignant neoplasm * presence of pain with a neuropathic component in the opinion of the physician * presence of pain \>=4(NRS) * PS ECOG \<3 * written informed consent Exclusion Criteria: * serum creatinine \>2mg/ml or creatinine clearance \<40 ml/min * mild or severe hepatic insufficiency * iatrogenic neuropathy caused by chemotherapeutic agents * previous allergic reactions to oxycodone and pregabalin * pregnancy or breastfeeding

Locations (8)

Ospedale Fatebenefratelli

Benevento, Benevento, Italy

Ospedali Riuniti

Bergamo, Bergamo, Italy

Ospedale S. Orsola

Brescia, Brescia, Italy

Ospedale Serbelloni

Gorgonzola, Milano, Italy

Outcomes

Primary Outcomes

Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale

Time frame: within 15 days

Secondary Outcomes

Pain control rate

Time frame: within 15 days

Reduction of Break Through Pain number

Time frame: within 15 days

Record of adverse events

Time frame: within 15 days

Reduction of allodynia in patients presenting it at T0

Time frame: within 15 days

Patient satisfaction

Time frame: within 15 days

Assessing whether COMT and mu blood polymorphisms are associated to response

Time frame: within 15 days

Data from ClinicalTrials.gov

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