Cancer, Pain
Conditions
Keywords
neuropathic pain, oxycodone, pregabalin, Patients with cancer and presenting a neuropathic pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGoxycodone
Arm A - 20 mg/day Arm B - increasing dose startnig at 20 mg/day For 15 days or until unacceptable toxicity develops.
DRUGpregabalin
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.
Sponsors
Mario Negri Institute for Pharmacological Research
Associazione Progetto Oncologia UMAN.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of analgesia (decrease of at least 1/3 of pain intensity) assessed by NRS scale | within 15 days |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of Break Through Pain number | within 15 days |
| Record of adverse events | within 15 days |
| Pain control rate | within 15 days |
| Patient satisfaction | within 15 days |
| Assessing whether COMT and mu blood polymorphisms are associated to response | within 15 days |
| Reduction of allodynia in patients presenting it at T0 | within 15 days |
Countries
Italy
Outcome results
None listed