Evaluate The Efficacy and Safety Of Pregabalin In Prevention, Reduction of Oxaliplatin-Induced Painful Neuropathy
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Oxaliplatin (Ox) is part of most treatment regimens for colorectal cancer. However, it may
induce side effects, such as a specific injury to peripheral nerves called neuropathy.
Ox-induced neuropathy is frequently painful. The presence of pain after its administration
may hamper the full chemotherapeutic treatment of patients with colorectal cancer receiving
this agent. Recently, it has been suggested that the appearance of acute neuropathy after
oxaliplatin (Ox) infusion could predict the distal polyneuropathy seen some months after
treatment. These two adverse events related to Ox treatment probably share different
mechanistic backgrounds. However, recent experimental data suggest that both types of
peripheral neuropathies are able to induce central sensitization, a major step to the
occurrence of chronic pain. Pregabalin is a molecule used to teat neuropathic pain since it
can diminish the peripheral sensitization seen in this painful condition. Recently, it has
also been shown that pregabalin can be used to treat neuropathic pain related to Ox
treatment. In the present study, we will test the hypothesis that Pregabalin administrated
exclusively for three days before and three days after the Ox infusion is able to prevent the
occurrence of pain secondary to both the acute and chronic Ox-associated neuropathies. In the
classical FLOX chemotherapeutic regimen, Ox is infused in nine sessions during a six-month
period. Patients will be followed for a year and nerve conduction tests, quantitative sensory
evaluation, pain, quality of life and functional scales will be used to assess the impact of
this strategy in the prevention of pain. If this strategy proves to work, this information
will have a major impact in the cancer prognosis of patients with colorectal cancer since Ox
will be able to administer in its full dose, and will not be limited by neuropathic side
effects.