Venlafaxine for prevention of oxaliplatin-induced peripheral neuropathy - A randomised clinical trial
- Conditions
- nerve damageneuropathy1002765610034606
- Registration Number
- NL-OMON42624
- Lead Sponsor
- Maasstad Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
• 24 years or older
• Oxaliplatin based chemotherapy, XELOX regimen (with or without bevacizumab)
• Performance state of at least 2 (ECOG) or 60 (Karnofsky)
• Written informed consent
• Participating in other clinical trial (eg CAIRO 4 or Orchestra studies in
colorectal carcinoma patients)
• Brain or leptomeningeal metastasis
• Previous treatment with platinum based chemotherapy
• Alcohol addiction
• (Pre)existing neuropathy
• Use of anti-epileptics, anti-depressants, anti-retroviral drugs, MAO-inhibitors or lithium.
• Use of strong enzyme modulating drugs (CYP2D6): fluoxetine, bupropion, kinidine, paroxetine or ritonavir
• Psychologically instable, psychiatric disorder
• Known allergy for venlafaxine
• Pregnancy or breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the incidence of oxaliplatin-induced peripheral<br /><br>neuropathy grade >=1 during treatment, measured by the NCI-CTCAE scale. It will<br /><br>be measured after 3 cycles of 3-weekly (130mg/m2) treatments. At this point in<br /><br>treatment total dose is 390 mg/m2. Retrospective research showed that at this<br /><br>time point the chronic neuropathy usually manifests. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To study the effect of venlafaxine on the incidence of acute OIPN (NCI-CTCAE<br /><br>scoring) in patients treated with oxaliplatin containing chemotherapy<br /><br>2. To study the effect of venlafaxine on the maximal severity of OIPN<br /><br>(NCI-CTCAE scoring) in patients treated with oxaliplatin containing<br /><br>chemotherapy<br /><br>3. To study the effect of venlafaxine on the onset of chronic OIPN as defined<br /><br>by cumulative dose of oxaliplatin when first symptoms occur<br /><br>4. To study the effect of venlafaxine on the Quality of Life (QOL) during<br /><br>chemotherapy and after 3, 6 and 12 months of oxaliplatin use as scored by the<br /><br>EORTC QLQ-CIPN20 questionnaire.<br /><br>5. To determine safety of venlafaxine in patients treated with oxaliplatin<br /><br>containing chemotherapy.</p><br>