Venlafaxine for prevention of oxaliplatin-induced peripheral neuropathy - A randomised clinical trial

Venlafaxine for prevention of oxaliplatin-induced peripheral neuropathy - A randomised clinical trial - VENLOX

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42624

Enrollment

150

Registered

2017-02-01

Start date

2016-02-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nerve damage neuropathy

Interventions

Patients will be randomly assigned to receive one of the following double-blind treatments during the course of chemotherapy: Venlafaxine hydrochloride extended release capsules (XR) or matching pla

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence of oxaliplatin-induced peripheral neuropathy grade >=1 during treatment, measured by the NCI-CTCAE scale. It will be measured after 3 cycles of 3-weekly (130mg/m2) treatments. At this point in treatment total dose is 390 mg/m2. Retrospective research showed that at this time point the chronic neuropathy usually manifests.	—

Secondary

Measure	Time frame
1. To study the effect of venlafaxine on the incidence of acute OIPN (NCI-CTCAE scoring) in patients treated with oxaliplatin containing chemotherapy 2. To study the effect of venlafaxine on the maximal severity of OIPN (NCI-CTCAE scoring) in patients treated with oxaliplatin containing chemotherapy 3. To study the effect of venlafaxine on the onset of chronic OIPN as defined by cumulative dose of oxaliplatin when first symptoms occur 4. To study the effect of venlafaxine on the Quality of Life (QOL) during chemotherapy and after 3, 6 and 12 months of oxaliplatin use as scored by the EORTC QLQ-CIPN20 questionnaire. 5. To determine safety of venlafaxine in patients treated with oxaliplatin containing chemotherapy.	—

Measure

Time frame

1. To study the effect of venlafaxine on the incidence of acute OIPN (NCI-CTCAE scoring) in patients treated with oxaliplatin containing chemotherapy 2. To study the effect of venlafaxine on the maximal severity of OIPN (NCI-CTCAE scoring) in patients treated with oxaliplatin containing chemotherapy 3. To study the effect of venlafaxine on the onset of chronic OIPN as defined by cumulative dose of oxaliplatin when first symptoms occur 4. To study the effect of venlafaxine on the Quality of Life (QOL) during chemotherapy and after 3, 6 and 12 months of oxaliplatin use as scored by the EORTC QLQ-CIPN20 questionnaire. 5. To determine safety of venlafaxine in patients treated with oxaliplatin containing chemotherapy.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)