N/A Completed N=50 Randomized Double-blind Supportive Care

Venlafaxine in Preventing Chronic Oxaliplatin-Induced Neuropathy In Patients Receiving Combination Chemotherapy

Source: ClinicalTrials.gov NCT01611155 ↗

Enrolled (actual)

Serious AEs

8.2%

Results posted

Sep 2019

Primary outcomePrimary: Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 — 96.22; 95.83 score on a scale — p=0.87

Summary

You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)

Outcome Measures

Outcome	Result	p-value
PRIMARY Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20	96.22; 95.83	0.87
SECONDARY Cycle 1 Acute Neuropathy as Measured by EORTC QLQ CIPN20 Motor Subscale (Items 37, 38, 41-45 and 49), and Autonomic Scale (Items 46, 47, 50)	97.28; 95.98; 91.36; 90.74	0.53

Eligibility Criteria

Inclusion Criteria

Scheduled to receive FOLFOX chemotherapy with individual oxaliplatin doses of 85 mg/m^2 per cycle given in 2 week cycles (e.g. modified [m] FOLFOX6 or FOLFOX4) Adequate complete blood count (CBC) and creatinine values (per attending physician) obtained = = 4 months Strong inhibitors of CYP3A4: > 5-fold increase in the plasma area under the curve (AUC) values or more than 80 % decrease in clearance
Indinavir (Crixivan®)
Nelfinavir (Viracept®)
Atazanavir (Reyataz®)
Ritonavir (Norvir®)
Clarithromycin (Biaxin®, Biaxin XL®)
Itraconazole (Sporanox®)
Ketoconazole (Nizoral®)
Nefazodone (Serzone®)
Saquinavir (Fortovase®, Invirase®)
Telithromycin (Ketek®) Inducers of CYP3A4
Efavirenz (Sustiva®)
Nevirapine (Viramune®)
Carbamazepine (Carbatrol®, Epitol®, Equetro™, Tegretol®, Tegretol-XR®)
Modafinil (Provigil®)
Phenobarbital (Luminal®)
Phenytoin (Dilantin®, Phenytek®)
Pioglitazone (Actos®)
Rifabutin (Mycobutin®)
Rifampin (Rifadin®)
St. John's wort

Exclusion Criteria

Any of the following:

Pregnant women
Nursing women History of an allergic reaction to, or intolerance of, venlafaxine Treatment = 2-fold increase in the plasma AUC values or 50-80% decrease in clearance
Aprepitant (Emend®)
Erythromycin (Erythrocin®, E.E.S. ®, Ery-Tab®, Eryc®, EryPed®, PCE®
Fluconazole (Diflucan®)
Grapefruit juice
Verapamil (Calan®, Calan SR®, Covera-HS®, Isoptin SR®, Verelan®, Verelan PM®)
Diltiazem (Cardizem®, Cardizem CD®, Cardizem LA®, Cardizem SR®, Cartia XT™, Dilacor XR®, Diltia XT®, Taztia XT™, Tiazac®) Other medical conditions which, in the opinion of the treating physician/allied health professional, would make this protocol unreasonably hazardous for the patient Prior neurotoxic chemotherapy Concurrent radiotherapy Current (within the last month) pre-existing peripheral neuropathy of any grade Uncontrolled hypertension (defined as 3 consecutive readings over the past year of over 160 systolic, and over 100 diastolic)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01611155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.