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

NCT01611155 | Completed Results DMC

• 2 other identifiers: MC11C4NCI-2012-00318
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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

  The EORTC QLQ-CIPN20 sensory neuropathy score will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation.

  Up to 2 weeks

Secondary Outcomes (1)

• 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)

  Up to 2 weeks

Study Arms (2)

Arm I (management of therapy complications)

EXPERIMENTAL

Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.

Drug: venlafaxine; Other: questionnaire administration; Other: quality-of-life assessment

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.

Drug: placebo; Other: questionnaire administration; Other: quality-of-life assessment

Interventions

venlafaxine DRUG

Given PO

Also known as: Effexor, VNF

Arm I (management of therapy complications)

placebo DRUG

Given PO

Also known as: PLCB

Arm II (placebo)

questionnaire administration OTHER

Ancillary studies

Arm I (management of therapy complications); Arm II (placebo)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (management of therapy complications); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 =\< 28 days prior to registration Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2 Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential Ability to complete questionnaire(s) by themselves or with assistance Life expectancy \>= 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®)

You may not qualify if:

• Any of the following:
• Pregnant women
• Nursing women History of an allergic reaction to, or intolerance of, venlafaxine Treatment =\< 7 days with other antidepressants, anticonvulsants, monoamine oxidase (MAO) inhibitors, or other neuropathic pain medication agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch or gel, capsaicin cream, or amifostine; in addition, they may not be taking other agents for the treatment of neuropathy, nor other known moderate or strong CYP 2D6 (which consist of Cinacalcet \[Sensipar™\], quinidine, and Terbinafine \[Lamisil®, Lamisil AT®\]), nor the strong inducer of CYP 2D6 terbinafine (Lamisil®, Lamisil AT®), nor the following drugs that substantially effect CYP 3A4 Moderate inhibitors of CYP3A4: \> 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Zimmerman C, Atherton PJ, Pachman D, Seisler D, Wagner-Johnston N, Dakhil S, Lafky JM, Qin R, Grothey A, Loprinzi CL. MC11C4: a pilot randomized, placebo-controlled, double-blind study of venlafaxine to prevent oxaliplatin-induced neuropathy. Support Care Cancer. 2016 Mar;24(3):1071-8. doi: 10.1007/s00520-015-2876-5. Epub 2015 Aug 8.

  PMID: 26248652 DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Results Point of Contact

• Title: Charles L. Loprinzi, MD
• Organization: Mayo Clinic

cloprinzi@mayo.edu

507-284-3731

Study Officials

• Charles Loprinzi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: February 17, 2012
• Primary Completion: March 7, 2014
• Study Completion: September 23, 2015
• Last Updated: September 26, 2019
• Results First Posted: September 26, 2019

Record last verified: 2018-10

Locations

US (1)