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Trial record 9 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

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

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ClinicalTrials.gov Identifier: NCT01611155
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

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)

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Drug: venlafaxine Drug: placebo Other: questionnaire administration Other: quality-of-life assessment Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To explore whether venlafaxine can prevent or ameliorate chronic, cumulative neurotoxicity associated with oxaliplatin in cancer patients receiving oxaliplatin, fluorouracil, leucovorin calcium (FOLFOX).

SECONDARY OBJECTIVES:

I. To explore whether venlafaxine can ameliorate acute neuropathy associated with oxaliplatin.

TERTIARY OBJECTIVES:

I. To explore whether venlafaxine can increase the cumulative oxaliplatin doses that can be delivered without dose-limiting chronic neurotoxicity.

II. To explore whether venlafaxine causes adverse events in this setting. III. To explore whether the neuropathy data provided by the Rydel-Seiffer graduated tuning fork is consistent with patient-reported outcome (PRO) measures of chemotherapy-induced peripheral neuropathy (CIPN) and whether this tool might cause different results in patients receiving venlafaxine versus placebo.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive venlafaxine orally (PO) twice daily (BID) beginning on day 1 of and continuing through completion of FOLFOX.

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

After completion of study treatment, patients are followed up at 1, 3, 6, 12, and 18 months.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Randomized, Placebo-controlled, Double Blind Study of Venlafaxine to Prevent Oxaliplatin-Induced Neuropathy
Actual Study Start Date : February 17, 2012
Actual Primary Completion Date : March 7, 2014
Actual Study Completion Date : September 23, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (management of therapy complications)
Patients receive venlafaxine PO BID beginning on day 1 of and continuing through completion of FOLFOX.
Drug: venlafaxine
Given PO
Other Names:
  • Effexor
  • VNF

Other: questionnaire administration
Ancillary studies

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID beginning on day 1 of and continuing through completion of FOLFOX.
Drug: placebo
Given PO
Other Name: PLCB

Other: questionnaire administration
Ancillary studies

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment




Primary Outcome Measures :
  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 [ Time Frame: Up to 2 weeks ]
    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.


Secondary Outcome Measures :
  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) [ Time Frame: Up to 2 weeks ]
    The EORTC QLQ-CIPN20 motor and autonomic neuropathy scores 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 =< 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®)
    • 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 =< 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611155


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Charles Loprinzi Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01611155     History of Changes
Other Study ID Numbers: MC11C4
NCI-2012-00318 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 4, 2012    Key Record Dates
Results First Posted: September 26, 2019
Last Update Posted: September 26, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
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Neuromuscular Diseases
Serotonin and Noradrenaline Reuptake Inhibitors
Peripheral Nervous System Diseases
Nervous System Diseases
Oxaliplatin
Venlafaxine Hydrochloride
Antineoplastic Agents
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs