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A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

Phase 3
25 Years
Open (Enrolling)
Neurotoxicity Syndromes, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy



- Determine the efficacy of duloxetine hydrochloride in cancer patients with painful
chemotherapy-induced (taxane or platinum agent) peripheral neuropathy.


- Determine the influence of this drug on peripheral neuropathy-related functional status
and quality of life of these patients.

- Describe the differences in duloxetine hydrochloride efficacy when used to treat pain
caused by chemotherapy-induced peripheral neuropathy based on the neurotoxic drug and

OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients
are stratified according to prior neurotoxic agent (paclitaxel vs oxaliplatin vs other
taxane agents without paclitaxel vs platinum agents [cisplatin] without oxaliplatin) and
high risk for developing painful chemotherapy-induced peripheral neuropathy (no vs yes).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6.
After a 1-week rest period, patients cross over to receive an oral placebo once or
twice daily in weeks 8-13.

- Arm II: Patients receive an oral placebo once or twice daily in weeks 1-6. After a
1-week rest period, patients cross over to receive oral duloxetine hydrochloride once
or twice daily in weeks 8-13.

Patients complete pain and quality of life questionnaires, including the BPI-SF once weekly
and FACT/GOG-NTX and EORTC QLQ-C30 questionnaires, in weeks 1, 6, 8, and 13.

After completion of study treatment, patients are followed for 2 weeks.

Inclusion Criteria


- Diagnosis of cancer

- CNS malignancy allowed with the exception of leptomeningeal carcinomatosis

- Must have painful sensory chemotherapy-induced peripheral neuropathy (CIPN) resulting
from prior treatment with single-agent taxane or platinum agents (paclitaxel,
docetaxel, nab-paclitaxel, oxaliplatin, cisplatin) (may not have received drugs from
both classes)

- CIPN > grade 1 as measured by NCI-CTCAE v 4.0

- Average neuropathic pain score ≥ 4

- Patients with the following illnesses known to cause peripheral neuropathy are
eligible, provided they have no evidence of neuropathy from these illnesses:

- Diabetes mellitus

- Peripheral vascular disease

- HIV infection

- Significant degenerative or familial neurologic disorder known to cause
peripheral neuropathy

- No clinical or subclinical neuropathy from nerve compression injuries (i.e., carpal
tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root


- AST ≤ 3 times upper limit of normal

- Total bilirubin ≤ normal

- Creatinine clearance > 30 mL/min

- Not pregnant or nursing

- Able to take oral or enteral medication

- No history of seizure disorder

- No diagnosis of ethanol addiction or dependence within the past 10 years

- No history of narrow-angle glaucoma

- None of the following:

- History of suicidal thoughts

- Symptoms of or history of schizophrenia, bipolar disease, or a major depression

- Serious eating disorder such as bulimia or anorexia where electrolyte imbalance
is likely


- At least 3 months since prior and no concurrent taxane or platinum agent

- At least 14 days since prior and no concurrent monoamine oxidase inhibitors or other

- No other prior or concurrent neurotoxic drugs (e.g., vincristine, vinblastine,
cytarabine, thalidomide, bortezomib, carboplatin, or procarbazine)

- No concurrent anticonvulsants

- No concurrent B or E vitamin supplementation in doses greater than the recommended
daily allowance (RDA)

- Centrum (standard formula) and One-A-Day "essential" formula which contain 100%
RDA for vitamins B6, E, and B12 allowed

- Other multivitamins allowed provided they contain no more than 100% RDA of B
vitamins and vitamin E

- No concurrent treatment (pharmacologic) for depression

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Average pain as measured by the BPI-SF

Principal Investigator

Ellen L. Smith, PhD, ARNP, AOCN

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan


United States: Federal Government

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Neurotoxicity Syndromes
  • Pain
  • Peripheral Neuropathy
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • neurotoxicity
  • pain
  • peripheral neuropathy
  • Peripheral Nervous System Diseases
  • Neurotoxicity Syndromes
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations



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Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Vince Lombardi Cancer Clinic - Sheboygan Sheboygan, Wisconsin  53081
Marshfield Clinic at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Aurora Medical Center Summit, Wisconsin  53066
Vince Lombardi Cancer Clinic - Two Rivers Two Rivers, Wisconsin  54241
Aurora Health Center - Waukesha Waukesha, Wisconsin  53188
Marshfield Clinic - Wausau Center Wausau, Wisconsin  54401
Oncology Alliance, SC - Milwaukee - West Wauwatosa, Wisconsin  53226
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Rocky Mountain Oncology Casper, Wyoming  82609
Cancer Resource Center at King's Daughters Medical Center Ashland, Kentucky  41101
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois  60612-9985
Aurora Sinai Medical Center Milwaukee, Wisconsin  53201-0342
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Martha Jefferson Hospital Cancer Care Center Charlottesville, Virginia  22901
Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc, Wisconsin  53066
Harold Alfond Center for Cancer Care Augusta, Maine  04330
Kinston Medical Specialists Kinston, North Carolina  28501
Greenville Hospital Cancer Center Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Grove Commons Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris Road Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas - Seneca Seneca, South Carolina  29672
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Glendale Memorial Hospital Comprehensive Cancer Center Glendale, California  91204
Resurrection Medical Center Chicago, Illinois  60631
McLeod Regional Medical Center Florence, South Carolina  29501
Nalitt Cancer Institute at Staten Island University Hospital Staten Island, New York  10305
La Grange Memorial Hospital La Grange, Illinois  60525
Lakes Region General Hospital Laconia, New Hampshire  03246
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland, New Jersey  08360
Cancer Center at Phoenixville Hospital Phoenixville, Pennsylvania  19460
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
El Camino Hospital Cancer Center Mountain View, California  94040
Larry G Strieff MD Medical Corporation Oakland, California  94609
Tom K Lee, Incorporated Oakland, California  94609
Bay Area Breast Surgeons, Incorporated Oakland, California  94609
Illinois CancerCare - Bloomington Bloomington%, Illinois  61701
Illinois CancerCare - Canton Canton, Illinois  61520
Illinois CancerCare - Carthage Carthage, Illinois  62321
Elmhurst Memorial Hospital Elmhurst, Illinois  60126
Illinois CancerCare - Eureka Eureka, Illinois  61530
Illinois CancerCare - Galesburg Galesburg, Illinois  61401
Illinois CancerCare - Havana Havana, Illinois  62644
Illinois CancerCare - Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare - Macomb Macomb, Illinois  61455
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
OSF Holy Family Medical Center Monmouth, Illinois  61462
Illinois CancerCare - Monmouth Monmouth, Illinois  61462
Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
Illinois CancerCare - Pekin Pekin, Illinois  61603
Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Illinois CancerCare - Spring Valley Spring Valley, Illinois  61362
Iowa Blood and Cancer Care Cedar Rapids, Iowa  52402
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord, New Hampshire  03301
Center for Cancer Care at Exeter Hospital Exeter, New Hampshire  03833
New Hampshire Oncology - Hematology, PA - Hooksett Hooksett, New Hampshire  03106
Trinity CancerCare Center Minot, North Dakota  58701
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Bay Area Hospital Coos Bay, Oregon  97420
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
Fountain Valley, California  92708
St. Anthony's Cancer Center St. Louis, Missouri  63128
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Cleveland Clinic Florida - Weston Weston, Florida  33331
High Point Regional Hospital High Point, North Carolina  27261
CaroMont Cancer Center at Gaston Memorial Hospital Gastonia, North Carolina  28053
Valley Medical Oncology Consultants - Castro Valley Castro Valley, California  94546
Valley Medical Oncology Fremont, California  94538
Mercy Regional Cancer Center Janesville, Wisconsin  53547
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
Self Regional Cancer Center at Self Regional Medical Center Greenwood, South Carolina  29646
Shore Regional Cancer Center at Memorial Hospital - Easton Easton, Maryland  21601
Camino Medical Group - Treatment Center Mountain View, California  94040
New York Oncology Hematology, PC at Albany Regional Cancer Care Albany, New York  12208
Amsterdam Community Cancer Program Amsterdam, New York  12010
Riverview Cancer Care Medical Associates, PC Rexford, New York  12148
Samaritan Hospital at Northeast Health Troy, New York  12180
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Martinsville, Virginia  24115
Kaiser Permanente - Division of Research - Oakland Oakland, California  94611
Kaiser Permanente Medical Center - Rancho Cordova Rancho Cordova, California  95670
Rohnert Park Cancer Center Rohnert Park, California  94928
South Sacramento Cancer Center Sacramento, California  95823
Aurora Women's Pavilion of West Allis Memorial Hospital West Allis, Wisconsin  53227
New York Oncology Hematology, PC at Albany Medical Center Albany, New York  12208
New York Oncology Hematology, PC - Hudson Hudson, New York  12534
Bendheim Cancer Center at Greenwich Hospital Greenwich, Connecticut  06830
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin  54904
Central Dupage Cancer Center Warrenville, Illinois  60555
Comprehensive Cancer Care, PC Saint Louis, Missouri  63141
New York Oncology Hematology, PC - Latham Latham, New York  12110
Doylestown Hospital Cancer Center Doylestown, Pennsylvania  18901
Waverly Hematology Oncology Cary, North Carolina  27518
Dickstein Cancer Treatment Center at White Plains Hospital Center White Plains, New York  10601
Kaiser Permanente Medical Center - Vacaville Vacaville, California  95688
Emerywood Hematology/Oncology High Point, North Carolina  27262