Brief Summary

RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

231

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Apr 2008

Longer than P75 for phase_3

Geographic Reach

1 country

475 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

First Submitted

Initial submission to the registry

June 20, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed

10 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed

4.2 years until next milestone

Results Posted

Study results publicly available

April 26, 2017

Completed

Last Updated

April 26, 2017

Status Verified

March 1, 2017

Enrollment Period

3.8 years

First QC Date

June 20, 2007

Results QC Date

December 2, 2016

Last Update Submit

March 16, 2017

Conditions

Neurotoxicity Pain Peripheral Neuropathy Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificneurotoxicitypainperipheral neuropathy

Outcome Measures

Primary Outcomes (1)

Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item
Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the initial treatment period.
Day 1 of Week 1 to Day 1 of Week 6

Secondary Outcomes (3)

Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score
Day 1 of Week 1 to Day 1 to Week 6
Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5
Day 1 of Week 1 to Day 1 of Week 6
Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item
Day 1 of Week 8 to Day 1 of Week 13

Study Arms (2)

Arm I/Group A (Duloxetine then Placebo)

EXPERIMENTAL

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.

Drug: duloxetine hydrochlorideOther: placebo

Arm II/Group B (Placebo then Duloxetine)

EXPERIMENTAL

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.

Drug: duloxetine hydrochlorideOther: placebo

Interventions

duloxetine hydrochlorideDRUG

Given orally

Arm I/Group A (Duloxetine then Placebo)Arm II/Group B (Placebo then Duloxetine)

placeboOTHER

Given orally

Arm I/Group A (Duloxetine then Placebo)Arm II/Group B (Placebo then Duloxetine)

Eligibility Criteria

Age25 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 compression) PATIENT CHARACTERISTICS: * 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 PRIOR CONCURRENT THERAPY: * 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 antidepressants * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (475)

Kaiser Permanente - Deer Valley

Antioch, California, 94531, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, 94524-4110, United States

Location

Kaiser Permanente - Fremont

Fremont, California, 94538, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, 91204, United States

Location

Kaiser Permanente Medical Center - Hayward

Hayward, California, 94545, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Camino Medical Group - Treatment Center

Mountain View, California, 94040, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus