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Trial record 13 of 89 for:    "Neuromuscular Disease" | "Norepinephrine"

Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00489411
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Neurotoxicity
Pain
Peripheral Neuropathy
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: duloxetine hydrochloride
Other: placebo
Enrollment 231
Recruitment Details  
Pre-assignment Details The number of screened and the number offered participation but declined was not captured.
Arm/Group Title Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine)
Hide Arm/Group Description Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14). Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Period Title: Initial Treatment Period (Weeks 1-5)
Started 115 116
Completed 87 94
Not Completed 28 22
Reason Not Completed
Withdrew consent prior to intervention             6             5
Discontinued study drug early             21             12
Incomplete data             1             5
Period Title: Washout Period (Weeks 6-7)
Started 87 94
Completed [1] 85 93
Not Completed 2 1
[1]
Reasons for why patients did not participate in the crossover treatment period were not captured.
Period Title: Crossover Treatment Period (Weeks 8-12)
Started 85 93
Completed 67 74
Not Completed 18 19
Reason Not Completed
Discontinued intervention early             11             12
Incomplete data             7             7
Arm/Group Title Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine) Total
Hide Arm/Group Description Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14). Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14). Total of all reporting groups
Overall Number of Baseline Participants 109 111 220
Hide Baseline Analysis Population Description
All patients who received duloxetine/placebo as randomized were included in the analysis population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 111 participants 220 participants
60.0  (10.4) 59.0  (10.6) 59.0  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 111 participants 220 participants
Female
71
  65.1%
67
  60.4%
138
  62.7%
Male
38
  34.9%
44
  39.6%
82
  37.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 109 participants 111 participants 220 participants
109 111 220
1.Primary Outcome
Title Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item
Hide Description 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.
Time Frame Day 1 of Week 1 to Day 1 of Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.
Arm/Group Title Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine)
Hide Arm/Group Description:
Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Overall Number of Participants Analyzed 87 94
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.06
(0.72 to 1.40)
0.34
(0.01 to 0.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I/Group A (Duloxetine Then Placebo), Arm II/Group B (Placebo Then Duloxetine)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.26 to 1.20
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score
Hide Description Change in pain-related functional interference score during the initial treatment period (Week 1 to Week 5), as measured by the BPI-SF interference score: Using an accepted method for accessing the influence of pain on function, 7 BPI-SF items were used to quantify the degree to which pain interfered with daily activities or function (0, does not interfere; 10 completely interferes). The 7 items were summed to obtain a total interference score, which ranged from 0 to 70, with lower scores meaning less interference. The mean change in pain-related functional interference score during the initial treatment period are reported below for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.
Time Frame Day 1 of Week 1 to Day 1 to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.
Arm/Group Title Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine)
Hide Arm/Group Description:
Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Overall Number of Participants Analyzed 87 94
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
7.9
(5.4 to 10.5)
3.5
(1.1 to 5.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I/Group A (Duloxetine Then Placebo), Arm II/Group B (Placebo Then Duloxetine)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 4.40
Confidence Interval (2-Sided) 95%
0.93 to 7.88
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5
Hide Description Patient-reported QOL was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) subscale on day 1 of weeks 1, 6, 8, and 13. The instrument contains 11 questions, assessing numbness, tingling, and discomfort in the hands or feet; difficulty hearing; tinnitus; joint pain or muscle cramps; weakness; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0 to 4 (o, not at all; 4, very much) and summed (total score range, 0-44, with higher scores indicating a worse outcome). A 2- to 3-point change is defined as a clinically meaningful improvement in QOL per published recommendations specific to similar measures. The Mean Change During Initial Treatment Period in the FACT/GOG-Ntx total score are reported for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.
Time Frame Day 1 of Week 1 to Day 1 of Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.
Arm/Group Title Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine)
Hide Arm/Group Description:
Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Overall Number of Participants Analyzed 87 94
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.44
(0.43 to 4.45)
0.87
(-1.09 to 2.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I/Group A (Duloxetine Then Placebo), Arm II/Group B (Placebo Then Duloxetine)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 1.58
Confidence Interval (2-Sided) 95%
0.15 to 3.00
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item
Hide Description Change in average pain from Week 8 to Week 12, measured on day 1 of Weeks 8 and 13 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 8 minus value at Day 1 of Week 13 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 crossover treatment period.
Time Frame Day 1 of Week 8 to Day 1 of Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed crossover intervention and had complete data were included in the analysis.
Arm/Group Title Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine)
Hide Arm/Group Description:
Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Overall Number of Participants Analyzed 67 74
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.41
(0.06 to 0.89)
1.42
(0.97 to 1.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I/Group A (Duloxetine Then Placebo), Arm II/Group B (Placebo Then Duloxetine)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.36 to 1.65
Estimation Comments [Not Specified]
Time Frame Adverse events are assessed during weeks 1-15 of the study.
Adverse Event Reporting Description The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.
 
Arm/Group Title Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine)
Hide Arm/Group Description Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14). Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
All-Cause Mortality
Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/108 (0.93%)      3/107 (2.80%)    
Gastrointestinal disorders     
Diarrhea  1  0/108 (0.00%)  0 2/107 (1.87%)  2
Vomiting  1  0/108 (0.00%)  0 1/107 (0.93%)  1
General disorders     
Fatigue  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Injury, poisoning and procedural complications     
Vascular access complication  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Metabolism and nutrition disorders     
Anorexia  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Nervous system disorders     
Dizziness  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Headache  1  1/108 (0.93%)  1 1/107 (0.93%)  1
Peripheral sensory neuropathy  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Psychiatric disorders     
Insomnia  1  1/108 (0.93%)  1 1/107 (0.93%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I/Group A (Duloxetine Then Placebo) Arm II/Group B (Placebo Then Duloxetine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   93/108 (86.11%)      91/107 (85.05%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  1/108 (0.93%)  1 1/107 (0.93%)  1
Cardiac disorders     
Atrial fibrillation  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Ear and labyrinth disorders     
Tinnitus  1  1/108 (0.93%)  2 0/107 (0.00%)  0
Eye disorders     
Eye disorder  1  0/108 (0.00%)  0 1/107 (0.93%)  4
Vision blurred  1  2/108 (1.85%)  2 0/107 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Abdominal pain  1  1/108 (0.93%)  1 1/107 (0.93%)  1
Constipation  1  29/108 (26.85%)  84 32/107 (29.91%)  96
Diarrhea  1  28/108 (25.93%)  59 31/107 (28.97%)  103
Dry mouth  1  24/108 (22.22%)  116 27/107 (25.23%)  146
Dyspepsia  1  3/108 (2.78%)  3 1/107 (0.93%)  7
Esophagitis  1  0/108 (0.00%)  0 1/107 (0.93%)  4
Gastritis  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Nausea  1  50/108 (46.30%)  88 40/107 (37.38%)  82
Stomach pain  1  1/108 (0.93%)  1 1/107 (0.93%)  3
Vomiting  1  6/108 (5.56%)  6 4/107 (3.74%)  4
General disorders     
Chest pain  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Edema limbs  1  2/108 (1.85%)  6 1/107 (0.93%)  2
Fatigue  1  56/108 (51.85%)  205 50/107 (46.73%)  297
Fever  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Flu-like symptoms  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Irritability  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Pain  1  3/108 (2.78%)  9 3/107 (2.80%)  11
Infections and infestations     
Bladder infection  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Infection  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Peripheral nerve infection  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Pharyngitis  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Upper respiratory infection  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Urinary tract infection  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Injury, poisoning and procedural complications     
Wound dehiscence  1  1/108 (0.93%)  2 0/107 (0.00%)  0
Investigations     
Alkaline phosphatase increased  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Aspartate aminotransferase increased  1  1/108 (0.93%)  1 1/107 (0.93%)  1
Creatinine increased  1  2/108 (1.85%)  4 1/107 (0.93%)  1
Laboratory test abnormal  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Leukocyte count decreased  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Neutrophil count decreased  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Platelet count decreased  1  1/108 (0.93%)  2 1/107 (0.93%)  1
Serum cholesterol increased  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Metabolism and nutrition disorders     
Anorexia  1  16/108 (14.81%)  26 23/107 (21.50%)  83
Blood glucose increased  1  4/108 (3.70%)  7 2/107 (1.87%)  16
Dehydration  1  2/108 (1.85%)  3 1/107 (0.93%)  1
Serum albumin decreased  1  2/108 (1.85%)  2 1/107 (0.93%)  1
Serum magnesium decreased  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/108 (0.93%)  1 3/107 (2.80%)  30
Arthritis  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Back pain  1  0/108 (0.00%)  0 4/107 (3.74%)  9
Bone pain  1  1/108 (0.93%)  1 2/107 (1.87%)  11
Myalgia  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Pain in extremity  1  3/108 (2.78%)  20 7/107 (6.54%)  58
Nervous system disorders     
Ataxia  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Depressed level of consciousness  1  12/108 (11.11%)  33 23/107 (21.50%)  69
Dizziness  1  24/108 (22.22%)  56 19/107 (17.76%)  49
Dysgeusia  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Extrapyramidal disorder  1  0/108 (0.00%)  0 1/107 (0.93%)  5
Headache  1  29/108 (26.85%)  74 28/107 (26.17%)  97
Memory impairment  1  1/108 (0.93%)  2 0/107 (0.00%)  0
Neuralgia  1  5/108 (4.63%)  22 3/107 (2.80%)  17
Peripheral motor neuropathy  1  3/108 (2.78%)  14 3/107 (2.80%)  26
Peripheral sensory neuropathy  1  21/108 (19.44%)  166 26/107 (24.30%)  205
Syncope  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Syncope vasovagal  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Psychiatric disorders     
Agitation  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Anxiety  1  1/108 (0.93%)  1 1/107 (0.93%)  2
Depression  1  2/108 (1.85%)  2 1/107 (0.93%)  1
Insomnia  1  39/108 (36.11%)  167 40/107 (37.38%)  223
Renal and urinary disorders     
Glomerular filtration rate decreased  1  2/108 (1.85%)  5 0/107 (0.00%)  0
Urinary frequency  1  1/108 (0.93%)  1 1/107 (0.93%)  1
Reproductive system and breast disorders     
Breast pain  1  1/108 (0.93%)  1 2/107 (1.87%)  2
Ejaculation disorder  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Erectile dysfunction  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Dyspnea  1  0/108 (0.00%)  0 1/107 (0.93%)  2
Pharyngolaryngeal pain  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Voice alteration  1  1/108 (0.93%)  1 1/107 (0.93%)  1
Skin and subcutaneous tissue disorders     
Dry skin  1  1/108 (0.93%)  1 0/107 (0.00%)  0
Erythema multiforme  1  1/108 (0.93%)  4 0/107 (0.00%)  0
Pruritus  1  1/108 (0.93%)  1 2/107 (1.87%)  2
Rash acneiform  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Rash desquamating  1  1/108 (0.93%)  1 2/107 (1.87%)  2
Sweating  1  2/108 (1.85%)  2 3/107 (2.80%)  5
Vascular disorders     
Flushing  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Hot flashes  1  4/108 (3.70%)  13 4/107 (3.74%)  23
Hypertension  1  2/108 (1.85%)  2 3/107 (2.80%)  7
Hypotension  1  0/108 (0.00%)  0 1/107 (0.93%)  2
Vascular disorder  1  0/108 (0.00%)  0 1/107 (0.93%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ellen Lavoie Smith, PhD, APRN, AOCN, FAAN
Organization: University of Michigan School of Nursing
Phone: 734-936-1267
EMail: Ellenls@med.umich.edu
Publications of Results:
Lavoie Smith EM, Pang H, Cirrincione C, et al.: CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN). [Abstract] J Clin Oncol 30 (Suppl 15): A-CRA9013, 2012.
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00489411     History of Changes
Other Study ID Numbers: CALGB-170601
CALGB-170601
CDR0000553389 ( Registry Identifier: NCI Physician Data Query )
First Submitted: June 20, 2007
First Posted: June 21, 2007
Results First Submitted: December 2, 2016
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017