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S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy

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ClinicalTrials.gov Identifier: NCT01598298
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : February 28, 2018
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Breast Cancer
Musculoskeletal Complications
Pain
Interventions Drug: duloxetine hydrochloride
Other: placebo
Enrollment 299
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I: Duloxetine Arm II: Placebo
Hide Arm/Group Description

Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.

duloxetine hydrochloride: Given PO

Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

placebo: Given PO
Period Title: Overall Study
Started 150 149
Patients Evaluable for Primary Endpoint [1] 127 128
Patients Evaluable for Adverse Events 138 141
Completed 110 108
Not Completed 40 41
Reason Not Completed
Not eligible             5             5
Adverse Event             21             19
Progression/relapse             0             2
Withdrawal by Subject             10             15
Other reason (not protocol specified)             4             0
[1]
Patient has an in-window BPI assessment at week 2, 6, or 12.
Arm/Group Title Arm I: Duloxetine Arm II: Placebo Total
Hide Arm/Group Description

Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.

duloxetine hydrochloride: Given PO

Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

placebo: Given PO

 Total of all reporting groups
Overall Number of Baseline Participants 145 144 289
Hide Baseline Analysis Population Description
Eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 145 participants 144 participants 289 participants
60
(40 to 83)
60
(27 to 82)
60
(27 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 144 participants 289 participants
Female
145
 100.0%
144
 100.0%
289
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 144 participants 289 participants
Hispanic or Latino
5
   3.4%
6
   4.2%
11
   3.8%
Not Hispanic or Latino
140
  96.6%
137
  95.1%
277
  95.8%
Unknown or Not Reported
0
   0.0%
1
   0.7%
1
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 144 participants 289 participants
American Indian or Alaska Native
0
   0.0%
2
   1.4%
2
   0.7%
Asian
6
   4.1%
3
   2.1%
9
   3.1%
Native Hawaiian or Other Pacific Islander
1
   0.7%
0
   0.0%
1
   0.3%
Black or African American
10
   6.9%
17
  11.8%
27
   9.3%
White
128
  88.3%
120
  83.3%
248
  85.8%
More than one race
0
   0.0%
1
   0.7%
1
   0.3%
Unknown or Not Reported
0
   0.0%
1
   0.7%
1
   0.3%
Baseline pain score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 144 participants 289 participants
4-6
110
  75.9%
110
  76.4%
220
  76.1%
7-10
35
  24.1%
34
  23.6%
69
  23.9%
[1]
Measure Description: Baseline pain score is the patient's self-reported average pain at baseline as measured by the BPI-SF question, "Please rate your joint pain by selecting the one number that best describes your joint pain on the AVERAGE". This score ranges from 0 to 10, with higher scores indicating more pain.
Prior taxane use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 144 participants 289 participants
No
68
  46.9%
65
  45.1%
133
  46.0%
Yes
77
  53.1%
79
  54.9%
156
  54.0%
1.Primary Outcome
Title Average Joint Pain According to BPI-SF
Hide Description Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".
Time Frame Weeks 2, 6, 12, and 24; Week 12 reported
Hide Outcome Measure Data
Hide Analysis Population Description
Patients evaluable for primary endpoint
Arm/Group Title Arm I: Duloxetine Arm II: Placebo
Hide Arm/Group Description:

Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.

duloxetine hydrochloride: Given PO

Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

placebo: Given PO
Overall Number of Participants Analyzed 127 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.9  (2.1) 3.5  (2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: Duloxetine, Arm II: Placebo
Comments The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for the stratification factors.
Type of Statistical Test Other
Comments Two-sided test at the alpha=0.05 level
Statistical Test of Hypothesis P-Value 0.0002
Comments Two-sided p-value; alpha=0.05
Method Mixed Models Analysis
Comments Adjusted for the protocol-specified stratification factors (baseline average pain and prior taxane use)
Method of Estimation Estimation Parameter Coefficient for treatment term
Estimated Value -0.82
Confidence Interval (2-Sided) 95%
-1.24 to -0.40
Estimation Comments The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.
2.Secondary Outcome
Title Worst Joint Pain According to the BPI-SF
Hide Description Worst joint pain according to the BPI-SF worst pain score (item #2). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".
Time Frame Weeks 2, 6, 12, and 24; Week 12 reported
Hide Outcome Measure Data
Hide Analysis Population Description
Patients evaluable for primary endpoint
Arm/Group Title Arm I: Duloxetine Arm II: Placebo
Hide Arm/Group Description:

Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.

duloxetine hydrochloride: Given PO

Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

placebo: Given PO
Overall Number of Participants Analyzed 127 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.0  (2.8) 4.9  (2.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: Duloxetine, Arm II: Placebo
Comments The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline worst pain score and the stratification factors.
Type of Statistical Test Other
Comments Two-sided test at the alpha=0.05 level
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided p-value; alpha=0.05
Method Mixed Models Analysis
Comments Adjusted for baseline worst pain score and the protocol-specified stratification factors (baseline average pain and prior taxane use).
Method of Estimation Estimation Parameter Coefficient for treatment term
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-1.57 to -0.55
Estimation Comments The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.
3.Secondary Outcome
Title Pain Interference According to the BPI-SF
Hide Description Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating "Does not interfere" and 10 indicating "Completely interferes".
Time Frame Weeks 2, 6, 12, and 24; Week 12 reported
Hide Outcome Measure Data
Hide Analysis Population Description
Patients evaluable for primary endpoint
Arm/Group Title Arm I: Duloxetine Arm II: Placebo
Hide Arm/Group Description:

Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.

duloxetine hydrochloride: Given PO

Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.

placebo: Given PO
Overall Number of Participants Analyzed 127 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.9  (2.2) 2.6  (2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I: Duloxetine, Arm II: Placebo
Comments The primary analysis will rely on longitudinal measures of pain interference scores at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline pain interference score and the stratification factors.
Type of Statistical Test Other
Comments Two-sided test at the alpha=0.05 level
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided p-value; alpha=0.05
Method Mixed Models Analysis
Comments Adjusted for baseline pain interference score and the protocol-specified stratification factors (baseline average pain and prior taxane use).
Method of Estimation Estimation Parameter Coefficient fro treatment term
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-1.35 to -0.55
Estimation Comments The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.
Time Frame Up to 24 weeks
Adverse Event Reporting Description Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
 
Arm/Group Title Arm II: Placebo Arm I: Duloxetine
Hide Arm/Group Description Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91. placebo: Given PO Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO
All-Cause Mortality
Arm II: Placebo Arm I: Duloxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/141 (0.00%)   0/138 (0.00%) 
Hide Serious Adverse Events
Arm II: Placebo Arm I: Duloxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/141 (0.00%)   0/138 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm II: Placebo Arm I: Duloxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   83/141 (58.87%)   115/138 (83.33%) 
Ear and labyrinth disorders     
Vertigo †  6/141 (4.26%)  10/138 (7.25%) 
Gastrointestinal disorders     
Abdominal pain †  6/141 (4.26%)  11/138 (7.97%) 
Constipation †  9/141 (6.38%)  23/138 (16.67%) 
Diarrhea †  10/141 (7.09%)  21/138 (15.22%) 
Dry mouth †  20/141 (14.18%)  38/138 (27.54%) 
Nausea †  12/141 (8.51%)  47/138 (34.06%) 
Vomiting †  2/141 (1.42%)  7/138 (5.07%) 
General disorders     
Fatigue †  25/141 (17.73%)  52/138 (37.68%) 
Flu like symptoms †  1/141 (0.71%)  12/138 (8.70%) 
Pain †  23/141 (16.31%)  27/138 (19.57%) 
Metabolism and nutrition disorders     
Anorexia †  3/141 (2.13%)  13/138 (9.42%) 
Musculoskeletal and connective tissue disorders     
Arthralgia †  26/141 (18.44%)  31/138 (22.46%) 
Joint range of motion decreased †  13/141 (9.22%)  15/138 (10.87%) 
Myalgia †  18/141 (12.77%)  32/138 (23.19%) 
Pain in extremity †  5/141 (3.55%)  8/138 (5.80%) 
Nervous system disorders     
Dizziness †  5/141 (3.55%)  20/138 (14.49%) 
Headache †  30/141 (21.28%)  35/138 (25.36%) 
Lethargy †  1/141 (0.71%)  9/138 (6.52%) 
Paresthesia †  10/141 (7.09%)  7/138 (5.07%) 
Somnolence †  4/141 (2.84%)  14/138 (10.14%) 
Tremor †  0/141 (0.00%)  11/138 (7.97%) 
Psychiatric disorders     
Agitation †  7/141 (4.96%)  10/138 (7.25%) 
Insomnia †  12/141 (8.51%)  22/138 (15.94%) 
Respiratory, thoracic and mediastinal disorders     
Cough †  6/141 (4.26%)  8/138 (5.80%) 
Nasal congestion †  8/141 (5.67%)  7/138 (5.07%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis †  5/141 (3.55%)  13/138 (9.42%) 
Vascular disorders     
Hot flashes †  22/141 (15.60%)  33/138 (23.91%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leukemia Committee Statistician
Organization: SWOG Statistics and Data Management Center
Phone: 2066674623
EMail: amoseley@fredhutch.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01598298    
Other Study ID Numbers: S1202
S1202 ( Other Identifier: SWOG )
U10CA037429 ( U.S. NIH Grant/Contract )
NCI-2012-01960 ( Other Identifier: NCI )
First Submitted: May 11, 2012
First Posted: May 15, 2012
Results First Submitted: January 31, 2018
Results First Posted: February 28, 2018
Last Update Posted: January 7, 2020