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 : December 16, 2022
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Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm I: Duloxetine | Arm II: Placebo |
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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.
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Baseline Characteristics
Arm/Group Title | Arm I: Duloxetine | Arm II: Placebo | Total | |
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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 | |
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Eligible patients
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 145 participants | 144 participants | 289 participants | |
60
(40 to 83)
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60
(27 to 82)
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60
(27 to 83)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 145 participants | 144 participants | 289 participants | |
Female |
145 100.0%
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144 100.0%
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289 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 145 participants | 144 participants | 289 participants | |
Hispanic or Latino |
5 3.4%
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6 4.2%
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11 3.8%
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Not Hispanic or Latino |
140 96.6%
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137 95.1%
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277 95.8%
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Unknown or Not Reported |
0 0.0%
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1 0.7%
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1 0.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 145 participants | 144 participants | 289 participants | |
American Indian or Alaska Native |
0 0.0%
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2 1.4%
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2 0.7%
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Asian |
6 4.1%
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3 2.1%
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9 3.1%
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Native Hawaiian or Other Pacific Islander |
1 0.7%
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0 0.0%
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1 0.3%
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Black or African American |
10 6.9%
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17 11.8%
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27 9.3%
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White |
128 88.3%
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120 83.3%
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248 85.8%
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More than one race |
0 0.0%
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1 0.7%
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1 0.3%
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Unknown or Not Reported |
0 0.0%
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1 0.7%
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1 0.3%
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Baseline pain score
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 145 participants | 144 participants | 289 participants | |
4-6 |
110 75.9%
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110 76.4%
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220 76.1%
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7-10 |
35 24.1%
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34 23.6%
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69 23.9%
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[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.
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Prior taxane use
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 145 participants | 144 participants | 289 participants | |
No |
68 46.9%
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65 45.1%
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133 46.0%
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Yes |
77 53.1%
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79 54.9%
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156 54.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
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):
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: | December 16, 2022 |