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NCT01598298 · ClinicalTrials.gov registry record · Phase 3
S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy
A Phase 3 study of Breast Cancer and Pain, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 299
- Enrollment target
- 20
- Study locations
NCT01598298: Completed Phase 3 study of Breast Cancer and Pain, sponsored by SWOG Cancer Research Network.
NCT01598298 is a Phase 3 study of Breast Cancer and Pain that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 299 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01598298, a Phase 3 study of Breast Cancer and Pain, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 299 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy. PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.
Primary Outcome
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".
Conditions Studied
Interventions
- OTHER placebo
- DRUG duloxetine hydrochloride
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Sutter Auburn Faith Hospital - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills - Peninsula Hospitals - Burlingame
- East Bay Radiation Oncology Center - Castro Valley
- Eden Hospital Medical Center - Castro Valley
- Valley Medical Oncology Consultants-Castro Valley - Castro Valley
- Sutter Davis Hospital - Davis
- Epic Care-Dublin - Dublin
- Bay Area Breast Surgeons Inc - Emeryville
- Epic Care Partners in Cancer Care - Emeryville
- Kaiser Permanente-Fremont - Fremont
- Valley Medical Oncology Consultants-Fremont - Fremont
- Kaiser Permanente - Fresno
Alaska
- Alaska Breast Care and Surgery LLC - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arkansas
- Fowler Family Center for Cancer Care - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2013-05-15 |
| Est. Completion | 2018-12-20 |
| Phase | Phase 3 |
What the finished NCT01598298 record still lists
NCT01598298 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01598298 names 20 study sites across 3 states, led by California, Alaska, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01598298 about?
NCT01598298 is a clinical study titled "S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy". RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy. PURPOSE: This randomized pha...
What is the current status of trial NCT01598298?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 299 participants. The study started on 2013-05-15. Estimated completion is 2018-12-20.
What conditions does trial NCT01598298 study?
This clinical trial studies the following conditions: Breast Cancer, Pain, Musculoskeletal Complications.
What interventions are being tested in trial NCT01598298?
The interventions under investigation include: placebo (OTHER), duloxetine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01598298?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01598298 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01598298's enrollment target sits among peer trials
299 288th of 1224 higher than 937 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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