Trial · NCT00489411
Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
NCT00489411, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer. Trials, record NCT00489411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00489411
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
- NCT number
- NCT00489411
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 231 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Neurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- duloxetine hydrochloride, placebo
- First posted
- 2007-06-21
- Last updated
- 2017-04-26
- Results first posted
- 2017-04-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item | Day 1 of Week 1 to Day 1 of Week 6 | 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. |
| Secondary | 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 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item | Day 1 of Week 1 to Day 1 of Week 6 | 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. | units on a scale | MEAN |
| SECONDARY | 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 | 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. | units on a scale | MEAN |
| SECONDARY | 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 | 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. | units on a scale | MEAN |
| SECONDARY | 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 | Patients who completed crossover intervention and had complete data were included in the analysis. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item | Arm I/Group A (Duloxetine Then Placebo) | 1.06 | 95% Confidence Interval 0.72 to 1.40 | units on a scale | |
| Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item | Arm II/Group B (Placebo Then Duloxetine) | 0.34 | 95% Confidence Interval 0.01 to 0.66 | units on a scale | |
| Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score | Arm I/Group A (Duloxetine Then Placebo) | 7.9 | 95% Confidence Interval 5.4 to 10.5 | units on a scale | |
| Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score | Arm II/Group B (Placebo Then Duloxetine) | 3.5 | 95% Confidence Interval 1.1 to 5.9 | units on a scale | |
| Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5 | Arm I/Group A (Duloxetine Then Placebo) | 2.44 | 95% Confidence Interval 0.43 to 4.45 | units on a scale | |
| Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5 | Arm II/Group B (Placebo Then Duloxetine) | 0.87 | 95% Confidence Interval -1.09 to 2.82 | units on a scale | |
| Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item | Arm I/Group A (Duloxetine Then Placebo) | 0.41 | 95% Confidence Interval 0.06 to 0.89 | units on a scale | |
| Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item | Arm II/Group B (Placebo Then Duloxetine) | 1.42 | 95% Confidence Interval 0.97 to 1.87 | units on a scale |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment Period (Weeks 1-5) | STARTED | Arm I/Group A (Duloxetine Then Placebo) | 115 | |
| Initial Treatment Period (Weeks 1-5) | STARTED | Arm II/Group B (Placebo Then Duloxetine) | 116 | |
| Initial Treatment Period (Weeks 1-5) | COMPLETED | Arm I/Group A (Duloxetine Then Placebo) | 87 | |
| Initial Treatment Period (Weeks 1-5) | COMPLETED | Arm II/Group B (Placebo Then Duloxetine) | 94 | |
| Initial Treatment Period (Weeks 1-5) | NOT COMPLETED | Arm I/Group A (Duloxetine Then Placebo) | 28 | |
| Initial Treatment Period (Weeks 1-5) | NOT COMPLETED | Arm II/Group B (Placebo Then Duloxetine) | 22 | |
| Washout Period (Weeks 6-7) | STARTED | Arm I/Group A (Duloxetine Then Placebo) | 87 | |
| Washout Period (Weeks 6-7) | STARTED | Arm II/Group B (Placebo Then Duloxetine) | 94 | |
| Washout Period (Weeks 6-7) | COMPLETED | Arm I/Group A (Duloxetine Then Placebo) | 85 | |
| Washout Period (Weeks 6-7) | COMPLETED | Arm II/Group B (Placebo Then Duloxetine) | 93 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events188
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I/Group A (Duloxetine Then Placebo) | 1 | 108 | 1 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II/Group B (Placebo Then Duloxetine) | 1 | 107 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Arm I/Group A (Duloxetine Then Placebo) | 0 | 108 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Arm II/Group B (Placebo Then Duloxetine) | 1 | 107 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Arm I/Group A (Duloxetine Then Placebo) | 1 | 108 | 2 |
| other | Tinnitus | Ear and labyrinth disorders | Arm II/Group B (Placebo Then Duloxetine) | 0 | 107 | 0 |
| other | Eye disorder | Eye disorders | Arm I/Group A (Duloxetine Then Placebo) | 0 | 108 | 0 |
| other | Eye disorder | Eye disorders | Arm II/Group B (Placebo Then Duloxetine) | 1 | 107 | 4 |
| other | Vision blurred | Eye disorders | Arm I/Group A (Duloxetine Then Placebo) | 2 | 108 | 2 |
| other | Vision blurred | Eye disorders | Arm II/Group B (Placebo Then Duloxetine) | 0 | 107 | 0 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I/Group A (Duloxetine Then Placebo) | ||
| Total, all-cause mortality | Arm II/Group B (Placebo Then Duloxetine) | ||
| Total, other adverse events | Arm I/Group A (Duloxetine Then Placebo) | 93 | 108 |
| Total, other adverse events | Arm II/Group B (Placebo Then Duloxetine) | 91 | 107 |
| Total, serious adverse events | Arm I/Group A (Duloxetine Then Placebo) | 1 | 108 |
| Total, serious adverse events | Arm II/Group B (Placebo Then Duloxetine) | 3 | 107 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I/Group A (Duloxetine Then Placebo) vs Arm II/Group B (Placebo Then Duloxetine): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00489411
GET https://conductscience.org/api/trials/v1/NCT00489411/events?page=2