Trial · NCT00516503
Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
NCT00516503, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer. Trials, record NCT00516503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00516503
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
- NCT number
- NCT00516503
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 208 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Neurotoxicity, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- baclofen/amitriptyline/ketamine gel, placebo
- First posted
- 2007-08-15
- Last updated
- 2017-08-24
- Results first posted
- 2017-08-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20] | From baseline to 4 weeks | The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom. The primary analysis was the change in sensory neuropathy subscale of the CIPN-20 from baseline to week 4. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's sensory neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test. |
| Secondary | Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 | From Baseline to week 4 | The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the motor neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test. |
| Secondary | Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 | Up to 4 weeks | The scoring algorithm for the parent instrument, the EORTC QLQ-C30, was applied for linearly converting items and subscales of CIPN-20 to 0-100 scales so that a high score corresponds to better condition or less symptom. The secondary analysis was to compare changes from baseline at 4 weeks for the autonomic neuropathy subscale of the CIPN-20. To analyze this endpoint, the area under the curve (AUC) from baseline to week 4 was calculated for each patient's motor neuropathy score. The average AUC for the placebo arm was compared to the average AUC for the topical amitriptyline HCl/ baclofen/ ketamine arm using a Wilcoxon rank sum test. |
| Secondary | Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS) | At 4 weeks | Each mood scale (0 - 100, higher is better mood) will be analyzed as an endpoint along with the total mood disturbance score. |
| Secondary | Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4 | Up to 4 weeks | Pain severity, defined by the four items addressing worst, least, and average pain and pain right now as measured by the BPI will be analyzed identical to the primary endpoint. Additionally, total pain interference as measured by the BPI will be transformed onto a 0-100 ( higher is less pain) point scale. The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported. |
| Secondary | Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks | Up to 4 weeks | The Peripheral Neuropathy Questionnaire was used to analyze this endpoint. Patient neuropathy symptoms were scored on a 0 - 100 scale (higher score represents less symptomatic). The area under the curve (AUC) from baseline to week 4 was calculated for each patient's score. The average AUC for the placebo arm and the topical amitriptyline HCl/ baclofen/ ketamine arm are reported. |
| Secondary | Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0 | Up to 4 weeks | Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20] | From baseline to 4 weeks | There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons. | (units on a scale) * week | MEAN |
| SECONDARY | Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 | From Baseline to week 4 | There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse\> event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an\> adverse event, one patient died, and 18 refused for non-specified reasons. | (units on a scale)* week | MEAN |
| SECONDARY | Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 | Up to 4 weeks | There were 26 participants in the BAK arm and 27 in the placebo arm who did not provide primary endpoint data. In the BAK arm, 11 refused due to experiencing an adverse event and 15 refused for non-specified reasons. In the placebo arm, eight refused due to an adverse event, one patient died, and 18 refused for non-specified reasons. | (units on a scale)*week | MEAN |
| SECONDARY | Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS) | At 4 weeks | units on a scale | MEAN | |
| SECONDARY | Pain Severity and Interference as Measured by the Brief Pain Inventory (BPI) at Baseline and Week 4 | Up to 4 weeks | units on a scale * week | MEAN | |
| SECONDARY | Numbness, Tingling, and Pain as Measured by the Peripheral Neuropathy Questionnaire at Baseline and Weekly for 4 Weeks | Up to 4 weeks | units on a scale * week | MEAN | |
| SECONDARY | Adverse Event Profile of Topical Amitriptyline HCl/ Baclofen/Ketamine > Frequency and Severity of Adverse Events Reported by the Patient in the > Symptom Experience Diary and Evaluated Through Clinical Assessment by NCI CTCAE v3.0 | Up to 4 weeks | All patients that were assessed for adverse events are used in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20] | Baclofen-amitriptyline Hydrochloride-ketamine | 61.0 | Standard Deviation 16.22 | (units on a scale) * week | |
| Total Sensory Neuropathy as Measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life [QLQ] - Chemo-induced Peripheral Neuropathy [CIPN20] | Placebo | 60.9 | Standard Deviation 17.9 | (units on a scale) * week | |
| Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 | Baclofen-amitriptyline Hydrochloride-ketamine | 69.2 | Standard Deviation 17.15 | (units on a scale)* week | |
| Motor Neuropathy as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 | Placebo | 70.1 | Standard Deviation 19.48 | (units on a scale)* week | |
| Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 | Baclofen-amitriptyline Hydrochloride-ketamine | 85.0 | Standard Deviation 15.47 | (units on a scale)*week | |
| Autonomic Symptoms and Functioning as Measured by the EORTC QLQ-CIPN20 at Baseline and Week 4 | Placebo | 86.8 | Standard Deviation 15.03 | (units on a scale)*week | |
| Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS) | Baclofen-amitriptyline Hydrochloride-ketamine | POMS Tension-Anxiety Subscale | 83.2 | Standard Deviation 17.09 | units on a scale |
| Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS) | Placebo | POMS Tension-Anxiety Subscale | 83.0 | Standard Deviation 15.73 | units on a scale |
| Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS) | Baclofen-amitriptyline Hydrochloride-ketamine | POMS VA Subscale | 31.1 | Standard Deviation 18.42 | units on a scale |
| Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS) | Placebo | POMS VA Subscale | 33.0 | Standard Deviation 19.61 | units on a scale |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Baclofen-amitriptyline Hydrochloride-ketamine | 101 | |
| Overall Study | STARTED | Placebo | 102 | |
| Overall Study | COMPLETED | Baclofen-amitriptyline Hydrochloride-ketamine | 101 | |
| Overall Study | COMPLETED | Placebo | 102 | |
| Overall Study | NOT COMPLETED | Baclofen-amitriptyline Hydrochloride-ketamine | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events76
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 | Tinnitus | Ear and labyrinth disorders | Baclofen-amitriptyline Hydrochloride-ketamine | 0 | 101 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 1 | 102 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Baclofen-amitriptyline Hydrochloride-ketamine | 0 | 101 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 102 | 5 |
| other | Constipation | Gastrointestinal disorders | Baclofen-amitriptyline Hydrochloride-ketamine | 24 | 101 | 62 |
| other | Constipation | Gastrointestinal disorders | Placebo | 28 | 102 | 71 |
| other | Diarrhea | Gastrointestinal disorders | Baclofen-amitriptyline Hydrochloride-ketamine | 1 | 101 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 102 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Baclofen-amitriptyline Hydrochloride-ketamine | 18 | 101 | 55 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 23 | 102 | 55 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baclofen-amitriptyline Hydrochloride-ketamine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Baclofen-amitriptyline Hydrochloride-ketamine | 48 | 101 |
| Total, other adverse events | Placebo | 45 | 102 |
| Total, serious adverse events | Baclofen-amitriptyline Hydrochloride-ketamine | 1 | 101 |
| Total, serious adverse events | Placebo | 1 | 102 |
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 |
|---|
| Baclofen-amitriptyline Hydrochloride-ketamine vs Placebo: 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/NCT00516503
GET https://conductscience.org/api/trials/v1/NCT00516503/results?page=2