Trial · NCT01313117
Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy
NCT01313117, Phase 1, Phase 2, Completed, Northwestern University; results first posted 2014-10-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy. Trials, record NCT01313117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01313117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy
- NCT number
- NCT01313117
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Peripheral Neuropathy
- Interventions
- Alpha lipoic acid
- First posted
- 2011-03-11
- Last updated
- 2014-10-02
- Results first posted
- 2014-10-02
- Limitations and caveats
- The small number of enrolled patients precluded any meaningful ALA dose finding or neuropathy prevention efficacy statements. A formal statistical analysis of the data was not able to be performed.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile | 4 months | Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation. |
| Secondary | Proportion of Patients Who Complete the Proposed Regimen of Daily ALA | 4 months | |
| Secondary | Cumulative Rate of Adverse Events | 4 months | |
| Secondary | Total Neuropathy Score (TNS) | 4 months | The Total Neuropathy score (TNS) is a validated score that combines signs, symptoms, and very limited nerve conduction studies (NCS). It was designed to assess peripheral nerve function and has been used as an endpoint in clinical trials of toxic neuropathy. The TNS is a composite scale with a range of values from 0 (normal) to 28 (severely affected). It includes data from 7 different categories. Patients are asked to assess the severity of sensory symptoms on a scale of 0 (no symptoms) to 4 (symptoms above knees or elbows, or functionally disabling). Next, 4 examination categories are assessed. These include pin sensation, vibration sensation, deep tendon reflexes, and strength. Signs are scored from 0 to 4 depending on severity. The nerve conduction portion of the scale consists of measurements of a motor (peroneal) and sensory (sural) nerve. Motor and sensory responses are graded on a scale of 0 to 4 depending on the severity of an abnormality. |
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 | Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile | 4 months | Although our dose finding analysis suggested a maximum tolerated dose of 500mg daily, it should be noted that we failed to fully complete the Continual Reassessment Method (CRM) dose finding portion of the study. As such, we can not make confident dose finding statements on the basis of this trial. | mg | NUMBER |
| SECONDARY | Proportion of Patients Who Complete the Proposed Regimen of Daily ALA | 4 months | participants | NUMBER | |
| SECONDARY | Cumulative Rate of Adverse Events | 4 months | participants | NUMBER | |
| SECONDARY | Total Neuropathy Score (TNS) | 4 months | Failure to reach the MTD precluded our ability to perform any meaningful analysis of the TNS. |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile | Alpha Lipoic Acid | 500 | mg | ||
| Proportion of Patients Who Complete the Proposed Regimen of Daily ALA | Alpha Lipoic Acid | 7 | participants | ||
| Cumulative Rate of Adverse Events | Alpha Lipoic Acid | 9 | participants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort 1: Dose Level 1 (ALA 300mg Daily) | STARTED | Alpha Lipoic Acid | 2 | |
| Cohort 1: Dose Level 1 (ALA 300mg Daily) | COMPLETED | Alpha Lipoic Acid | 2 | |
| Cohort 1: Dose Level 1 (ALA 300mg Daily) | NOT COMPLETED | Alpha Lipoic Acid | 0 | |
| Cohort 2: Dose Level 2 (ALA 600mg Daily) | STARTED | Alpha Lipoic Acid | 2 | |
| Cohort 2: Dose Level 2 (ALA 600mg Daily) | COMPLETED | Alpha Lipoic Acid | 1 | |
| Cohort 2: Dose Level 2 (ALA 600mg Daily) | NOT COMPLETED | Alpha Lipoic Acid | 1 | |
| Cohort 3: Dose Level 3 (ALA 400mg Daily) | STARTED | Alpha Lipoic Acid | 2 | |
| Cohort 3: Dose Level 3 (ALA 400mg Daily) | COMPLETED | Alpha Lipoic Acid | 2 | |
| Cohort 3: Dose Level 3 (ALA 400mg Daily) | NOT COMPLETED | Alpha Lipoic Acid | 0 | |
| Cohort 4: Dose Level 4 (ALA 500mg Daily) | STARTED | Alpha Lipoic Acid | 2 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events5
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 | Nausea | Gastrointestinal disorders | Alpha Lipoic Acid | 3 | 9 | 3 |
| other | Rash | Skin and subcutaneous tissue disorders | Alpha Lipoic Acid | 3 | 9 | 3 |
| other | Indigestion | Gastrointestinal disorders | Alpha Lipoic Acid | 1 | 9 | 1 |
| other | Constipation | Gastrointestinal disorders | Alpha Lipoic Acid | 1 | 9 | 1 |
| other | Pain | Gastrointestinal disorders | Alpha Lipoic Acid | 1 | 9 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alpha Lipoic Acid | ||
| Total, other adverse events | Alpha Lipoic Acid | 9 | 9 |
| Total, serious adverse events | Alpha Lipoic Acid | 0 | 9 |
Source ClinicalTrials.gov
Papers13
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01313117
GET https://conductscience.org/api/trials/v1/NCT01313117/registered