Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01313117
Other study ID # NUALA-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 9, 2011
Last updated September 26, 2014
Start date February 2012
Est. completion date January 2014

Study information

Verified date September 2014
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is being done because peripheral neuropathy, a condition that interrupts sensation in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel. The purpose of this study is to assess the safety and tolerability of ALA and to find the best dose of ALA in patients that receive chemotherapy.


Read more »

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Alpha lipoic acid
The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.

Locations

Country Name City State
United States Northwestern Medical Faculty Foundation Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (13)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation. 4 months Yes
Secondary Proportion of Patients Who Complete the Proposed Regimen of Daily ALA 4 months Yes
Secondary Cumulative Rate of Adverse Events 4 months Yes
Secondary Total Neuropathy Score (TNS) 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. 4 months No
See also
  Status Clinical Trial Phase
Recruiting NCT05152368 - Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy Phase 1
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Completed NCT02549534 - Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer N/A
Active, not recruiting NCT02701075 - MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain N/A
Completed NCT01196442 - Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer N/A
Completed NCT00763087 - Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet N/A
Completed NCT00079807 - Painful HIV Neuropathy and Alpha-Lipoic Acid Phase 1/Phase 2
Completed NCT03292328 - Yoga for Symptoms of Nerve Damage Caused by Chemotherapy N/A
Active, not recruiting NCT05379140 - Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV N/A
Recruiting NCT05673746 - Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer N/A
Completed NCT05189535 - "Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients" Phase 2/Phase 3
Recruiting NCT06219590 - Acetylcholine Iontophoresis As A New Challenge With Type 2 Diabetic Peripheral Neuropathy: A Possible New Therapy N/A
Enrolling by invitation NCT05595109 - Role of Silymarin in Chemotherapy Toxicity and Cognition Improvement in Breast Cancer Patients Phase 2/Phase 3
Completed NCT05916118 - Exercise and Oxaliplatin-induced Peripheral Neuropathy N/A
Withdrawn NCT03881748 - Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy N/A
Not yet recruiting NCT03112057 - Visualize Nociceptor Changes in Neuropathic Human N/A
Completed NCT02936843 - Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy Phase 2/Phase 3
Terminated NCT01458015 - Tapentadol Versus Oxycodon - a Mechanism-based Treatment Approach in Neuropathic Pain Phase 4
Completed NCT01006408 - Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral Neuropathy N/A
Completed NCT00471445 - Topical Amitriptyline and Ketamine Cream in Treating Peripheral Neuropathy Caused by Chemotherapy in Cancer Patients Phase 3