CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
glutamine +1 moredrug
Likely dose
Glutamine 10 grams orally three times a day for four daysAI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed breast cancer (Stage I-IV) or other solid tumors
  • ✓Currently receiving or recently completed weekly paclitaxel or nab-paclitaxel chemotherapy with at least Grade I peripheral neuropathy from therapy
  • ✓ECOG performance status <1 (Karnofsky >90%)
  • ✓Life expectancy greater than 3 months
Key exclusion· 6
  • ✕Prior neuropathies not associated with chemotherapy
  • ✕Concurrent participation in other investigational drug studies
  • ✕Known brain metastases
  • ✕Uncontrolled intercurrent illness that precludes paclitaxel chemotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00195013
NCT00195013Phase 3Completed
CompareCT.gov

A Randomized Placebo-controlled Trial of Glutamine to Reduce the Signs and Symptoms of Peripheral Neuropathy in Breast Cancer Patients With a Mild Peripheral Neuropathy Receiving Paclitaxel Chemotherapy

Weill Medical College of Cornell University·interventional·Posted Sep 19, 2005·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating glutamine and Placebo for Peripheral Neuropathy and Breast Cancer. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Neuropathy, Breast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartDec 1, 2003
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10.4 yearsPosted 20.8 years ago

Interventions

glutaminedrug

10 grams three times a day (orally) for four days and then stop

Placebodrug

10 grams three times a day (orally) for four days and then stop