NCT00195013

Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. Determine whether oral glutamine supplementation can reduce the symptoms and signs of peripheral neuropathy. 2. Determine whether alterations in the symptoms and signs of peripheral neuropathy are correlated with an alteration of circulating nerve growth factor or insulin-like growth factor levels. 3. Assess whether oral glutamine affects circulating nerve growth factor or insulin-like growth factor levels. 4. Assess whether glutamine interferes with paclitaxel pharmacokinetics

Conditions

• Peripheral Neuropathy
• Breast Cancer

Interventions

Type	Name	Description
DRUG	glutamine	10 grams three times a day (orally) for four days and then stop
DRUG	Placebo	10 grams three times a day (orally) for four days and then stop

Timeline

• Start date: 2003-12-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2005-09-19
• Last updated: 2018-06-06
• Results posted: 2017-08-18

Locations

1 site across 1 country: United States