Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Breast Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Taxane

Glutamine

All patients will receive 20-30 grams of l-glutamine daily for 9 weeks (+/- 1 week)

10,000mg by mouth, twice daily for nine weeks (± 7 days) with one permitted dose escalation to a maximum of 10,000mg by mouth three times daily.

L-glutamine

Jack Medendorp

The purpose of the study is to determine whether daily, high-dose administration of l-glutamine can reduce numbness and tingling caused by a taxane chemotherapy in patients with breast cancer.

L-glutamine has previously been shown to help reduce the incidence of numbness and tingling in patients with breast cancer who are receiving taxane chemotherapies. However, no study to date looks at the effect of l-glutamine given after this numbness and tingling (called 'perihperhal neuropathy') has already occurred. We hypothesize that administration of this amino acid in l-glutamine naïve patients will result in a measureable reduction of their taxane-induced neuropathy.

L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer

Quarterly record review to determine progression-free survival for 36 months post-l-glutamine intervention

* Motor neuropathy as measured by the EORTC QLQ-CIPN20 at baseline and week 9
* Autonomic symptoms and functioning as measured by the EORTC QLQ-CIPN20 at baseline and week 9
* Overall quality of life as measured by the EORTC-30 questionnaire at baseline, 3 weeks, 6 weeks, and week 9
* Pain severity as measured by the Visual Analog Numeric Pain Scale at baseline, week 3, week 6 and week 9
* Objective assessment performed by Physical Therapy Department as measured by the Functional Gait Assessment at baseline and week 9
* 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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer	NCT02215083	Peripheral Neur...	L-glutamine	18 Years -	Eastern Regional Medical Center
L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer	NCT02215083	Peripheral Neur...	L-glutamine	18 Years -	Eastern Regional Medical Center

Spots Global Cancer Trial Database for taxane induced peripheral neuropathy