Clinical trial NCT02215083: L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
Official title: L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Peripheral Neuropathy
Keywords: peripheral neuropathy
breast cancer
taxane induced peripheral neuropathy
chemotherapy induced peripheral neuropathy
Lead sponsor: Eastern Regional Medical Center
Sponsor class: OTHER
Collaborators: name: TSPC America, Inc.
First posted: 2014-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of the breast
* Received at least one prior taxane-containing chemotherapy regimen which resulted in persistent taxane-induced peripheral neuropathy
* Anticipated survival of at least 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2
* The patient must have screening laboratory: Transaminases\<2.5 x upper limit of normal; total bilirubin \<2.0; creatinine \<1.5
* Neuropathy onset from taxane administration no more than 18 months from date enrolled in trial
* Willingness to adhere to supplemental regimen of l-glutamine 10,000mg taken orally twice daily, with one potential dose escalation to 10,000mg taken orally three times daily.
* Grade I-III sensory peripheral neuropathy related to prior taxane use as assessed by their treating oncologist at Eastern Regional Medical Center
* Able to give informed consent for protocol participation

Exclusion Criteria:

* Participants are not able to understand or provide written informed consent.
* The research team deems that the participant may not be able to follow the study protocol.
* Current diagnosis of bipolar disorder or other manic state
* Prior use of l-glutamine for prevention or empirical treatment of taxane-induced sensory peripheral neuropathy
* Prior treatment with a platinum chemotherapy
* Concurrent use of physical therapy interventions such as the 'Rebuilder', chiropractic care, acupuncture, or other modalities specifically targeting peripheral neuropathy
* Concomitant use of nutraceutical supplements which may mitigate symptoms of taxane-induced peripheral neuropathy including B-Complex vitamins, alpha-lipoic acid, vitamin E, acetyl-l-carnitine, intramuscular B12 injections, fish oil, etc... during study
* Renal insufficiency : serum creatinine of \>1.5 mg /dl
* Hepatic insufficiency: transaminases \> 2.5 x upper limit of normal due to isolated reports of possible hepatic encephalopathy
* New prescription or dose adjustment of current medication for the treatment of peripheral neuropathy such as gabapentin or Lyrica within the past 30 days.
* Pre-existing sensory peripheral neuropathy from other comorbid conditions such as diabetes or alcoholism
* Current serious infection or other serious medical condition
* Currently active second malignancy other than nonmelanatous skin cancer or carcinoma in situ of the cervix
* Pregnant or lactating female (pre-menopausal females will undergo pregnancy test prior to administration of protocol drugs throughout treatment cycles during this study)
* Acetaminophen use exceeding 2 g per day-includes use of acetaminophen-containing pain medications such as Percocet.

Primary outcomes:
measure: Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9
timeFrame: nine weeks
Secondary outcomes:
measure: Assess Quality of Life
timeFrame: nine weeks
Other outcomes:
measure: Observe progression-free survival for 36 months post-intervention with l-glutamine supplementation
timeFrame: 40 months
Locations:
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center
state: Pennsylvania
Study officials:
affiliation: Eastern Regional Medical Center
name: Jack Medendorp
role: STUDY_DIRECTOR
References:
citation: Stubblefield MD, Vahdat LT, Balmaceda CM, Troxel AB, Hesdorffer CS, Gooch CL. Glutamine as a neuroprotective agent in high-dose paclitaxel-induced peripheral neuropathy: a clinical and electrophysiologic study. Clin Oncol (R Coll Radiol). 2005 Jun;17(4):271-6. doi: 10.1016/j.clon.2004.11.014.
citation: Vahdat L, Papadopoulos K, Lange D, Leuin S, Kaufman E, Donovan D, Frederick D, Bagiella E, Tiersten A, Nichols G, Garrett T, Savage D, Antman K, Hesdorffer CS, Balmaceda C. Reduction of paclitaxel-induced peripheral neuropathy with glutamine. Clin Cancer Res. 2001 May;7(5):1192-7.