Peripheral NeuropathyPhase 1NCT02215083
L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
A Phase 1 study testing L-glutamine in people with Peripheral Neuropathy, run by Eastern Regional Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- L-glutamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
About this study
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.
Read the 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.
- Conditions
- Peripheral Neuropathy
- Being tested
- L-glutamine
- Keywords
- peripheral neuropathy, breast cancer, taxane induced peripheral neuropathy, chemotherapy induced peripheral neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-glutamineDietary supplement
Also called Glutamine
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.
| Study group | Role | What they receive |
|---|---|---|
| L-Glutamine | Experimental | All patients will receive 20-30 grams of l-glutamine daily for 9 weeks (+/- 1 week) Receives: Dietary Supplement: L-glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9
Measured: nine weeks
Secondary outcomes (1)
Assess Quality of Life
- 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
Measured: nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Insufficient Patient Population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Regional Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- TSPC America, Inc.
- Responsible party
- Sponsor
- Investigators
- Jack Medendorp, Study director, Eastern Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215083
- Sponsor's protocol ID
- ERMC 13-32
- Status last verified
- Jul 2017
- First submitted
- 11 Aug 2014
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15997923Vahdat 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.
PubMed 11350883
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-glutamine Supplementation to Alleviate Symptoms of Taxane-Induced Neuropathy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT02215083
- Acronym / sponsor ID
- ERMC 13-32
- Conditions
- Peripheral Neuropathy
- Keywords
- peripheral neuropathy, breast cancer, taxane induced peripheral neuropathy, chemotherapy induced peripheral neuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient Patient Population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eastern Regional Medical CenterUniversity, hospital or other
- Collaborators
- TSPC America, Inc.
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-Glutamine | Experimental | Dietary Supplement: L-glutamineAll patients will receive 20-30 grams of l-glutamine daily for 9 weeks (+/- 1 week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-glutamineAlso: Glutamine10,000mg 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. | Dietary supplement | L-Glutamine |
Primary outcome
Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9
Time frame: nine weeks
1 secondary outcome
Assess Quality of Life
Time frame: nine weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Background: PubMed 15997923Stubblefield 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.
- Background: PubMed 11350883Vahdat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Medendorp study director
Eastern Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-glutamine in people with Peripheral Neuropathy, run by Eastern Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sensory neuropathy (area under the curve [AUC]) as measured by the EORTC QLQ-CIPN20 at baseline and week 9 (time frame: nine weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02215083, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.