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Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy. (RILUZOX-01)

Primary Purpose

Oxaliplatin-induced Peripheral Neuropathy

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Riluzole
Placebo Oral Tablet
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxaliplatin-induced Peripheral Neuropathy focused on measuring Riluzole, oxaliplatin, colorectal cancer, neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged ≥ 18 years old,
  2. Eligible patient starting adjuvant oxaliplatin-based chemotherapy (6-12 cycles, Simplified FOLFOX4) for stage II/III colorectal cancer,
  3. Histological or cytological confirmation of colorectal cancer,
  4. Performance status (ECOG) ≤2,
  5. Normal hematological function (ANC ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; hemoglobin ≥9.0 g/dL),
  6. Normal hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome); aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤3 x ULN, and gamma-glutamyltransferase (GGT) ≤3 x ULN,
  7. Normal renal function: serum creatinine ≤1.5 x ULN,
  8. Normal cardiac function: ECG,
  9. Patients affiliated to the French national health insurance,
  10. Patient must have signed a written informed consent form prior to any study specific procedures,
  11. French language comprehension,
  12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

  1. Metastatic cancer,
  2. Diagnosis of neuropathy,
  3. EORTC QLQ-CIPN20 sensory score >6,
  4. Previous neurotoxic chemotherapy treatment,
  5. Patients with chronic obstructive pulmonary disease,
  6. ALAT/ASAT elevated more than 3 times the normal value,
  7. Patients with known allergy or severe hypersensitivity to riluzole or any of the study drug excipients,
  8. Dependence on alcohol or drugs,
  9. Psychotic disorders,
  10. Women pregnant or breastfeeding,
  11. Patients undergoing a measure of legal protection (trusteeship, guardianship ...).

Sites / Locations

  • ICO - Site Paul Papin
  • CH Beauvais
  • Centre François BaclesseRecruiting
  • Hia Percy
  • CHU de Clermont -FerrandRecruiting
  • Clinique St Côme
  • GHPSORecruiting
  • Centre Georges François Leclerc
  • CHU de Dijon
  • CH Annecy-GenevoisRecruiting
  • CHU de Reims
  • Institut Jean Godinot
  • ICO - Site René GauducheauRecruiting
  • Hia BeginRecruiting
  • CHU de Saint-Etienne
  • Hôpital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Riluzole

Placebo

Arm Description

The patient will be taken one tablet twice a day, in the morning and in the evening during the meal (12h interval). The medication is taken during the 14 days of each chemotherapy cycle, beginning 7 days before the start of chemotherapy and ending 2 weeks after the start of last cycle of chemotherapy (25 weeks). The treatment ends with the cessation of chemotherapy (visit V3 or anticipated stop).

Posology, administration and duration of treatment will be equivalent to riluzole group.

Outcomes

Primary Outcome Measures

Quality of life questionnaire-chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
QLQ-CIPN20 Questionnaire (EORTC): Self-reported questionnaire consisting of 20 questions that assess the symptoms and functional limitations of chemotherapy-induced peripheral neuropathy. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of chemotherapy-induced peripheral neuropathy (CIPN). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), patients indicate the degree to which they have experienced sensory, motor, and autonomic symptoms.

Secondary Outcome Measures

QLQ-CIPN20
Self-reported questionnaire consisting of 20 questions that assess the symptoms and functional limitations of chemotherapy-induced peripheral neuropathy. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of CIPN. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), patients indicate the degree to which they have experienced sensory, motor, and autonomic symptoms.
National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
The NCI-CTCAE v5.0 is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.
Brief Pain Inventory (BPI) questionnaire
This self-report questionnaire includes: A body schema The maximum pain, lowest pain, usual pain within the last 15 days (Numerical Numeric rating scales (NRS) 0 to 10 Description of current analgesic treatment, An assessment of relief by a percentage scale (0-100%), Assessment of the impact of pain on: mood, relationships with others, walking, sleep, work, happiness the joy - of living, recreation, activities in general (digital scales, rating from 0 [normal] to 10 [no activity]).
Douleur Neuropathique 4 (DN4) questionnaire (interview portion)
The interview portion of the DN4 questionnaire is a clinician-administered screening tool for neuropathic pain. The questionnaire includes 7 items, grouped into two questions. Each item, is answered as either YES or NO. A final cumulative patient's score is obtained by allocating 1 point for each YES and 0 point for each NO. If the patient's score is ≥3/7, the test is positive.
Neuropathic Pain Symptom Inventory (NPSI) questionnaire
This self-reported questionnaire assesses different neuropathic pain symptoms. The French NPSI includes 12 items that discriminates and quantifies five distinct dimensions of neuropathic pain. Each of these items are quantified on a (0-10) numerical scale.
QLQ-C30 questionnaire (EORTC)
This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Disease progression
Disease Free Survival, defined as the interval between the date of randomization and the date of cancer relapse (local, regional, metastases, second cancer) or death from any cause, whichever occurs first.
Time to HRQoL score deterioration
The interval between randomization and deterioration ≥5 points in the HRQoL score as compared to baseline score or death (all causes).
Quantification of chemotherapy dose reductions
The number of chemotherapy dose reduction caused by severe neuropathy and/or poor tolerance of treatment will be recorded.
Quantification of cumulative dose
The cumulative dose (mg/m²) of chemotherapy delivered to patients will be recorded.
Evaluation of study exit rates
The study exit rate caused by severe neuropathy and/or poor tolerance of treatment will be recorded.
Assessment of glutamate serum level
Correlation with colorectal cancer tumors/nodes/metastases (TNM) score (and eventually neuropathic symptoms), glutamate plasmatic

Full Information

First Posted
October 11, 2018
Last Updated
February 14, 2023
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT03722680
Brief Title
Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.
Acronym
RILUZOX-01
Official Title
Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is a phase II trial, randomized, parallel, double blind, multicenter, comparing riluzole versus placebo. The trial population is composed of patients ≥18 years old that have developed stage II/III colorectal cancer and are eligible for Simplified FOLFOX4 (6-12 cycles) adjuvant chemotherapy. The primary objective is to assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy during the Simplified FOLFOX4 adjuvant chemotherapy of stage II/III colorectal cancers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxaliplatin-induced Peripheral Neuropathy
Keywords
Riluzole, oxaliplatin, colorectal cancer, neuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Riluzole arm: The patient will be taken one tablet (riluzole 50 mg, film-coated tablet) twice a day, in the morning and in the evening during the meal (12h interval). The medication is taken during the 14 days of each chemotherapy cycle, beginning 7 days before the start of chemotherapy and ending 2 weeks after the start of last cycle of chemotherapy (25 weeks). The treatment ends with the cessation of chemotherapy (visit V3 or anticipated stop).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo arm: The patient will be taken on tablet (placebo :50 mg, film-coated tablet) Posology, administration and duration of treatment will be equivalent to riluzole group.
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Riluzole
Arm Type
Experimental
Arm Description
The patient will be taken one tablet twice a day, in the morning and in the evening during the meal (12h interval). The medication is taken during the 14 days of each chemotherapy cycle, beginning 7 days before the start of chemotherapy and ending 2 weeks after the start of last cycle of chemotherapy (25 weeks). The treatment ends with the cessation of chemotherapy (visit V3 or anticipated stop).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Posology, administration and duration of treatment will be equivalent to riluzole group.
Intervention Type
Drug
Intervention Name(s)
Riluzole
Intervention Description
Riluzole during chemotherapy (oxaliplatin)
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Quality of life questionnaire-chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
Description
QLQ-CIPN20 Questionnaire (EORTC): Self-reported questionnaire consisting of 20 questions that assess the symptoms and functional limitations of chemotherapy-induced peripheral neuropathy. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of chemotherapy-induced peripheral neuropathy (CIPN). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), patients indicate the degree to which they have experienced sensory, motor, and autonomic symptoms.
Time Frame
3 months afer initiation of oxaliplatin based chemotherapy (1 cycle = 14 days)
Secondary Outcome Measure Information:
Title
QLQ-CIPN20
Description
Self-reported questionnaire consisting of 20 questions that assess the symptoms and functional limitations of chemotherapy-induced peripheral neuropathy. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of CIPN. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), patients indicate the degree to which they have experienced sensory, motor, and autonomic symptoms.
Time Frame
At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Title
National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Description
The NCI-CTCAE v5.0 is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.
Time Frame
throughout study completion, assessed up to 43 months
Title
Brief Pain Inventory (BPI) questionnaire
Description
This self-report questionnaire includes: A body schema The maximum pain, lowest pain, usual pain within the last 15 days (Numerical Numeric rating scales (NRS) 0 to 10 Description of current analgesic treatment, An assessment of relief by a percentage scale (0-100%), Assessment of the impact of pain on: mood, relationships with others, walking, sleep, work, happiness the joy - of living, recreation, activities in general (digital scales, rating from 0 [normal] to 10 [no activity]).
Time Frame
At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Title
Douleur Neuropathique 4 (DN4) questionnaire (interview portion)
Description
The interview portion of the DN4 questionnaire is a clinician-administered screening tool for neuropathic pain. The questionnaire includes 7 items, grouped into two questions. Each item, is answered as either YES or NO. A final cumulative patient's score is obtained by allocating 1 point for each YES and 0 point for each NO. If the patient's score is ≥3/7, the test is positive.
Time Frame
This evaluation will be carried out only if the item 5 of BPI "general pain felt in the last 7 days" is ≥4/10.
Title
Neuropathic Pain Symptom Inventory (NPSI) questionnaire
Description
This self-reported questionnaire assesses different neuropathic pain symptoms. The French NPSI includes 12 items that discriminates and quantifies five distinct dimensions of neuropathic pain. Each of these items are quantified on a (0-10) numerical scale.
Time Frame
This evaluation will be carried out only if the item 5 of BPI "general pain felt in the last 7 days" is ≥4/10.
Title
QLQ-C30 questionnaire (EORTC)
Description
This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Time Frame
At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Title
Disease progression
Description
Disease Free Survival, defined as the interval between the date of randomization and the date of cancer relapse (local, regional, metastases, second cancer) or death from any cause, whichever occurs first.
Time Frame
From date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 43 months.
Title
Time to HRQoL score deterioration
Description
The interval between randomization and deterioration ≥5 points in the HRQoL score as compared to baseline score or death (all causes).
Time Frame
At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Title
Quantification of chemotherapy dose reductions
Description
The number of chemotherapy dose reduction caused by severe neuropathy and/or poor tolerance of treatment will be recorded.
Time Frame
3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.
Title
Quantification of cumulative dose
Description
The cumulative dose (mg/m²) of chemotherapy delivered to patients will be recorded.
Time Frame
3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.
Title
Evaluation of study exit rates
Description
The study exit rate caused by severe neuropathy and/or poor tolerance of treatment will be recorded.
Time Frame
3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.
Title
Assessment of glutamate serum level
Description
Correlation with colorectal cancer tumors/nodes/metastases (TNM) score (and eventually neuropathic symptoms), glutamate plasmatic
Time Frame
Glutamate serum level will be dose at inclusion (V0), 3 months (V2), up to 7 months (V3), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged ≥ 18 years old, Eligible patient starting adjuvant oxaliplatin-based chemotherapy (6-12 cycles, Simplified FOLFOX4) for stage II/III colorectal cancer, Histological or cytological confirmation of colorectal cancer, Performance status (ECOG) ≤2, Normal hematological function (ANC ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; hemoglobin ≥9.0 g/dL), Normal hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome); aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤3 x ULN, and gamma-glutamyltransferase (GGT) ≤3 x ULN, Normal renal function: serum creatinine ≤1.5 x ULN, Normal cardiac function: ECG, Patients affiliated to the French national health insurance, Patient must have signed a written informed consent form prior to any study specific procedures, French language comprehension, Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Exclusion Criteria: Metastatic cancer, Diagnosis of neuropathy, EORTC QLQ-CIPN20 sensory score >6, Previous neurotoxic chemotherapy treatment, Patients with chronic obstructive pulmonary disease, ALAT/ASAT elevated more than 3 times the normal value, Patients with known allergy or severe hypersensitivity to riluzole or any of the study drug excipients, Dependence on alcohol or drugs, Psychotic disorders, Women pregnant or breastfeeding, Patients undergoing a measure of legal protection (trusteeship, guardianship ...).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis PEZET, MD-PHD
Phone
+ 33 ( 0) 4 73 75 04 94
Email
dpezet@chu-clermontferrand.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Helene RIBAULT
Email
h-ribault@unicancer.fr
Facility Information:
Facility Name
ICO - Site Paul Papin
City
Angers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia QUINTIN, MD
Phone
02 41 35 27 00
Email
Julia.Quintin@ico.unicancer.fr
Facility Name
CH Beauvais
City
Beauvais
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayçal HOCINE, MD
Phone
03 44 11 23 09
Email
f.hocine@ch-beauvais.fr
Facility Name
Centre François Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélie Parzy, MD
Phone
02 31 45 50 16
Email
a.parzy@baclesse.unicancer.fr
Facility Name
Hia Percy
City
Clamart
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien RICARD, MD
Phone
01 41 46 68 85
Email
damien1.ricard@intradef.gouv.fr
Facility Name
CHU de Clermont -Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Pezet, MD
Phone
04 73 75 04 94
Email
dpezet@chu-clermontferrand.fr
Facility Name
Clinique St Côme
City
Compiègne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazïs ALDDABAGH, MD
Phone
03 44 92 43 53
Email
kais.alddabagh@stcome.com
Facility Name
GHPSO
City
Creil
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth CAROLA, MD
Email
Elisabeth.Carola@ghpso.fr
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François GHIRINGHELLI, MD
Phone
03 80 73 77 52
Email
FGhiringhelli@cgfl.fr
Facility Name
CHU de Dijon
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain MANFREDI, MD
Phone
03 80 29 37 50
Email
sylvain.manfredi@chu-dijon.fr
Facility Name
CH Annecy-Genevois
City
Pringy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude MONTCHAUD, MD
Phone
04 50 63 66 05
Email
amontchaud@ch-annecygenevois.fr
Facility Name
CHU de Reims
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier BOUCHE, MD
Phone
03.26.78.71.72
Email
obouche@chu-reims.fr
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien BOTSEN, MD
Email
damien.botsen@reims.unicancer.fr
Facility Name
ICO - Site René Gauducheau
City
Saint-Herblain
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia QUINTIN, MD
Phone
02 40 67 99 33
Email
Julia.Quintin@ico.unicancer.fr
Facility Name
Hia Begin
City
Saint-Mandé
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François-Régis FERRRAND, MD
Phone
01 43 98 52 43
Email
francoisregisferrand@gmail.com
Facility Name
CHU de Saint-Etienne
City
Saint-Priest
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc PHELIP, MD
Email
j.marc.phelip@chu-st-etienne.fr
Facility Name
Hôpital Foch
City
Suresnes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmahane BENMAZIANE TEILLET, MD
Phone
+33 (0)1 46 25 24 10
Email
a.benmaziane@hopital-foch.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Citations:
PubMed Identifier
31182448
Citation
Kerckhove N, Busserolles J, Stanbury T, Pereira B, Plence V, Bonnetain F, Krakowski I, Eschalier A, Pezet D, Balayssac D. Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: RILUZOX-01: protocol of a randomised, parallel, controlled, double-blind and multicentre study by the UNICANCER-AFSOS Supportive Care intergroup. BMJ Open. 2019 Jun 9;9(6):e027770. doi: 10.1136/bmjopen-2018-027770.
Results Reference
derived

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Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.

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