The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores.
Chemotherapy Induced Peripheral Neuropathy represents a frequent and invalidating side effect that requires treatment. Current treatment options are multiple, but none have yet demonstrated efficacy in double-blind clinical trials . This study will provide information useful to determine the potential of TRO19622 to relieve both pain and dysesthesia which are the most common symptoms experienced by patients with peripheral neuropathy following taxane chemotherapy. At the start of the study, patients will be randomized to one of two groups : TRO19622 (330 mg QD or placebo once a day). Each treatment will be administered for 6 weeks. Additionally, patients will have the option to continue treatment for another 6 weeks duration. Treatment will be administered under double-blind conditions. The product under evaluation will be administered to patients receiving the standard of care for CIPN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
2 capsules of TRO19622 (330 mg) once day with the noon meal
Placebo Control 2 capsules once day with the noon meal
Centre Hospitalier de Versailles Hôpital André Mignot Service d'Hématologie-Oncologie
Le Chesnay, France
Centre Oscar Lambret Département de Sénologie
Lille, France
Centre Léon Bérard Département de Soins de Support
Lyon, France
C.R.L.C Val d'Aurelle Service d'Oncologie Médicale
The primary outcome will be the measure of the percentage of responders defined as patients with a minimum decrease of 50 % of their maximum neuropathic pain dimension (either pain or dysesthesia) present at baseline.
Time frame: The mean pain score during the last 7 days of the treatment period will be compared to the mean score of the last 7 days of the screening score period.
Assessment with respect to placebo of the effect of TRO19622 on Neuropathic Pain Inventory Score(total and by dimension)
Time frame: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on Short- Form BPI
Time frame: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on Quality of life questionnaire (CIPN 20)
Time frame: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on Dysgueusia questionnaire
Time frame: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on Quantitative Sensory Testing
Time frame: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on ENMG
Time frame: V0; V3; V5
Assessment with respect to placebo of the effect of TRO19622 on the use of rescue medication
Time frame: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on safety profile
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Montpellier, France
Centre Alexis Vautrin
Nancy, France
Centre Antoine Lacassagne
Nice, France
Hôpital Nord CHU Saint Etienne Centre de la douleur
Saint-Etienne, France
Hôpital Privé de l'Ouest Parisien Service d'Oncologie
Trappes, France
Time frame: Screening visit; V0; V1; V2; V3; V4 ; V5
Assessment with respect to placebo of the effect of TRO19622 on Global Impression of change as assessed by Investigator
Time frame: V1; V2; V3; V4; V5
Assessment with respect to placebo of the effect of TRO19622 on Global Impression of change as assessed by patient
Time frame: V1; V2; V3; V4; V5
Assessment with respect to placebo of the effect of TRO19622 on Hospital Anxiety and Depression scale
Time frame: V0;V3;V5