Radiation Induced Brachial Plexopathy Clinical Trial
Official title:
Randomized Clinical Trial Evaluating Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy: the PENTOCLO Trial
Radiation-induced brachial plexopathy (RIP) is a rare and severe delayed peripheral nerve
complication of radiotherapy, that is spontaneously irreversible with no medical treatment to
limit or reduce symptoms. The investigators planed in RIP a randomized double blind clinical
trial, using a pentoxifylline (P)- tocopherol (E)- clodronate combination versus placebo, to
assess a possible symptomatic regression by a sensory-motor neurological quantifiable and
reproducible score (modified Subjective Objective Medical management Analytic, SOMA).
The investigators previously developed a successful PE treatment in symptomatic RI injuries
via the antioxidant pathway, in clinical phase II and III trails and experiments obtaining a
major significant radiation-induced fibrosis regression, then the PE clodronate combination
(PENTOCLO), obtaining a rapid and significant healing of mandible osteoradionecrosis and
significant neurological signs regression (- 35% modified SOMA score at 18 months) in 50
partial RIP.
The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its
tolerance in long survival patients irradiated before for cancer and presenting with partial
RIP of upper or lower legs.
The investigators calculated to include 60 patients to show a significant clinical difference
between the two groups after 18 months of treatment: PENTOCLO[Pentoxifylline 400 (2x/d) +
vitamine E 500 (2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple placebo, with
prednisone 20 (2d/7) for all patients.
RIP is assessed before treatment and every 6 months by a standardized sensory-motor
neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and
various neurological scales of assessment (Visual Analog Scale for pain / VAS for
paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS],
muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient
Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and
electrophysiology.
The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its
tolerance in long survival patients irradiated before for cancer and presenting with partial
RIP of upper or lower legs.
We calculated to include 60 patients to show a significant clinical difference between the
two groups after 18 months of treatment: PENTOCLO [Pentoxifylline 400 (2x/d) + vitamine E 500
(2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple placebo, with prednisone 20
(2d/7) for all patients.
RIP is assessed before treatment and every 6 months by a standardized sensory-motor
neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and
various neurological scales of assessment (Visual Analog Scale [VAS] for pain / VAS for
paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS],
muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient
Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and
electrophysiology.
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