Trial of Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy
NCT ID: NCT01291433
Last Updated: 2017-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
59 participants
INTERVENTIONAL
2011-03-31
2017-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PENTOCLO
Association pentoxifylline, tocopherol and clodronate
Pentoxifylline
Pentoxifylline 400 mg: 1 cp twice a day (7d/7)
Tocopherol acetate
Tocopherol alpha-acetate, 500 mg: 1 capsule twice a day (7d/7)
Clodronic Acid
Clodronate disodium (clodronic acid) 800 mg: 2 cp per day, 5d/7 (from monday to friday)
Placebo
Triple placebo
Pentoxifylline placebo
Placebo for pentoxifylline 400 mg, 1 cp twice a day (7d/7)
Tocopherol placebo
Placebo for Tocopherol alpha-acetate, 500 mg: 1 capsule twice a day (7d/7)
Clodronate placebo
Placebo for clodronate disodium (clodronic acid) 800 mg: 2 cp per day, 5d/7 (from monday to friday)
Interventions
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Pentoxifylline placebo
Placebo for pentoxifylline 400 mg, 1 cp twice a day (7d/7)
Pentoxifylline
Pentoxifylline 400 mg: 1 cp twice a day (7d/7)
Tocopherol acetate
Tocopherol alpha-acetate, 500 mg: 1 capsule twice a day (7d/7)
Clodronic Acid
Clodronate disodium (clodronic acid) 800 mg: 2 cp per day, 5d/7 (from monday to friday)
Tocopherol placebo
Placebo for Tocopherol alpha-acetate, 500 mg: 1 capsule twice a day (7d/7)
Clodronate placebo
Placebo for clodronate disodium (clodronic acid) 800 mg: 2 cp per day, 5d/7 (from monday to friday)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* breast cancer with breast or thoracic anterior wall RT; axilla-subclavicular lymph nodes RT; sometimes lung or head/neck cancer
* Lymphoma (Hodgkin or non Hodgkin) with axilla-subclavicular RT (upper limb) or lumbar-aortic (lower limbs) or testis tumor
* Delay RT-RIP more than 6 months, but partial RIP
* Neurological injury in irradiated volume confirmed by EMG
* Patient living within distance compatible with day-hospitalization
* Use of effective contraception for fertile women
* Signed written informed consent (in case of motor paralysis informed consent is signed by a witness)
Exclusion Criteria
* Complete plexus injury with total motor paralysis of upper/ lower limb for more than 2 years
* Associated neurological disease that may interferer with the assessment of endpoints
* Hemorrhage, disease with hemorrhagic risk, unbalanced diabetes
* Known hypersensitivity to Pentoxifylline, one of the excipients or biphosphonates
* Renal failure, liver failure or decompensated heart failure
* Taking another biphosphonate
* Evolving virosis (hepatitis, herpes, zona) or live vaccine (influenza)
* Uncontrolled psychotic condition
* Informed consent not obtained
* Fertile women who do not want or cannot use effective contraception during the administration of study drugs
* Women pregnant or nursing
18 Years
74 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Sylvie Delanian, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oncologie-Radiothérapie, Hôpital Saint Louis , Paris, France
Locations
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Groupe Hospitalier Pitié-Salpêtrière
Paris, , France
Hôpital Saint-Louis
Paris, , France
Countries
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References
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Pradat PF, Maisonobe T, Psimaras D, Lenglet T, Porcher R, Lefaix JL, Delanian S. [Radiation-induced neuropathies: collateral damage of improved cancer prognosis]. Rev Neurol (Paris). 2012 Dec;168(12):939-50. doi: 10.1016/j.neurol.2011.11.013. Epub 2012 Jun 27. French.
Other Identifiers
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P081239
Identifier Type: -
Identifier Source: org_study_id