Randomized Clinical Trial Evaluating Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy: the PENTOCLO Trial
18 Years
74 Years
Both
Radiation Induced Brachial Plexopathy
Trial Information
Randomized Clinical Trial Evaluating Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy: the PENTOCLO Trial
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.
Inclusion Criteria:
- Past-history of post-operative or exclusive irradiation (RT) for currently in
remission cancer, in particular
- 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:
- Localized or metastatic cancer recurrence (axillar MRI or PET scan)
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Sensory-motor neurological clinical assessment
Outcome Description:
Sensory-motor neurological clinical assessment of RIP patients as measured with SOMA scale (Subjective Objective Medical management Analytic involving tools) modified by NCI-CTC99 scale
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Sylvie Delanian, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Oncologie-Radiothérapie, Hôpital Saint Louis , Paris, France
Authority:
France: Ministry of Health
Study ID:
P081239
NCT ID:
NCT01291433
Start Date:
March 2011
Completion Date:
September 2015
Related Keywords:
- Radiation Induced Brachial Plexopathy
- Brachial Plexus Neuropathies
- Radiation Injuries
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