Completed

PENTOCLORandomized Clinical Trial Evaluating Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy: the PENTOCLO Trial

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What is being tested

Pentoxifylline placebo

+ Tocopherol placebo

+ Clodronate placebo

Drug
Who is being recruted

From 18 to 74 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: March 2011
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2011

Actual date on which the first participant was enrolled.

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.

Official TitleRandomized Clinical Trial Evaluating Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy: the PENTOCLO Trial
NCT01291433
Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

59 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 74 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Triple placebo

Group II

Experimental
Association pentoxifylline, tocopherol and clodronate

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Groupe Hospitalier Pitié-Salpêtrière

Paris, FranceOpen Groupe Hospitalier Pitié-Salpêtrière in Google Maps
Suspended

Hôpital Saint-Louis

Paris, France
Completed2 Study Centers