Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures
Phase 2
Completed
- Conditions
- Cervical SpasmRadiotherapy Side EffectBotulinum Toxin
- Interventions
- Procedure: Placebo
- Registration Number
- NCT02986880
- Lead Sponsor
- Hopital Foch
- Brief Summary
The main objective of the study is to estimate the efficiency and to determine the optimal dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections.
The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the splenius capitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Patients from 18 to 75 years old;
- malignant Tumor of aerodigestive ways, in forgiveness;
- Treatment containing the external radiotherapy ended since > 6 months
- Life expectancy > 6 months;
- patient complaining from cervical spasms with functional disability;
- Negative Pregnancy test;
- Women under effective contraception;
- Patients benefiting from a national insurance scheme;
- Patient having given a written consent.
Exclusion Criteria
- Cervico-facial Surgery with reconstruction by pedicled flap
- Implantable Chamber with catheter in the internal jugular vein near the spasm;
- Muscular, neurological Pathology or malformative pulling a disorder of perception of the pain, an amyotrophy, a muscular weakness affecting the cervical axis or the upper limbs;
- Disorder generalized by the muscular activity (ex myasthenia);
- Cervical osseous or muscular Pathology pulling pains and disability before the beginning of the treatment (cervical degenerative osteoarthritis diagnosed to the cervical radiography, the slipped disc);
- Previous cervical injection of botulinum toxin ;
- Local Infection at the level of one of the sites proposed for injection;
- Histories of epilepsy;
- Patients presenting a hypersensitivity to the botulinum neurotoxin A or in one of its excipients;
- Patients under anticoagulation therapy, Under antibiotic treatment by aminoglycosides or amino 4 quinoline, under myorelaxant treatment or that must undergo an intervention with curarisation;
- Patients for whom a surgical operation is planned in the zone interested in the treatment
- Pregnant or breast-feeding Women;
- Patients for whom questionnaires will not be assessable (handicaps of communication, patient not speaking French, etc.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group P Placebo Patients receiving placebo in the third muscles groups Group F2 Botulinum toxin A Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 60 units (U) at injection point, totalling 600 U. Group D1 Botulinum toxin A Patients receiving the toxin in SCM and the placebo in trapezius muscle and splenius capitis. Patients receiving the dose of 30 units (U) at injection point, totalling 120 U. Group D2 Botulinum toxin A Patients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 60 units (U) at injection point, totalling 240 U. Group D3 Botulinum toxin A Patients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 100 units (U) at injection point, totalling 400 U. Group A1 Botulinum toxin A Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 30 units (U) at injection point, totalling 180 U. Group A2 Botulinum toxin A Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 60 units (U) at injection point, totalling 360 U. Group A3 Botulinum toxin A Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 100 units (U) at injection point, totalling 600 U. Group F1 Botulinum toxin A Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 30 units (U) at injection point, totalling 300 U. Group F3 Botulinum toxin A Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 100 units (U) at injection point, totalling 1000 U.
- Primary Outcome Measures
Name Time Method Cervical mobility degree 6 months
- Secondary Outcome Measures
Name Time Method Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35) 6 months
Trial Locations
- Locations (1)
Hopital Foch
🇫🇷Suresnes, France