Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

Radiotherapy Side Effect Clinical Trial

Official title:

A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986880
• Other study ID #: 2011/08
• Secondary ID: 2011-000889-35
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2016
• Last updated: May 24, 2017
• Start date: June 2011
• Est. completion date: January 10, 2014

Study information

• Verified date: May 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 10, 2014
• Est. primary completion date: January 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Botulinum Toxin
• Cervical Spasm
• Contracture
• Radiotherapy Side Effect
• Torticollis

Intervention

Drug:
• Botulinum toxin A

Procedure:
• Placebo
Injection of sodium chloride (NaCl) 9/1000

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical mobility degree		6 months
Secondary	Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35)		6 months