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

NCT02986880 | Completed Phase 2

• 2 other identifiers: 2011/082011-000889-35
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spasm; Radiotherapy Side Effect; Botulinum Toxin

Outcome Measures

Primary Outcomes (1)

• Cervical mobility degree

  6 months

Secondary Outcomes (1)

• Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35)

  6 months

Study Arms (10)

Group D1

EXPERIMENTAL

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.

Drug: Botulinum toxin A

Group D2

EXPERIMENTAL

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.

Drug: Botulinum toxin A

Group D3

EXPERIMENTAL

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.

Drug: Botulinum toxin A

Group A1

EXPERIMENTAL

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.

Drug: Botulinum toxin A

Group A2

EXPERIMENTAL

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.

Drug: Botulinum toxin A

Group A3

EXPERIMENTAL

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.

Drug: Botulinum toxin A

Group F1

EXPERIMENTAL

Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 30 units (U) at injection point, totalling 300 U.

Drug: Botulinum toxin A

Group F2

EXPERIMENTAL

Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 60 units (U) at injection point, totalling 600 U.

Drug: Botulinum toxin A

Group F3

EXPERIMENTAL

Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 100 units (U) at injection point, totalling 1000 U.

Drug: Botulinum toxin A

Group P

PLACEBO COMPARATOR

Patients receiving placebo in the third muscles groups

Procedure: Placebo

Interventions

Botulinum toxin A DRUG

Group A1; Group A2; Group A3; Group D1; Group D2; Group D3; Group F1; Group F2; Group F3

Placebo PROCEDURE

Injection of sodium chloride (NaCl) 9/1000

Group P

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Radiation Injuries

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Christine Bach

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: June 1, 2011
• Primary Completion: January 10, 2014
• Study Completion: January 10, 2014
• Last Updated: May 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)