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

May 24, 2017 updated by: Hopital Foch

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group D1
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.
EXPERIMENTAL: Group D2
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.
EXPERIMENTAL: Group D3
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.
EXPERIMENTAL: Group A1
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.
EXPERIMENTAL: Group A2
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.
EXPERIMENTAL: Group A3
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.
EXPERIMENTAL: Group F1
Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 30 units (U) at injection point, totalling 300 U.
EXPERIMENTAL: Group F2
Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 60 units (U) at injection point, totalling 600 U.
EXPERIMENTAL: Group F3
Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 100 units (U) at injection point, totalling 1000 U.
PLACEBO_COMPARATOR: Group P
Patients receiving placebo in the third muscles groups
Injection of sodium chloride (NaCl) 9/1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cervical mobility degree
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Christine Bach, Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

January 10, 2014

Study Completion (ACTUAL)

January 10, 2014

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (ESTIMATE)

December 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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