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

Primary Purpose

Cervical Spasm, Radiotherapy Side Effect, Botulinum Toxin

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Botulinum toxin A
Placebo
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spasm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group D1

Group D2

Group D3

Group A1

Group A2

Group A3

Group F1

Group F2

Group F3

Group P

Arm Description

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.

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.

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.

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.

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.

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.

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

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

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

Patients receiving placebo in the third muscles groups

Outcomes

Primary Outcome Measures

Cervical mobility degree

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2016
Last Updated
May 24, 2017
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02986880
Brief Title
Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures
Official Title
A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 10, 2014 (Actual)
Study Completion Date
January 10, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spasm, Radiotherapy Side Effect, Botulinum Toxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group D1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group D2
Arm Type
Experimental
Arm Description
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.
Arm Title
Group D3
Arm Type
Experimental
Arm Description
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.
Arm Title
Group A1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group A2
Arm Type
Experimental
Arm Description
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.
Arm Title
Group A3
Arm Type
Experimental
Arm Description
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.
Arm Title
Group F1
Arm Type
Experimental
Arm Description
Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 30 units (U) at injection point, totalling 300 U.
Arm Title
Group F2
Arm Type
Experimental
Arm Description
Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 60 units (U) at injection point, totalling 600 U.
Arm Title
Group F3
Arm Type
Experimental
Arm Description
Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 100 units (U) at injection point, totalling 1000 U.
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
Patients receiving placebo in the third muscles groups
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Injection of sodium chloride (NaCl) 9/1000
Primary Outcome Measure Information:
Title
Cervical mobility degree
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Bach
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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