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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000889-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cervical mobility degree | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Bach | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | 92150 | France |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Group P | Placebo Comparator | Patients receiving placebo in the third muscles groups |
|
| Placebo | Procedure | Injection of sodium chloride (NaCl) 9/1000 |
|
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |