Efficacy Study of Botulinum Toxin (BOTOX) Injections to Treat Vocal Fold Granulomas

NCT01678053 | Withdrawn Phase 2 DMC

• 1 other identifier: 11-090H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Vocal process granulomas are inflammatory masses caused in part by vocal trauma that arise in the posterior aspect of the vocal folds and result in throat pain, difficulty swallowing, hoarseness, and globus sensation. Antireflux therapy treats most granulomas, but many are recalcitrant to this therapy or take months to years to resolve. Botulinum toxin injection into the thyroarytenoid muscle has been effectively employed for recalcitrant granuloma, but causes significant voice loss, occasional difficulty swallowing and, in our clinical experience, is associated with significant recurrence. The investigators propose injecting another muscle in the larynx called the interarytenoid muscle with botulinum toxin type A to maintain the benefit of injection with less loss of voice. The investigators have shown the effectiveness of this treatment in a small, retrospective analysis.

Conditions

Contact Ulcer of Vocal Folds; Granuloma of Vocal Cords; Granuloma, Laryngeal; Granuloma

Keywords

Botulinum Toxins, Type A

Outcome Measures

Primary Outcomes (1)

• Complete resolution of vocal fold granuloma

  3 months

Secondary Outcomes (1)

• Voice Handicap Index score

  3 months

Study Arms (2)

PPI and BOTOX

EXPERIMENTAL

onabotulinumtoxinA (BOTOX), injection, 10 units, one time; omeprazole 40mg po bid (standard of care) for 3 months

Drug: onabotulinumtoxinA; Drug: omeprazole (proton pump inhibitor)

Proton pump inhibitor only

OTHER

omeprazole 40mg po bid for 3 months(standard of care)

Drug: omeprazole (proton pump inhibitor)

Interventions

onabotulinumtoxinA DRUG

Botulinum toxin A is injected into the larynx in order to treat vocal fold granulomas.

Also known as: BOTOX, Botulinum toxin A

PPI and BOTOX

omeprazole (proton pump inhibitor) DRUG

Standard therapy of anti-reflux medications using omeprazole or equivalent PPI.

Also known as: omeprazole

PPI and BOTOX; Proton pump inhibitor only

Eligibility Criteria

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

You may qualify if:

• adults age 18 years old and older with vocal fold granulomas
• willing to attend all follow-up appointments

You may not qualify if:

• pregnant females
• woman who are nursing
• minors and other patients unable to give informed consent
• patients taking Plavix
• patients with:
• impaired laryngeal motion as the result of neurological impairment
• vocal fold immobility
• pre-existing oropharyngeal swallowing problems
• history of radiation therapy
• history of aspiration pneumonia

Sponsors & Collaborators

• Phillip Song, MD: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• de Lima Pontes PA, De Biase NG, Gadelha EC. Clinical evolution of laryngeal granulomas: treatment and prognosis. Laryngoscope. 1999 Feb;109(2 Pt 1):289-94. doi: 10.1097/00005537-199902000-00021.

  PMID: 10890781 BACKGROUND

• Emami AJ, Morrison M, Rammage L, Bosch D. Treatment of laryngeal contact ulcers and granulomas: a 12-year retrospective analysis. J Voice. 1999 Dec;13(4):612-7. doi: 10.1016/s0892-1997(99)80015-0.

  PMID: 10622526 BACKGROUND

• Pham J, Yin S, Morgan M, Stucker F, Nathan CO. Botulinum toxin: helpful adjunct to early resolution of laryngeal granulomas. J Laryngol Otol. 2004 Oct;118(10):781-5. doi: 10.1258/0022215042450788.

  PMID: 15550184 BACKGROUND

• Nasri S, Sercarz JA, McAlpin T, Berke GS. Treatment of vocal fold granuloma using botulinum toxin type A. Laryngoscope. 1995 Jun;105(6):585-8. doi: 10.1288/00005537-199506000-00005.

  PMID: 7769940 BACKGROUND

• Damrose EJ, Damrose JF. Botulinum toxin as adjunctive therapy in refractory laryngeal granuloma. J Laryngol Otol. 2008 Aug;122(8):824-8. doi: 10.1017/S0022215107000710. Epub 2007 Oct 2.

  PMID: 17908354 BACKGROUND

• Ylitalo R, Lindestad PA. A retrospective study of contact granuloma. Laryngoscope. 1999 Mar;109(3):433-6. doi: 10.1097/00005537-199903000-00017.

  PMID: 10089971 BACKGROUND

MeSH Terms

Conditions

Granuloma, Laryngeal; Granuloma

Interventions

Botulinum Toxins, Type A; Omeprazole; Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Granuloma, Respiratory Tract; Respiratory Tract Diseases; Laryngeal Diseases; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases

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; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Phillip Song, M.D.

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Otolaryngologist

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

US (1)