Botox Found to Help Patients Speak

Release: July 29, 2000

Contact: Kenneth Satterfield
703-519-1563
[email protected]

In San Francisco (7/28-8/2)
415-284-8082

BOTOX FOUND TO HELP PATIENTS SPEAK SUCCESSFULLY AFTER LARYNGECTOMY

Objective data regarding the use of Botulinum toxin to control muscle spasms that preclude effective tracheoesopheal speech production following total laryngectomy

San Francisco, CA -- A new study from the M.D. Anderson Cancer Center in Houston, Texas provides objective data that Botulinum toxin (Botox) injection offers a simpler and effective method of treatment for a select group of cancer patients who are unable to speak following total laryngectomy and tracheoesophageal (TE) puncture. It allows people the potential to achieve an improved quality of life at work, in social and family interactions, by re-establishing verbal communication similar to their presurgical ability to speak with a larynx.

The authors of the study, "Further Experience with Botox Injection for Tracheoesophageal Speech Failure," are Jan S. Lewin, PhD, Julie K. Bishop-Leone, CCC-SLP, Arthur D. Forman MD, and Eduardo M. Diaz, Jr. MD, all from the Department of Head and Neck Surgery, and Arthur D. Forman, MD from the Department of Neuro-Oncololgy at The University of Texas M. D. Anderson Cancer Center, in Houston, Texas. The findings will be presented before the 5th International Conference on Head and Neck Cancer, being held July 29 through August 2, at the San Francisco Marriott, San Francisco, CA. More than 1,500 leading head and neck surgeons from the United States and 46 nations will gather to hear the latest medical research regarding the diagnosis, treatment, and reconstruction associated with of patients with head and neck cancer. The medical conference is sponsored by the American Head and Neck Society, www.headandneckcancer.org.

Background: Botox injection is routinely used to relieve a variety of dystonias and muscle spasms such as those that affect the neck (torticollis) and hands,(writer's cramp) as well as areas of hypertonicity in the head and neck. Plastic surgeons use it routinely to relieve eye muscle spasms and eliminate wrinkles. Botox injection causes a temporary paralysis of the involved musculature usually requiring re-injection to maintain the desired effect. the treatment is not permanent and must be re-injected.

Total laryngectomy results in a loss of the ability to communicate orally that dramatically affects quality of life. Following laryngectomy, patients may choose to speak using tracheoesophageal (TE) voice production which is an alaryngeal speech alternative that offers the laryngectomized individual the potential for spontaneous, effortless speech production very much like that of normal laryngeal speech in terms of quality, fluency, and ease of production. TE speech is produced using a unidirectional valved prosthesis that protects the airway during swallowing and diverts pulmonary air into the esophagus for phonation when the tracheostoma is occluded. It does not require the use of mechanical instruments, and is associated with a rapid rehabilitative process , (approximately 3 to 5 sessions) The most common reason for TE speech failure is a spasm that prevents the superior flow of air for sound production and thus oral communication. Although several methods have been used in the past to treat the problem, most frequently surgical, results have not always been successful. The researchers in this study set out to determine overall TE speech outcomes following Botox injection and establish more objective information regarding the duration of the effect and the general rate of reinjection necessary to maintain TE speech production following successful injection.
Methodology: Twenty-three patients who failed to achieve a conversational level of TE speech production following TE puncture were included in this study. Nineteen males and four females between the ages of 37 and 83 years served as subjects. Ten of the 23 patients (44 percent) underwent primary TE puncture at the time of laryngectomy and 13 (56 percent) had TE puncture performed secondarily. Nineteen of 23 patients (83 percent) had received radiation therapy. Patients with a diagnosis of hypopharyngeal stricture were excluded from participation in the study. The mean follow-up was 616 days (range: 22 to 1,114 days). The surgeon's operative report indicated myotomy in 14 of 23 patients (61 percent). Myotomy was not reported in nine of the 23 patients (39 percent). Despite attempts to improve speech fluency, speech therapy did not improve speech production in any of the subjects prior to Botox injection.

Each patient was evaluated using objective intraesophageal insufflation. Fluent speech was defined as an ability to produce 10 to 15 syllables per breath and sustain a vowel production (/a/) for a minimum of 10 seconds at intra esophageal pressure levels less than or equal to 20 mm Hg on a pressure manometer. Patients who failed to meet the criteria for either or both tasks underwent video fluoroscopic recording to further evaluate and mark the area of muscle spasm for subsequent Botox injection. The patient swallowed a minimal amount of barium sulfate to coat the esophagus for adequate visualization. The area of hypertonicity was identified while the patient attempted to phonate and then marked with radio-opaque nipple markers and an indelible pen.

The patient underwent subsequent Botox injection within 24 hours of testing. Patients returned three to four weeks following injection for re-evaluation to objectively confirm absence of muscle spasm via intra esophageal insufflation. A second injection was offered to patients who failed to achieve fluent TE speech production after the first Botox injection. Two patients received a third Botox injection following partial success after the second one. Re-injection was scheduled and completed six to eight weeks following the previous injection. Injection dosages and titration remained the same throughout the study. A re-evaluation of voice outcome was completed three to four weeks later to assess the patient's response.

Usually two to three injections were performed side along the neopharynx between previously placed markers. Local anesthesia was not used because the injection is well tolerated and the swelling caused by injection of the anesthetic may alter anatomic landmarks. While it usually takes 24 to 48 hours to achieve a noticeable difference, some patients achieve some improvement in symptoms during clinic visits. To date, no complications or morbidity were experienced with this technique, nor have there been any allergic reactions.

Results: Overall, 20 of 23 patients (87 percent) were successful in achieving TE speech production following Botox injection. Two patients (nine percent) refused a second injection after failure to achieve TE speech criteria following the first injection. Only one patient (four percent) ultimately failed to achieve TE speech success following three Botox injections.

Eight of the 23 patients (35 percent) failed to achieve TE speech production following their initial Botox injection. Six of the eight (75 percent) underwent a second injection and two (25 percent) refused further intervention. Four of the six patients (67 percent) who had a second Botox injection were successful, two (33 percent) were not. The longest sustained effect was 37 months. The shortest sustained effect was five months for one patient (four percent) who demonstrated vocal deterioration and needed re-injection of Botox to maintain TE speech production.

Conclusions: The results of this study support and expand the findings of other investigators by providing objective data and a standard protocol that demonstrate Botox injection is a simple, safe and effective alternative for the relief of pharyngeal constrictor hypertonicity in a majority of patients who fail to achieve TE speech production following total laryngectomy. Further studies will be necessary to investigate the mechanism for the long-lasting effect of Botox injection on pharyngeal constrictor spasm in this population. However, our study has conclusively demonstrated the long-lasting success of Botox injection to provide successful TE speech production and thus the potential to greatly improve the quality of life for many patients following total laryngectomy.

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