Head and neck cancer patients have a better chance of survival in the 21st century because radiation therapy (RT), either alone or in combination with surgery and/or chemotherapy (CRT) has a high rate of local/regional control, and may extend duration of life. Unfortunately, the elimination of the cancer can leave devastating side effects, including the inability to eat and swallow normally. Organ preservation, often assumed to be the preferred treatment, has now been shown to magnify a dysphagia. Incidence of dysphagia in this group of patients is extremely high, with symptoms continuing to deteriorate for several years after treatment. Conventional therapy for dysphagia yields only minor benefit. Persistence of dysphagia has a major impact on the quality of life of these cancer survivors. Recently, a new therapy approach has been introduced for dysphagia, called e-stim or Neuromuscular Electrical Stimulation (NMES). Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction. An aggressive marketing campaign has turned e-stim into a very popular and sought-after therapy for dysphagia, however, there are no efficacy studies demonstrating its true benefit. We have collected preliminary data with H&N cancer patients using this modality and have seen improved swallow function in 9/15 patients. This is extremely promising and supports the need for a randomized clinical trial. The RCT proposed here will compare NMES therapy combined with traditional exercise therapy to a sham NMES protocol combined with the same exercise therapy, given to post-radiated H&N cancer patients who have moderate to severe dysphagia 3 to 6 months post-XRT, to determine whether NMES is efficacious. Therapy will continue for 12 weeks with an aggressive, daily home program. Objective indicators of a change in swallow function will be taken from fluoroscopy studies. Subjective measures of change will be the patient's self-reported diet, eating ability, and quality of life to indicate whether they perceived a benefit from the therapy. This new treatment may represent the first real hope for improved swallowing in this growing population of cancer survivors. We need to determine whether it represents a truly beneficial treatment or whether our resources should be redirected. If successful, this study will stimulate a multitude of additional research to elucidate the mechanisms underlying this new treatment. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA120950-01A1
Application #
7265529
Study Section
Motor Function, Speech and Rehabilitation Study Section (MFSR)
Program Officer
Timmer, William C
Project Start
2007-07-01
Project End
2012-05-31
Budget Start
2007-07-01
Budget End
2008-05-31
Support Year
1
Fiscal Year
2007
Total Cost
$511,412
Indirect Cost
Name
Boston Medical Center
Department
Type
DUNS #
005492160
City
Boston
State
MA
Country
United States
Zip Code
02118
Meyer, Tanya K; Pisegna, Jessica M; Krisciunas, Gintas P et al. (2017) Residue influences quality of life independently of penetration and aspiration in head and neck cancer survivors. Laryngoscope 127:1615-1621
Krisciunas, Gintas P; Castellano, Kerlly; McCulloch, Timothy M et al. (2017) Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial. Dysphagia 32:327-336
Langmore, Susan E; McCulloch, Timothy M; Krisciunas, Gintas P et al. (2016) Efficacy of electrical stimulation and exercise for dysphagia in patients with head and neck cancer: A randomized clinical trial. Head Neck 38 Suppl 1:E1221-31
Langmore, Susan; Krisciunas, Gintas P; Miloro, Keri Vasquez et al. (2012) Does PEG use cause dysphagia in head and neck cancer patients? Dysphagia 27:251-9
Linkov, Gary; Branski, Ryan C; Amin, Milan et al. (2012) Murine model of neuromuscular electrical stimulation on squamous cell carcinoma: potential implications for dysphagia therapy. Head Neck 34:1428-33
Krisciunas, Gintas P; Sokoloff, William; Stepas, Katherine et al. (2012) Survey of usual practice: dysphagia therapy in head and neck cancer patients. Dysphagia 27:538-49
Kumar, Sandeep; Langmore, Susan; Goddeau Jr, Richard P et al. (2012) Predictors of percutaneous endoscopic gastrostomy tube placement in patients with severe dysphagia from an acute-subacute hemispheric infarction. J Stroke Cerebrovasc Dis 21:114-20
Pearson Jr, William G; Langmore, Susan E; Zumwalt, Ann C (2011) Evaluating the structural properties of suprahyoid muscles and their potential for moving the hyoid. Dysphagia 26:345-51
Colton House, Joyce; Noordzij, J Pieter; Murgia, Bobby et al. (2011) Laryngeal injury from prolonged intubation: a prospective analysis of contributing factors. Laryngoscope 121:596-600
Hey, Christiane; Pluschinski, Petra; Stanschus, Soenke et al. (2011) A documentation system to save time and ensure proper application of the fiberoptic endoscopic evaluation of swallowing (FEESĀ®). Folia Phoniatr Logop 63:201-8

Showing the most recent 10 out of 11 publications