Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients

Overview

About this study

The purpose of the investigation is to learn whether intense swallowing exercise or intense swallowing exercise coupled with electrical stimulation (E-Stim) helps patients who had head/neck cancer and currently have dysphagia swallow better.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female ages 21+
  • At least 3 months post-radiation therapy for head & neck cancer
  • Treatment for their cancer can include chemotherapy.
  • Surgery for their cancer, if done, must meet these criteria:

    • diagnostic biopsy
    • less than ½ of oral tongue resected
    • less than ½ of tongue base resected
    • no floor of mouth muscles resected
    • less than 50% of any other part of the oral cavity, pharynx or larynx resected
    • no resection of hyoid
    • Neck dissection, unilateral or bilateral neck dissections may have been completed prior to or after radiation therapy.
  • Currently free of cancer, confirmed by head and neck exam within 2 months of beginning the study
  • MBS demonstrates penetration or aspiration on at least one swallow during the study (minimum PAS = 4)
  • The patient is free of any medical conditions that could limit the patient's ability to follow the protocol.
  • No history of any swallowing problems prior to the onset of head and neck cancer
  • Prior swallow therapy, if given to the patient, is neither an Inclusion nor Exclusion criteria

Exclusion Criteria:

  • Inability to cooperate with the examination and treatment.
  • An implanted electrical device (e.g., pacemaker, deep brain stimulator, defibrillator, vagal nerve stimulator)
  • Previous e-stim treatment to the head & neck
  • Any current or previous neurological disease which may adversely affect swallowing.
  • History of oropharyngeal swallowing disorder prior to cancer.
  • History of pre-cancer oral intake that was limited due to a swallowing problem.
  • Previous neurosurgery on the brain that could compromise swallowing or ability to follow protocol.
  • Severe COPD (oxygen dependent).
  • Need for dilation of the upper esophageal sphincter or esophagus at time of entry.
  • Females who are currently pregnant will be excluded from participation.
  • Females of childbearing potential must have a negative pregnancy test and must be practicing a medically accepted means of contraception (including, but not limited to, condoms, diaphragms/caps, contraceptive pills, contraceptive rings/patches, intrauterine devices, hysterectomy or abstinence)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lisa Crujido, CCC-SLP

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Lisa Crujido, CCC-SLP

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20478461

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