N/A
Completed N=170
Efficacy of Electrical Stimulation for Dysphagia in Head & Neck Cancer Patients
Source: ClinicalTrials.gov NCT00629265 ↗Enrolled (actual)
170
Serious AEs
11.2%
Results posted
Oct 2014
Primary outcomePrimary: Change in Penetration-Aspiration Scale (PAS) Score — 0.01; -0.57 Change in points on PAS
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Penetration-Aspiration Scale (PAS) Score |
0.01; -0.57 | — |
| SECONDARY Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI) |
6.25; 4.52; 6.31; 6.74 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00629265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.