Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Head and Neck Cancer, Xerostomia
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, paranasal sinus and nasal cavity cancer, oropharyngeal cancer, salivary gland cancer, metastatic squamous neck cancer with occult primary, xerostomia, tongue cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of head and neck cancer
- No clinical evidence of disease recurrence by ear, nose, and throat exam with a nasopharyngeal scope, if indicated, 8 weeks prior to registration
Completed radiotherapy (i.e., standard or intensity-modulated radiotherapy) with or without chemotherapy ≥ 3 months and up to 2 years prior to study entry
- Grade 1-2 radiotherapy-induced xerostomia according to the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.3.0 and the dry mouth/salivary gland xerostomia scale
- Must have evidence of residual salivary function with unstimulated (basal) whole salivary production ≥ 0.1 ml/min after having refrained from eating or drinking oral fluid for 2 hours
- No patients with normal saliva production (i.e., no salivary gland changes or no xerostomia)
- No history of serious adverse events after prior treatment with and discontinuation of pilocarpine
- No chronic lymphocytic leukemia
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Zubrod performance status of 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other invasive malignancy except non-melanomatous skin cancer or cancer from which the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix)
- No concurrent contraindications to pilocarpine (e.g., uncontrolled asthma, miosis, or hypersensitivity)
No severe, active co-morbidity, including any of the following:
- Unstable cardiac disease or requirement for a pacemaker in-situ
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- No Sjögren syndrome
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 2 weeks since prior pilocarpine or cevimeline and no concurrent use for ophthalmic or non-ophthalmic indications
- No concurrent regular medications that induce xerostomia (e.g., tricyclic antidepressants, antihistamines with anticholinergic effects, or narcotics)
- No concurrent oral stimulating agents or salivary gland medical stimulants
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer Center
- Hospital of Saint Raphael
- Emory Crawford Long Hospital
- Winship Cancer Institute of Emory University
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Bloomington Hospital Regional Cancer Institute
- Center for Cancer Care at Goshen General Hospital
- Methodist Cancer Center at Methodist Hospital
- Boston University Cancer Research Center
- CCOP - St. Louis-Cape Girardeau
- Roswell Park Cancer Institute
- Blumenthal Cancer Center at Carolinas Medical Center
- Case Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Oklahoma University Cancer Institute
- Schiffler Cancer Center at Wheeling Hospital
- Maisonneuve-Rosemont Hospital
- Hopital Notre-Dame du CHUM
- McGill Cancer Centre at McGill University
- Centre Hospitalier Universitaire de Quebec
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Pilocarpine: Phase III
ALTENS: Phase III
ALTENS: Phase II