Status:
COMPLETED
Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Head and Neck Cancer
Xerostomia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which remedy is more effective ...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility of successfully delivering acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) using the Codetron™ unit in a cooperative group setti...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00656513
Start Date
September 1 2008
End Date
November 1 2014
Last Update
November 19 2019
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
3
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
4
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322