Overview

Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
All
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 in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer. PURPOSE: This randomized phase II/III trial is studying ALTENS to see how well it works compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Treatments:
Pilocarpine
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