Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer

PRIMARY OBJECTIVES:

I. Determine whether ALTENS treatment using a four-times weekly schedule for 6 weeks reduces
overall xerostomia burden, using the University of Michigan 15-item Xerostomia-related
Quality of Life Scale (XeQoLS), compared to the standard ALTENAS schedule of twice-weekly for
12 weeks, at 15 months from the start of ALTENS treatment.

SECONDARY OBJECTIVES:

I. Determine whether ALTENS treatment using a four-times weekly schedule for 6 weeks reduces
overall xerostomia burden, using the University of Michigan 15-item Xerostomia-related
Quality of Life Scale (XeQoLS), compared to the standard ALTENS schedule of twice-weekly for
12 weeks, at 6, 9, 15, and 21 months from the start of ALTENS treatment.

II. Examine the benefit of ALTENS treatment using a four-times weekly schedule for 6 weeks on
overall quality of life, using the European Organization for Research and Treatment of Cancer
(EORTC) quality of life questionnaire, QLQ-C30, including the questionnaire module specific
to head and neck cancers (QLQ-H&N35), compared to the standard ALTENS schedule of
twice-weekly for 12 weeks, at 6, 9, 15, and 21 months from the start of ALTENS treatment.

III. To compare the toxicity between treatment schedules using the Cancer Therapy Evaluation
Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE Version 4.0).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo ALTENS delivered via the Codetron machine four times weekly (QIW) for
6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo ALTENS delivered via the Codetron machine twice-weekly (BIW) for 12
weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6, 9, 15, and 21 months.

Inclusion Criteria:

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Must have received and completed radiotherapy with or without chemotherapy for head
and neck cancer; time from completion of radiotherapy to registration must be at least
3 months and up to a maximum of 1 year

- Have grade 1 or 2 symptomatic dry mouth (xerostomia) according to CTEP NCI Common
Terminology Criteria for Adverse Events (CTCAE version 4.0)

- Have complete history and physical examination documenting no clinical evidence of
disease within 8 weeks of registration

- After completion of radiotherapy, within the last 12 months, a positron emission
tomography (PET)/computed tomography (CT) or contrast-enhanced CT scan must be
performed within 8 weeks of registration demonstrating no evidence of disease or
loco-regional recurrence

- Patients of child-bearing potential must agree to use adequate contraceptive methods
(e.g., hormonal or barrier method of birth control; abstinence) prior to study entry;
should a woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician immediately

- Patient or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Patients with normal saliva production (no salivary gland changes; no xerostomia)

- Patients who are on pilocarpine for ophthalmic or non-ophthalmic indications

- Patients who are on regular medications which will induce xerostomia (tricyclic
antidepressants, antihistamines with anticholinergic effects)

- Patients with Sjogren's syndrome

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant or nursing female patients

- Unwilling or unable to follow protocol requirements

- Any condition which in the investigator's opinion deems the patient an unsuitable
candidate to receive ALTENS