A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia

Trial Information

A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia

OBJECTIVES:

Primary

- Determine the feasibility of successfully delivering acupuncture-like transcutaneous
electrical nerve stimulation (ALTENS) using the Codetron™ unit in a cooperative group
setting in head and neck cancer patients with early radiotherapy-induced xerostomia.
(phase II)

- Compare the efficacy of ALTENS treatment vs pilocarpine hydrochloride in these patients
in reducing overall xerostomia burden, as measured by the University of Michigan
15-item Xerostomia-Related Quality of Life Scale (XeQOLS) at 9 months after
randomization. (phase III)

Secondary

- Evaluate the effect of ALTENS treatment on overall xerostomia burden at 6 months after
study entry in these patients. (phase II)

- Compare the efficacy of these treatments in these patients in reducing overall
xerostomia burden at 4, 6, and 15 months after randomization. (phase III)

- Compare the efficacy of these treatments in these patients in reducing symptom burden,
as measured by the four domains of the XeQOLS (i.e., physical functioning, social
functioning, personal/psychological functioning, and pain/discomfort) at 4, 6, 9, and
15 months after randomization. (phase III)

- Compare the efficacy of these treatments in these patients in increasing stimulated
(i.e., citric acid primed) whole salivary production (WSP), as measured by sialometry,
at 4, 6, 9, and 15 months after randomization. (phase III)

- Compare the efficacy of these treatments in these patients in increasing unstimulated
(i.e., basal primed) WSP, as measured by sialometry at 4, 6, 9, and 15 months after
randomization. (phase III)

- Compare adverse events associated with these treatments in these patients. (phase III)

OUTLINE: This is a phase II followed by a phase III multicenter study.

- Phase II:Patients undergo placement of surface electrodes at the following acupuncture
points: large intestine, spleen, stomach, and conception vessel. Patients then undergo
acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) to each of these
points using the Codetron™ unit for 20 minutes twice weekly for 12 weeks. No further
treatment is given after 12 weeks.

- Phase III:Patients are stratified according to prior use of pilocarpine (no vs yes) and
length of time from completion of chemotherapy and/or radiotherapy (3-6 months vs 6-12
months vs > 12 months). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral pilocarpine three times daily for up to 12 weeks in
the absence of disease progression or unacceptable toxicity.

- Arm II: Patients undergo ALTENS treatment using the Codetron™ unit twice weekly
for up to 12 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo quality of life (QOL) assessment at baseline and at 6 months after
registration in phase II. In phase III patients complete assessments for basal and
stimulated whole salivary production, xerostomia burden, and QOL at baseline and at 4, 6, 9,
and 15 months after study entry.

After completion of study therapy, patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 45 patients will be accrued to the phase II portion and 144
patients to the phase III portion of this study.