A multicenter (RTOG and CCOP) phase II/III RCT of acupuncture-like TENS for radiotherapy-induced xerostomia is now recruiting patients.
June 2008 0537-1
RTOG Protocol No: 0537 Protocol Status: OPEN
Title: A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia
Patient Population:
Patients with no clinical evidence of disease recurrence (ENT exam with nasopharyngeal scope) within 8 weeks prior to registration. CT or MRI scan within 8 weeks prior to registration. Patients must have completed radiation (standard or IMRT) +/- chemotherapy at least 3 months prior to study entry.
Patients must have grade 1-2 xerostomia (CTCAE v3.0) at study entry. Patients must have evidence of residual salivary function with unstimulated WSP of at least 0.25 ml/min (having refrained from eating or drinking oral fluid for 2 hours prior).
Patients must discontinue use of pilocarpine within 2 weeks prior to randomization. Patients with previous adverse reactions to pilocarpine are not eligible. Zubrod performance status of 0-2 (lung patients must be 0-1). Patients with other prior invasive malignancy must have been disease free for at least 3 years. Patients on medications that induce xerostomia or patients with contraindications to pilocarpine are not eligible. Patients with unstable cardiac disease, acute bacterial or fungal infection requiring IV, or chronic obstructive pulmonary disease requiring hospitalization are not eligible. Patients must be at least 18 years of age and sign a study-specific informed consent prior to study entry. Serum pregnancy test for women of childbearing potential.
Objectives:
Primary:
• Phase II component
Determine the feasibility of successfully delivering the ALTENS treatment (given with the Codetron™
unit) in a cooperative group setting
• Phase III component
Determine whether the ALTENS treatment reduces overall xerostomia burden, as measured by the University of Michigan 15-item Xerostomia-Related Quality of Life Scale (XeQOLS), compared to the pilocarpine treatment at 9 months from randomization.
Secondary:
• Phase II component
Evaluate the effect of ALTENS treatment on overall xerostomia burden, as measured by the XeQOLS, at 6 months from registration.
• Phase III component
? Determine whether the ALTENS treatment reduces overall xerostomia burden, as measured by the XeQOLS, compared to the pilocarpine treatment at 4,6, and 15 months from randomization.
? Determine whether the ALTENS treatment reduces symptom burden in the four domains of the XeQOLS—physical functioning, social functioning, personal/psychological functioning, pain/discomfort— compared to the pilocarpine treatment at 4, 6, 9, and 15 months from randomization.
? Determine whether the ALTENS treatment increases stimulated (citric acid primed) whole salivary production (WSP), as measured by sialometry, compared to the pilocarpine treatment at 4, 6, 9, and 15 months from randomization.
? Determine whether the ALTENS treatment increases unstimulated (basal primed) WSP, as measured by sialometry, compared to the pilocarpine treatment at 4, 6, 9, and 15 months from randomization.
? Evaluate the potential benefit of ALTENS in change and overall quality of life, as measured by the University of Washington Head and Neck Questionnaire (UWHNSS).
? Compare adverse events between treatments according to CTCAE v.3.0 criteria.
Study Chairs: Raimond Wong, M.D. (Radiation Oncology) Stephen Sagar, M.D. (Radiation Oncology) Gwen Wyatt, Ph.D., R.N. (Symptom Management)
Statisticians: Thomas F. Pajak, Ph.D.
Jennifer James, M.S.
Research Associate: Roseann Bonanni, C.T.R., C.C.R.P.
Protocol Associate: Dana Robinson, M.Ed.
For more information and to join the study, contact: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
RTOG 0537 ALTENS for Xerostomia RCT
