Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Supportive care	Temporarily closed	18 and over	NCI	RTOG-0537 RTOG 0537, NCT00656513

Objectives

Primary

1. 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)
2. 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

1. Evaluate the effect of ALTENS treatment on overall xerostomia burden at 6 months after study entry in these patients. (phase II)
2. Compare the efficacy of these treatments in these patients in reducing overall xerostomia burden at 4, 6, and 15 months after randomization. (phase III)
3. 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)
4. 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)
5. 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)
6. Compare adverse events associated with these treatments in these patients. (phase III)

Entry 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 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

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

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

Expected Enrollment

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

Outcomes

Successful delivery of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) treatment using the Codetron™ unit (phase II)
Overall xerostomia burden at 9 months after randomization, as measured by the University of Michigan 15-item Xerostomia Related Quality of Life Scale (XeQOLS) (phase III)

Beneficial treatment response, defined as a 20% improvement in overall xerostomia burden (XeQOLS score) from baseline to 6 months after study entry (phase II)
Overall xerostomia burden at 4, 6 and 15 months after randomization as measured by the XeQOLS (phase III)
Symptom burden at 4, 6, 9, and 15 months after randomization, as measured by the four domains of the XeQOLS: physical functioning, social functioning, personal/psychological functioning, and pain/discomfort (phase III)
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)
Unstimulated (i.e., basal primed) WSP as measured by sialometry at 4, 6, 9, and 15 months after randomization (phase III)
Adverse events as assessed by NCI CTCAE v.3.0

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.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Raimond Wong, MD, Principal investigator		Ph: 905-387-9495 ext. 64704

Registry Information
Official Title		A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia
Trial Start Date		2008-09-19
Trial Completion Date		2014-07-31 (estimated)
Registered in ClinicalTrials.gov		NCT00656513
Date Submitted to PDQ		2008-03-25
Information Last Verified		2009-08-13

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