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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Xerostomia

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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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Successful delivery of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) treatment using the Codetron™ unit (phase II)

Safety Issue:

No

Principal Investigator

Raimond K. W. Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre

Authority:

United States: Federal Government

Study ID:

CDR0000592644

NCT ID:

NCT00656513

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Xerostomia
  • hypopharyngeal cancer
  • laryngeal cancer
  • lip and oral cavity cancer
  • nasopharyngeal cancer
  • paranasal sinus and nasal cavity cancer
  • oropharyngeal cancer
  • salivary gland cancer
  • metastatic squamous neck cancer with occult primary
  • xerostomia
  • tongue cancer
  • Head and Neck Neoplasms
  • Xerostomia

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
Hospital of Saint RaphaelNew Haven, Connecticut  06511
Boston University Cancer Research CenterBoston, Massachusetts  02118
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
Emory Crawford Long HospitalAtlanta, Georgia  30308
Bloomington Hospital Regional Cancer InstituteBloomington, Indiana  47403