Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00656513
First received: April 10, 2008
Last updated: January 27, 2012
Last verified: December 2011
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Purpose
RATIONALE: Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) and pilocarpine may help to relieve chronic xerostomia (dry mouth). It is not yet known which remedy is more effective in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
PURPOSE: This randomized phase II/III trial is studying ALTENS to see how well it works compared with pilocarpine in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Xerostomia |
Drug: pilocarpine hydrochloride Procedure: acupuncture-like transcutaneous electrical nerve stimulation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Successful delivery of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) treatment using the Codetron™ unit (phase II) [ Designated as safety issue: No ]
- 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) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Beneficial treatment response, defined as a 20% improvement in overall xerostomia burden (XeQOLS score) from baseline to 6 months after study entry (phase II) [ Designated as safety issue: No ]
- Overall xerostomia burden at 4, 6 and 15 months after randomization as measured by the XeQOLS (phase III) [ Designated as safety issue: No ]
- 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) [ Designated as safety issue: No ]
- 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) [ Designated as safety issue: No ]
- Unstimulated (i.e., basal primed) WSP as measured by sialometry at 4, 6, 9, and 15 months after randomization (phase III) [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v.3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 189 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Phase III, arm I
Patients receive oral pilocarpine three times daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
|
Drug: pilocarpine hydrochloride
Given by mouth 3 times a day for up to 12 weeks
|
|
Experimental: Phase III, 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.
|
Procedure: acupuncture-like transcutaneous electrical nerve stimulation
Given twice a week for up to 12 weeks
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656513
Locations
| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Connecticut | |
| Hospital of Saint Raphael | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Georgia | |
| Emory Crawford Long Hospital | |
| Atlanta, Georgia, United States, 30308 | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Saint Anthony's Hospital at Saint Anthony's Health Center | |
| Alton, Illinois, United States, 62002 | |
| United States, Indiana | |
| Bloomington Hospital Regional Cancer Institute | |
| Bloomington, Indiana, United States, 47403 | |
| Center for Cancer Care at Goshen General Hospital | |
| Goshen, Indiana, United States, 46526 | |
| Methodist Cancer Center at Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Boston University Cancer Research Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Missouri | |
| CCOP - St. Louis-Cape Girardeau | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| United States, Ohio | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, West Virginia | |
| Schiffler Cancer Center at Wheeling Hospital | |
| Wheeling, West Virginia, United States, 26003 | |
| Canada, Quebec | |
| Hopital Notre-Dame du CHUM | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| McGill Cancer Centre at McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
| Principal Investigator: | Raimond K. W. Wong, MD | Margaret and Charles Juravinski Cancer Centre |
More Information
Additional Information:
Publications:
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00656513 History of Changes |
| Other Study ID Numbers: | CDR0000592644, RTOG-0537 |
| Study First Received: | April 10, 2008 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Xerostomia Neoplasms by Site Neoplasms Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Pilocarpine Miotics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Muscarinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013