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Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT02474095
Recruitment Status : Active, not recruiting
First Posted : June 17, 2015
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE June 15, 2015
First Posted Date  ICMJE June 17, 2015
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE November 4, 2014
Actual Primary Completion Date October 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2015)
Change in XeQoLS [ Time Frame: Baseline to 15 months ]
A repeated measures model will be used to compare XeQoLS scores between the two arms at 15 months. Additional analysis will be performed using an area-under-the-curve (AUC) comparison of XeQoLS functional scores and the EORTC QLQ-C30 and the EORTC-QLQ-H&N35 scores between the two groups over time.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02474095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2015)
  • Change in the quality of life using the EORTC QLQ-C30 and the EORTC-QLQ-H&N35 [ Time Frame: Baseline to up to 21 months ]
    A repeated measures model will be used to compare EORTC QLQ-C30 and the EORTC-QLQ-H&N35 scores between the two arms. Additional analysis will be performed using an AUC comparison of XeQoLS functional scores and the EORTC QLQ-C30 and the EORTC-QLQ-H&N35 scores between the two groups over time.
  • Change in XeQoLS [ Time Frame: Baseline to up to 21 months ]
    A repeated measures model will be used to compare XeQoLS scores between the two arms. Additional analysis will be performed using an AUC comparison of XeQoLS functional scores and the EORTC QLQ-C30 and the EORTC-QLQ-H&N35 scores between the two groups over time.
  • Incidence of adverse events between treatment schedules using CTEP NCI CTCAE version 4.0 [ Time Frame: Up to 30 days after the last intervention or a new treatment is started ]
    The frequency of toxicities will be tabulated by grade.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
Official Title  ICMJE Two Versus Four Times-Weekly ALTENS for Treatment of Radiation-Induced Xerostomia: A Pilot Study
Brief Summary This randomized pilot clinical trial studies alternate schedules for acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) in treating dry mouth (xerostomia) caused by radiation therapy (RT) in patients with head and neck cancer. ALTENS is a procedure in which mild electric currents are applied to certain acupuncture points on the body and may help relieve dry mouth caused by RT and improve quality of life. It is not yet known whether giving ALTENS more frequently works better than standard ALTENS in treating dry mouth caused by RT.
Detailed Description

PRIMARY OBJECTIVES:

I. Determine whether ALTENS treatment using a four-times weekly schedule for 6 weeks reduces overall xerostomia burden, using the University of Michigan 15-item Xerostomia-related Quality of Life Scale (XeQoLS), compared to the standard ALTENAS schedule of twice-weekly for 12 weeks, at 15 months from the start of ALTENS treatment.

SECONDARY OBJECTIVES:

I. Determine whether ALTENS treatment using a four-times weekly schedule for 6 weeks reduces overall xerostomia burden, using the University of Michigan 15-item Xerostomia-related Quality of Life Scale (XeQoLS), compared to the standard ALTENS schedule of twice-weekly for 12 weeks, at 6, 9, 15, and 21 months from the start of ALTENS treatment.

II. Examine the benefit of ALTENS treatment using a four-times weekly schedule for 6 weeks on overall quality of life, using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire, QLQ-C30, including the questionnaire module specific to head and neck cancers (QLQ-H&N35), compared to the standard ALTENS schedule of twice-weekly for 12 weeks, at 6, 9, 15, and 21 months from the start of ALTENS treatment.

III. To compare the toxicity between treatment schedules using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo ALTENS delivered via the Codetron machine four times weekly (QIW) for 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo ALTENS delivered via the Codetron machine twice-weekly (BIW) for 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6, 9, 15, and 21 months.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Head and Neck Carcinoma
  • Xerostomia
Intervention  ICMJE
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Procedure: Transcutaneous Acupoint Electrical Stimulation
    Undergo ALTENS
    Other Names:
    • acupuncture-like transcutaneous electrical nerve stimulation
    • ALTENS
    • TAES
Study Arms
  • Experimental: Arm I (ALTENS QIW)
    Patients undergo ALTENS delivered via the Codetron machine QIW for 6 weeks in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Other: Quality-of-Life Assessment
    • Procedure: Transcutaneous Acupoint Electrical Stimulation
  • Active Comparator: Arm II (ALTENS BIW)
    Patients undergo ALTENS delivered via the Codetron machine BIW for 12 weeks in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Other: Quality-of-Life Assessment
    • Procedure: Transcutaneous Acupoint Electrical Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 15, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date October 12, 2019
Actual Primary Completion Date October 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Must have received and completed radiotherapy with or without chemotherapy for head and neck cancer; time from completion of radiotherapy to registration must be at least 3 months and up to a maximum of 1 year
  • Have grade 1 or 2 symptomatic dry mouth (xerostomia) according to CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
  • Have complete history and physical examination documenting no clinical evidence of disease within 8 weeks of registration
  • After completion of radiotherapy, within the last 12 months, a positron emission tomography (PET)/computed tomography (CT) or contrast-enhanced CT scan must be performed within 8 weeks of registration demonstrating no evidence of disease or loco-regional recurrence
  • Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Patients with normal saliva production (no salivary gland changes; no xerostomia)
  • Patients who are on pilocarpine for ophthalmic or non-ophthalmic indications
  • Patients who are on regular medications which will induce xerostomia (tricyclic antidepressants, antihistamines with anticholinergic effects)
  • Patients with Sjogren's syndrome
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or nursing female patients
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive ALTENS
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02474095
Other Study ID Numbers  ICMJE I 247213
NCI-2015-00823 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 247213 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Anurag Singh Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP