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

Primary Purpose

Head and Neck Carcinoma, Xerostomia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Transcutaneous Acupoint Electrical Stimulation
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (ALTENS QIW)

Arm II (ALTENS BIW)

Arm Description

Patients undergo ALTENS delivered via the Codetron machine QIW for 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo ALTENS delivered via the Codetron machine BIW for 12 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Change in XeQoLS
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.

Secondary Outcome Measures

Change in the quality of life using the EORTC QLQ-C30 and the EORTC-QLQ-H&N35
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
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
The frequency of toxicities will be tabulated by grade.

Full Information

First Posted
June 15, 2015
Last Updated
July 20, 2022
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02474095
Brief Title
Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
Official Title
Two Versus Four Times-Weekly ALTENS for Treatment of Radiation-Induced Xerostomia: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 4, 2014 (Actual)
Primary Completion Date
October 12, 2018 (Actual)
Study Completion Date
October 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma, Xerostomia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (ALTENS QIW)
Arm Type
Experimental
Arm Description
Patients undergo ALTENS delivered via the Codetron machine QIW for 6 weeks in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II (ALTENS BIW)
Arm Type
Active Comparator
Arm Description
Patients undergo ALTENS delivered via the Codetron machine BIW for 12 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous Acupoint Electrical Stimulation
Other Intervention Name(s)
acupuncture-like transcutaneous electrical nerve stimulation, ALTENS, TAES
Intervention Description
Undergo ALTENS
Primary Outcome Measure Information:
Title
Change in XeQoLS
Description
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.
Time Frame
Baseline to 15 months
Secondary Outcome Measure Information:
Title
Change in the quality of life using the EORTC QLQ-C30 and the EORTC-QLQ-H&N35
Description
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.
Time Frame
Baseline to up to 21 months
Title
Change in XeQoLS
Description
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.
Time Frame
Baseline to up to 21 months
Title
Incidence of adverse events between treatment schedules using CTEP NCI CTCAE version 4.0
Description
The frequency of toxicities will be tabulated by grade.
Time Frame
Up to 30 days after the last intervention or a new treatment is started

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag Singh
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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