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

Xerostomia Clinical Trial

Official title:

Two Versus Four Times-Weekly ALTENS for Treatment of Radiation-Induced Xerostomia: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474095
• Other study ID #: I 247213
• Secondary ID: NCI-2015-00823I
• Status: Completed
• Phase: N/A
• Start date: November 4, 2014
• Est. completion date: October 12, 2019

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 12, 2019
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Xerostomia

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies

Procedure:
• Transcutaneous Acupoint Electrical Stimulation
Undergo ALTENS

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 15 months
Secondary	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.	Baseline to up to 21 months
Secondary	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.	Baseline to up to 21 months
Secondary	Incidence of adverse events between treatment schedules using CTEP NCI CTCAE version 4.0	The frequency of toxicities will be tabulated by grade.	Up to 30 days after the last intervention or a new treatment is started