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

NCT02474095 | Completed DMC

• 2 other identifiers: I 247213NCI-2015-00823
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma; Xerostomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the quality of life using the EORTC QLQ-C30 and the EORTC-QLQ-H&N35

  Baseline to up to 21 months

• Change in XeQoLS

  Baseline to up to 21 months

• Incidence of adverse events between treatment schedules using CTEP NCI CTCAE version 4.0

  Up to 30 days after the last intervention or a new treatment is started

Study Arms (2)

Arm I (ALTENS QIW)

EXPERIMENTAL

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

Other: Quality-of-Life Assessment; Procedure: Transcutaneous Acupoint Electrical Stimulation

Arm II (ALTENS BIW)

ACTIVE COMPARATOR

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

Other: Quality-of-Life Assessment; Procedure: Transcutaneous Acupoint Electrical Stimulation

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (ALTENS QIW); Arm II (ALTENS BIW)

Transcutaneous Acupoint Electrical Stimulation PROCEDURE

Undergo ALTENS

Also known as: acupuncture-like transcutaneous electrical nerve stimulation, ALTENS, TAES

Arm I (ALTENS QIW); Arm II (ALTENS BIW)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Anurag Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 17, 2015
• Study Start: November 4, 2014
• Primary Completion: October 12, 2018
• Study Completion: October 12, 2019
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)