Electroacupuncture in Treating Chronic Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer

NCT00623129 | Terminated DMC

• 5 other identifiers: CDR0000583031P30CA015083MCS2852327-05NCI-2010-01835
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Electroacupuncture may help relieve chronic dry mouth caused by radiation therapy. It is not yet known whether electroacupuncture is more effective than a placebo in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer. PURPOSE: This randomized clinical trial is studying electroacupuncture to see how well it works compared with a placebo in treating chronic dry mouth caused by radiation therapy in patients with head and neck cancer.

Conditions

Head and Neck Cancer; Radiation Toxicity; Xerostomia

Keywords

hypopharyngeal cancer; lip and oral cavity cancer; laryngeal cancer; nasopharyngeal cancer; oropharyngeal cancer; paranasal sinus and nasal cavity cancer; salivary gland cancer; xerostomia; radiation toxicity

Outcome Measures

Primary Outcomes (3)

• Salivary flow as measured by sialometry at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment

• Subjective sensation of mouth dryness as measured by quality of life questionnaires at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment

• Quality of life as measured by quality of life questionnaires at baseline, on days 5 and 10 of treatment, and at 1, 3, and 6 months after completion of treatment

Interventions

questionnaire administration OTHER

electroacupuncture therapy PROCEDURE

management of therapy complications PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of primary head and neck cancer * Has undergone radiotherapy either as primary or adjuvant therapy ≥ 6 months ago * One or more parotid glands must have been in the prior radiotherapy field * Residual xerostomia after radiotherapy deemed to be significant by patient * Failed to respond to a trial of pilocarpine for relief of xerostomia PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Life expectancy ≥ 1 year (based on physician's judgment) * Able to attend the scheduled study treatments * Alert and mentally competent * Not pregnant * Willing to use contraception during study treatment, if of childbearing age * No history of Sjögren's disease * No cardiac pacemaker or any other electrical devices permanently implanted within the body (e.g., dorsal column stimulator) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 2 weeks since prior medication that may cause mouth dryness (e.g., antihistamines, narcotics, tricyclic antidepressants)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259-5499, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Injuries; Xerostomia; Hypopharyngeal Neoplasms; Mouth Neoplasms; Laryngeal Neoplasms; Nasopharyngeal Neoplasms; Oropharyngeal Neoplasms; Salivary Gland Neoplasms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Nasopharyngeal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Michele Y Halyard, M.D.

  Mayo Clinic Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: February 25, 2008
• Study Start: February 1, 2006
• Primary Completion: November 1, 2010
• Last Updated: April 19, 2016

Record last verified: 2011-08

Locations

US (1)