Acupuncture in Treating Dry Mouth Caused by Radiation Therapy in Patients with Head and Neck Cancer

Status: Active

Description

This randomized phase III trial studies acupuncture to see how well it works compared to sham acupuncture or standard therapy in treating dry mouth caused by radiation therapy (xerostomia) in patients with head and neck cancer. Acupuncture may help relieve dry mouth caused by radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent
  • Must be able to read, write and understand English
  • Must have a diagnosis of head/neck cancer
  • Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified Radiation Therapy Oncology Group (RTOG) scale: * Grade 0 – None * Grade 1 – Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary) * Grade 2 – Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods) * Grade 3 – Complete dryness of mouth (no response on stimulation and difficult oral alimentation; intravenous (IV) fluids, pureed diet or tube feedings may be required) * Grade 4 – Fibrosis
  • Must have received external beam radiation with curative intent
  • Must have completed radiotherapy at least 12 months prior to entry
  • Must have anatomically intact parotid glands and at least one submandibular gland; a focused (head/neck) history and exam conducted by a physician or dentist within the past year is required
  • Have never had acupuncture for xerostomia
  • Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria

  • History of xerostomia, Sjogren’s disease or other illness known to affect salivation prior to head/neck radiation
  • Suspected or known closure of salivary gland ducts on either side. (Patients addressed in inclusion criteria (i.e. those who have had one submandibular gland removed) are expected to have closure of the duct to the removed submandibular gland and will be exempt from this exclusion criteria.)
  • Currently receiving or planning to receive other xerostomia treatment, including drugs, herbs or devices; all other treatments known to affect salivation should be stopped at least 14 days prior to enrollment
  • Have received any investigational new drug within the past 30 days or planning to receive such during the study period
  • Active systemic infection or skin infection at or near the acupuncture sites
  • Receiving chemotherapy during study period

Locations & Contacts

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu
San Francisco
Kaiser Permanente-San Francisco
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-713-6771
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-713-6771
San Rafael
Kaiser Permanente-San Rafael
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu
Kaiser San Rafael-Gallinas
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu
South San Francisco
Kaiser Permanente-South San Francisco
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-713-6771
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

Hawaii

Honolulu
Queen's Medical Center
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-713-6771
The Cancer Center of Hawaii-Liliha
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

Illinois

Chicago
John H Stroger Jr Hospital of Cook County
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

Iowa

Cedar Rapids
Physicians' Clinic of Iowa PC
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu
Saint Luke's Hospital
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-713-6771

Michigan

Grand Rapids
Mercy Health Saint Mary's
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-716-7402
Email: danhauer@wakehealth.edu
Spectrum Health at Butterworth Campus
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

Minnesota

Coon Rapids
Mercy Hospital
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-713-6771
Minneapolis
Hennepin County Medical Center
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-713-6771

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-716-7402
Email: danhauer@wakehealth.edu

Ohio

Chillicothe
Adena Regional Medical Center
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-713-6771
Columbus
Columbus Oncology and Hematology Associates Inc
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

Oregon

Portland
Providence Portland Medical Center
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

South Carolina

Greenville
Prisma Health Cancer Institute - Eastside
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-716-7402
Email: danhauer@wakehealth.edu
Prisma Health Greenville Memorial Hospital
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-716-7402
Email: danhauer@wakehealth.edu
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

Tennessee

Nashville
Meharry Medical College
Status: Active
Contact: Suzanne C. Danhauer
Phone: 336-713-6771

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Lorenzo Cohen
Phone: 713-745-4260
Email: lcohen@mdanderson.org
MD Anderson in Katy
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu
The Woodlands
MD Anderson in The Woodlands
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

Washington

Lacey
Providence Regional Cancer System-Lacey
Status: Active
Contact: Suzanne C. Danhauer
Email: danhauer@wfubmc.edu

Trial Objectives and Outline

PRIMARY OBJECTIVE:

I. To determine whether or not acupuncture can symptomatically improve moderate or severe xerostomia (grade 2 or 3) due to head/neck radiotherapy.

SECONDARY OBJECTIVES:

I. To explore the duration of response (up to a maximum of 6 months) in the subgroup of patients who report a response to the acupuncture intervention.

II. Examine group differences in saliva flow using unstimulated and stimulated whole salivary flow rates.

III. Examine whether true acupuncture results in better overall quality of life (QOL) than sham acupuncture or standard of care.

IV. Determine the effects of acupuncture on saliva-based factors including pH, buffering capacity, and viscosity as well as levels of total protein, calcitonin-gene related peptide, and vasoactive intestinal polypeptide.

V. Examine the role of expectancy for the benefits of acupuncture in predicting outcomes. The role of expectancy as a moderator of the effects of treatment will be thoroughly examined.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive standard oral hygiene care for 8 weeks, including instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice.

ARM II: Patients receive acupuncture at 3 sites on each ear, on the chin, on each forearm, on each hand, on each leg, and a placebo needle above the right knee for 20 minutes twice a week for 4 weeks. Patients with minor response may continue treatment for an additional 4 weeks. Patients also receive standard oral hygiene as in Arm I.

ARM III: Patients receive sham acupuncture twice a week for 4 weeks and standard oral hygiene as in Arm I. Patients with minor response may continue treatment for an additional 4 weeks.

After completion of study treatment, patients are followed up at 6 or 7.5 months.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Supportive care

Lead Organization

Lead Organization
Wake Forest NCORP Research Base

Principal Investigator
Suzanne C. Danhauer

Trial IDs

Primary ID MDA-04-01
Secondary IDs WF-97115, NCI-2011-02073, CDR0000674208, WFU 97115
Clinicaltrials.gov ID NCT01141231