Clinical trial NCT02589938: Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer
Official title: A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation-Induced Xerostomia
Head and Neck Cancer
Radiation Toxicity
Oral Complications of Chemotherapy and Head/Neck Radiation
Keywords: hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
salivary gland cancer
radiation toxicity
xerostomia
long-term effects of cancer treatment
oral complications of radiation therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being done to find out what effects, good and/or bad, acupuncture has on participants and their xerostomia caused by radiation therapy for the treatment of the cancer.

Detailed description: Patients who have met all eligibility criteria will be randomized to standard oral hygiene, standard oral hygiene + true acupuncture twice weekly for 4 weeks, or standard oral hygiene + sham acupuncture twice weekly for 4 weeks by a form of adaptive randomization, called minimization, because simple randomization could result in covariate imbalances .

The acupuncture points will be at three sites on each ear (Shenmen, Point Zero, Salivary Gland 2-prime), a site on the chin (CV24), a site on each forearm (Lu7), a site on each hand (LI 1-prime), a site on each leg (K6), and one placebo needle at Gb32 for a total of 14 sites. All sites will be applied for 20 minutes. For body points, standardized techniques for location will be utilized, which are based on anatomical landmarks as well as proportional measurements using the patient's own body. For example, finger breadth is based on each patient's middle finger, and the proportional unit of measure, the "cun," is defined as the distance between the two medial ends of the creases of the interphalangeal joints when the middle finger is flexed. Ear point locations will mimic standard practice and be identified by the acupuncturists.

Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age and 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; IV fluids, pureed diet or tube feedings may be required)
  * Grade 4 - Fibrosis
* Must have received external beam radiation at a mean dose of at least 24 Gy to one of the parotid glands. The other gland can receive less than 24 Gy.
* Must have completed radiotherapy at least 12 months prior to entry.
* Must have anatomically intact parotid and submandibular glands. A focused (head/neck) history and exam conducted by a physician or dentist within the past year is required.
* Must be acupuncture naïve.
* 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 to the removed submandibular gland and will be exempt from this exclusion criteria.)
* Currently receiving or planning to use drugs, herbs, alternative medicines, or devices that could affect salivary production. Treatment known to affect salivation should be stopped at least 14 days prior to enrollment. Over the counter products used for salivary substitution are allowed, but will need to be discontinued for at least 24 hours prior to saliva and questionnaire data collection.
* 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.

Primary outcomes:
measure: Xerostomia Questionnaire Scores
timeFrame: Baseline to 4, 8, 12, 26 weeks post acupuncture
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy (FACT-G) Total
timeFrame: Baseline, 4 , 8 , 12, and 26 weeks
measure: The Acupuncture Expectancy Scale (AES)
timeFrame: baseline to week 4
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center/Disney Family Cancer Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente-San Francisco
state: California
city: San Jose
country: United States
facility: Kaiser Permanente-Santa Teresa-San Jose
state: California
city: San Rafael
country: United States
facility: Kaiser Permanente-San Rafael
state: California
city: San Rafael
country: United States
facility: Kaiser San Rafael-Gallinas
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center - Santa Clara
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente-Santa Rosa
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente-South San Francisco
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente-Walnut Creek
state: California
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: The Cancer Center of Hawaii-Liliha
state: Hawaii
city: Chicago
country: United States
facility: John H Stroger Jr Hospital of Cook County
state: Illinois
city: Cedar Rapids
country: United States
facility: Physicians' Clinic of Iowa PC
state: Iowa
city: Cedar Rapids
country: United States
facility: Saint Luke's Hospital
state: Iowa
city: Grand Rapids
country: United States
facility: Mercy Health Saint Mary's
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health at Butterworth Campus
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Santa Fe
country: United States
facility: Christus Saint Vincent Regional Cancer Center
state: New Mexico
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Oncology and Hematology Associates Inc
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Boiling Springs
country: United States
facility: Prisma Health Cancer Institute - Spartanburg
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Greenville Memorial Hospital
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Eastside
state: South Carolina
city: Seneca
country: United States
facility: Prisma Health Cancer Institute - Seneca
state: South Carolina
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Conroe
country: United States
facility: MD Anderson in The Woodlands
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson West Houston
state: Texas
city: Lacey
country: United States
facility: Providence Regional Cancer System-Lacey
state: Washington
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne C Danhauer, PhD
role: PRINCIPAL_INVESTIGATOR
References: