Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer

Not Applicable

Completed

• Conditions: Radiation Toxicity; Oral Complications of Chemotherapy and Head/Neck Radiation; Radiation-Induced Xerostomia; Head and Neck Cancer
• Interventions: Other: Standard Oral Hygiene + Sham Acupuncture; Other: Standard Oral Hygiene; Other: Standard Oral Hygiene + True Acupuncture

• Registration Number: NCT02589938
• Lead Sponsor: Wake Forest University Health Sciences

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. Earpoint locations will mimic standard practice and be identified by the acupuncturists.

Study Timeline

• Study Start: 2012-11-11
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Status Verified: 2022-07
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 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 ECOG performance status of 0-2.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Oral Hygiene + Sham Acupuncture	Standard Oral Hygiene + Sham Acupuncture	All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points.
Standard Oral Hygiene	Standard Oral Hygiene	All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site.
Standard Oral Hygiene + True Acupuncture	Standard Oral Hygiene + True Acupuncture	All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes.

Primary Outcome Measures

Name	Time	Method
Xerostomia Questionnaire Scores	Baseline to 4, 8, 12, 26 weeks post acupuncture	Self reported Xerostomia questionnaire consists of eight items (scored on an 11-point scale; 0-10), has been validated in several cohorts, and is regarded as the gold-standard measure for xerostomia.The questions are equally divided into 4 items about oral dryness while eating or chewing and 4 items about dryness while not eating or chewing. Item scores are summed and transformed linearly to produce a final summary score between 0 and 80. Higher scores represent more xerostomia. Questionnaire is completed prior to randomization and at each time point week 4, week 8, week 12, and end of study.

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy (FACT-G) Total	Baseline, 4 , 8 , 12, and 26 weeks	The FACT-G QOL instrument discriminates between individuals with metastatic and non-metastatic disease, as well as between patients at different stages of illness. The scale has good concurrent validity, high internal consistency (0.89), and good test-re-test reliability (0.82 to 0.88). The total score is reported, which is a combination of the subscales of physical, social/family, emotional, and functional well-being, with higher scores representing better QOL. Scale range 0-108
The Acupuncture Expectancy Scale (AES)	baseline to week 4	The 4-item AES was used to ensure there were no baseline group differences in expectations related to the benefits of acupuncture on dry mouth and to assess aspects of blinding after the first 4 weeks of acupuncture for the TA and SA groups. The AES is reliable (α=0·82) and valid by positive correlation with patient self-reported efficacy and satisfaction. The scale has been further validated among cancer patients who were acupuncture naïve. Scale from 4-20.

Trial Locations

Locations (36)

Kaiser Permanente Medical Center - Santa Clara; 🇺🇸 Santa Clara, California, United States

Physicians' Clinic of Iowa PC; 🇺🇸 Cedar Rapids, Iowa, United States

Saint Luke's Hospital; 🇺🇸 Cedar Rapids, Iowa, United States

MD Anderson in The Woodlands; 🇺🇸 Conroe, Texas, United States

Fairview Southdale Hospital; 🇺🇸 Edina, Minnesota, United States

Prisma Health Cancer Institute - Seneca; 🇺🇸 Seneca, South Carolina, United States

Mercy Health Saint Mary's; 🇺🇸 Grand Rapids, Michigan, United States

John H Stroger Jr Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

Park Nicollet Clinic - Saint Louis Park; 🇺🇸 Saint Louis Park, Minnesota, United States

Kaiser Permanente-San Rafael; 🇺🇸 San Rafael, California, United States

Kaiser San Rafael-Gallinas; 🇺🇸 San Rafael, California, United States

Mercy Hospital; 🇺🇸 Coon Rapids, Minnesota, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Columbus Oncology and Hematology Associates Inc; 🇺🇸 Columbus, Ohio, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Meharry Medical College; 🇺🇸 Nashville, Tennessee, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

MD Anderson West Houston; 🇺🇸 Houston, Texas, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center; 🇺🇸 Burbank, California, United States

Kaiser Permanente-Santa Teresa-San Jose; 🇺🇸 San Jose, California, United States

Kaiser Permanente-Santa Rosa; 🇺🇸 Santa Rosa, California, United States

Kaiser Permanente-San Francisco; 🇺🇸 San Francisco, California, United States

Kaiser Permanente-Walnut Creek; 🇺🇸 Walnut Creek, California, United States

Kaiser Permanente-South San Francisco; 🇺🇸 South San Francisco, California, United States

Spectrum Health at Butterworth Campus; 🇺🇸 Grand Rapids, Michigan, United States

University of New Mexico Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States

Christus Saint Vincent Regional Cancer Center; 🇺🇸 Santa Fe, New Mexico, United States

Adena Regional Medical Center; 🇺🇸 Chillicothe, Ohio, United States

Prisma Health Cancer Institute - Spartanburg; 🇺🇸 Boiling Springs, South Carolina, United States

Prisma Health Greenville Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside; 🇺🇸 Greenville, South Carolina, United States

Providence Regional Cancer System-Lacey; 🇺🇸 Lacey, Washington, United States

Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

University of Hawaii Cancer Center; 🇺🇸 Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha; 🇺🇸 Honolulu, Hawaii, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States