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

Wake Forest University (WFU)

Status: Completed

Conditions: Radiation-Induced Xerostomia; Radiation Toxicity; Head and Neck Cancer; Oral Complications of Chemotherapy and Head/Neck Radiation

Treatments: Other: Standard Oral Hygiene + True Acupuncture; Other: Standard Oral Hygiene + Sham Acupuncture; Other: Standard Oral Hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT02589938

NCI-2011-02073 (Registry Identifier)

IRB00038707

REBAWF 97115 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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258 participants in 3 patient groups

Standard Oral Hygiene

Active Comparator group

Description:

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.

Treatment:

Other: Standard Oral Hygiene

Standard Oral Hygiene + True Acupuncture

Experimental group

Description:

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.

Treatment:

Other: Standard Oral Hygiene + True Acupuncture

Standard Oral Hygiene + Sham Acupuncture

Other group

Description:

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.

Treatment:

Other: Standard Oral Hygiene + Sham Acupuncture