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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIISupportive careActiveNot specifiedMDA-04-01
NCI-2011-02073, CDR0000674208, WFU 97115, WF-97115, NCT01141231

Trial 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.

Further Study Information


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


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.

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

Grade 2 – Moderate dryness of mouth

Grade 3 – Complete dryness of mouth

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

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Wake Forest NCORP Research Base

  • National Cancer Institute
Suzanne C. Danhauer, Principal Investigator

Trial Sites


Grand Rapids

Mercy Health Saint Mary's

Suzanne C. Danhauer
Ph: 336-716-7402

Suzanne C. Danhauer
Principal Investigator

North Carolina

Comprehensive Cancer Center of Wake Forest University

Suzanne C. Danhauer
Ph: 336-716-7402

Suzanne C. Danhauer
Principal Investigator

South Carolina

Greenville Health System Cancer Institute-Eastside

Suzanne C. Danhauer
Ph: 336-716-7402

Suzanne C. Danhauer
Principal Investigator

Greenville Memorial Hospital

Suzanne C. Danhauer
Ph: 336-716-7402

Suzanne C. Danhauer
Principal Investigator


M D Anderson Cancer Center

Lorenzo Cohen
Ph: 713-745-4260

Lorenzo Cohen
Principal Investigator

Link to the current record.
NLM Identifier NCT01141231

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the record via the link above for more information about participating sites.