Clinical trial · Interventional
Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer
A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
NCT02589938CI-TRIAL-00104214ACUPUNCTUREcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Complications of Chemotherapy and Head/Neck Radiation | — | UNRESOLVED | — |
| Radiation-Induced Xerostomia | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Oral Hygiene | Other | — | UNRESOLVED |
| Standard Oral Hygiene + Sham Acupuncture | Other | — | UNRESOLVED |
| Standard Oral Hygiene + True Acupuncture | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard Oral Hygiene
- 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.
- interventionNames
- Other: Standard Oral Hygiene
- type
- EXPERIMENTAL
- label
- Standard Oral Hygiene + True Acupuncture
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCohen L, Danhauer SC, Garcia MK, Dressler EV, Rosenthal DI, Chambers MS, Cusimano A, Brown WM, Ochoa JM, Yang P, Chiang JS, Gordon O, Crutcher R, Kim JK, Russin MP, Lukenbill J, Porosnicu M, Yost KJ, Weaver KE, Lesser GJ. Acupuncture for Chronic Radiation-Induced Xerostomia in Head and Neck Cancer: A Multicenter Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410421. doi: 10.1001/jamanetworkopen.2024.10421. PMID 38739392