N/A
N=258
Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer
Radiation-Induced Xerostomia · Head and Neck Cancer · Radiation Toxicity · Oral Complications of Chemotherapy and Head/Neck Radiation
Bottom Line
View on ClinicalTrials.gov: NCT02589938 ↗Enrolled (actual)
258
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Xerostomia Questionnaire Scores — 57.3; 50.6; 55.0; 55.2 score on a scale 0-80 — p=0.0167
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Oral Hygiene (Other); Standard Oral Hygiene + True Acupuncture (Other); Standard Oral Hygiene + Sham Acupuncture (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Xerostomia Questionnaire Scores |
57.3; 50.6; 55.0; 55.2; 48.3; 51.2 | 0.0167 sig |
| SECONDARY Functional Assessment of Cancer Therapy (FACT-G) Total |
97.7; 101.6; 100.1; 99.5; 101.1; 100.1 | — |
| SECONDARY The Acupuncture Expectancy Scale (AES) |
10.8; 10.7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02589938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.