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NCT02589938 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2026-02-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Xerostomia Questionnaire Scores

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outcome · POSTED

Functional Assessment of Cancer Therapy (FACT-G) Total

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outcome · POSTED

The Acupuncture Expectancy Scale (AES)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Other: Standard Oral Hygiene
    label
    Standard Oral Hygiene
    type
    ACTIVE_COMPARATOR
  2. 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.
    intervention Names
    1. Other: Standard Oral Hygiene + True Acupuncture
    label
    Standard Oral Hygiene + True Acupuncture
    type
    EXPERIMENTAL
  3. 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.
    intervention Names
    1. Other: Standard Oral Hygiene + Sham Acupuncture
    label
    Standard Oral Hygiene + Sham Acupuncture
    type
    OTHER
interventions
  1. arm Group Labels
    1. Standard Oral Hygiene
    description
    Oral hygiene care provided per individual institutions standard of care.
    name
    Standard Oral Hygiene
    other Names
    1. Oral Hygiene
    type
    OTHER
  2. arm Group Labels
    1. Standard Oral Hygiene + True Acupuncture
    description
    Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
    name
    Standard Oral Hygiene + True Acupuncture
    type
    OTHER
  3. arm Group Labels
    1. Standard Oral Hygiene + Sham Acupuncture
    description
    Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
    name
    Standard Oral Hygiene + Sham Acupuncture
    other Names
    1. Placebo acupuncture needle
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
  3. OUTCOMES_ASSESSOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
258
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Xerostomia Questionnaire Scores
    time Frame
    Baseline to 4, 8, 12, 26 weeks post acupuncture
secondary Outcomes
  1. description
    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
    measure
    Functional Assessment of Cancer Therapy (FACT-G) Total
    time Frame
    Baseline, 4 , 8 , 12, and 26 weeks
  2. description
    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.
    measure
    The Acupuncture Expectancy Scale (AES)
    time Frame
    Week 4
Full study description
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. Ear point locations will mimic standard practice and be identified by the acupuncturists.
Source references
references
  1. citation
    Cohen 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
    type
    DERIVED
Source notices and limitations
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    Preserved source evidence · Not medical advice