Acupressure on Xerostomia in Head and Neck Cancer Patients

May 26, 2025 updated by: Cheung Shuk-Ting, The University of Hong Kong

Effect of Self-administered Acupressure for Improving Xerostomia in Head and Neck Cancer Patients: a Randomized Controlled Trial

This is a randomized controlled trial aimed to1) examine the effect of a self-administered acupressure intervention on head and neck cancer patients with xerostomia (primary outcome) relative to oral health education control; 2) examine the effect of self-administered acupressure on secondary outcomes, including quality of life and severity of symptoms of head and neck cancer patients; 3) evaluate patients' expectancy of acupressure; 4) explore the acceptability of self-administered acupressure for head and neck cancer patients with xerostomia.

Hypothesis: self-administered acupressure has better effect on xerostomia for head and neck cancer patients comparing to oral health education. Acupressure will also benefit head and neck cancer patients on quality of life and severity of symptoms. Head and neck cancer patients may have good acceptability of self-administered acupressure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Xerostomia is defined as "the subjective sensation of dryness of the mouth". It is common in patients with acute/chronic medical conditions, especially in patients with cancer. Results from observational studies reported 40% to 75% prevalence of xerostomia among cancer patients. Head and neck cancer patients, as the seventh most common type of cancer, reported an even higher prevalence (80%) of xerostomia after treatment compared with other cancer types. Despite the high prevalence of xerostomia, it is often underrecognized by patients and healthcare providers.

Xerostomia in head and neck cancer patients is largely induced by radiation in the head and neck region, which can damage salivary glands, and thereby change the volume, consistency, and pH of their saliva. Besides, xerostomia may be caused or exacerbated by the concomitant or sequential use of chemotherapy agents and other drugs (e.g., opioid). Consistent lacking saliva in cancer patients can lead to increased risk of oral fungal infection, caries, swallowing problems, sleep problems, depression, fatigue and altered taste, which may even result in poor nutritional status. Furthermore, xerostomia may become a chronic and even irreversible side effect.

Current therapies for xerostomia in cancer patients include both pharmacological and non-pharmacological treatments. Pharmacotherapy has been considered as a general treatment for stimulating saliva secretion in alleviating xerostomia for head and neck cancer patients. However, the evidence of pharmacological interventions (e.g., pilocarpine, bethanechol, amifostin, cevimeline and palifermin) on xerostomia is insufficient, and the use of pharmacotherapy may cause some common adverse effects, including nausea, sweating, nervousness, and urinary frequency. Non-pharmacological treatments such as saliva stimulants (e.g. citric and malic acids, chewing gum, toothpaste and lozenges) and saliva substitute (e.g. liquids, gels and sprays) have also been suggested to treat xerostomia, but neither with sufficient evidence of significant effect, and may also lead to adverse effects (e.g., nausea, unpleasant taste, diarrhea, and tooth mineralization). Some patients may find regular sips of water useful, but only for temporary benefit, because saliva is a complex substance with irreplaceable functions (antibacterial and immunologic protection). Therefore, an evidence-based effective strategy with few adverse events is warranted for head and neck cancer patients with xerostomia.

Both acupressure and acupuncture aim to improve health and cure illnesses by improving energy flow through stimulating meridian points. Acupressure is a non-invasive technique of activating acupoints using hands, fingers, or thumbs along the meridians, while acupuncture involves the use of needles. Stimulation on acupoints may increase the flow of blood and qi along the related meridians, as well as stimulate the local blood flow around the salivary glands, thereby increasing salivary secretion. Also, acupressure/acupuncture may stimulate the parasympathetic nervous system, hence indirectly stimulate salivary glands secretion. Besides, microcirculation may be promoted through the release of sensory neuropeptides, so as to increase the tissue oxygenation and metabolism. Some studies had demonstrated positive effect of acupuncture on xerostomia for head and neck cancer patients, while none examined acupressure. Based on the same meridian theory, both acupuncture and acupressure were widely applied to the symptom management (e.g. fatigue, nausea, pain) for cancer patients, effectively with good adherence. Compared to acupuncture, acupressure can be administered by patients themselves after training. The purpose of this study is to examine the effect of self-administered acupressure on xerostomia for head and neck cancer patients.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • Recruiting
        • Queen Mary Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age ≥18 years;
  • able to give informed consent;
  • diagnosed with head and neck cancer (cancers in the head and neck region, e.g. oral cancer, nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, sinus cancer, salivary gland cancer);
  • completed radiation therapy or chemoradiotherapy for at least 2 weeks;
  • complains of xerostomia after the treatment;
  • able to communicate in Cantonese or Mandarin.

Exclusion Criteria:

  • history of xerostomia prior to head and neck cancer treatment (e.g., Sjögren Syndrome);
  • practiced acupressure or received acupuncture in the last 3 months;
  • having contraindications to acupressure, e.g. blood system disease (e.g., leukemia); pregnancy; lactating; upper or lower extremity deformities; infection or injuries at the acupoints.

Those who are taking medications/alternative substances to treat xerostomia on a fixed dosage regimen in the past one month will not be excluded.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-administered acupressure
Participants will attend a 90-min self-administered acupressure training session by a registered Traditional Chinese Medicine practitioner. A follow-up session will be arranged in the second week to reinforce learning and to make sure all participants can locate the proposed acupoints correctly. The follow up session will be conducted face to face (prioritized mode), or by phone/video call based on patients' preference. The acupoints are chosen for inclusion in the protocol based on literature review [25, 29, 34, 35, 39] and expert experience of the PI [40-43]. The location of acupoints (nine in total) include face and neck (Ren 23, Ren 24, ST5, ST6, ST7, TE17), upper limbs (LI2, LI4), and lower limbs (KI6). All acupoints should be massaged bilaterally except Ren 23 and Ren 24. After the training, participants are encouraged to self-administered acupressure on the acupoints twice daily for 12 weeks, each point lasting for 1 minute.
Behavioral: Self-administered acupressure
The participants should perform self-administered acupressure 12 weeks after training
Active Comparator: Oral health education

Participants will attend a 90-min oral care education session in the first week by a trained research staff (the same frequency and duration as the intervention group). The content includes the causes of xerostomia, consequences, current preventative measures, dietary advice and oral hygiene advice.

Participants in the control group will receive a booklet documenting the content of the oral care education sessions. Throughout the 12-week period, participants will receive reminders of oral care for xerostomia twice weekly
Other: Oral health education
The participants should perform general oral care by themselves after the oral health education relating to xerostomia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Xerostomia Questionnaire
Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks
Self-reported severity of xerostomia will be measured using the Xerostomia Questionnaire at baseline, 4 weeks, 12 weeks and 24 weeks. It consists of 8 items on an 11-point scale (0-80), which has been validated in several cohorts, and is regarded as the criterion standard for measuring xerostomia, which has been used for patients with head and neck cancer. Higher score refers to higher level in xerostomia. After adding item scores, the sum is transformed linearly to produce a final summary score between 0 and 100. Higher scores represent higher level of xerostomia. It suggested that an XQ score ≤30 refers to mild to no symptoms of xerostomia.
Baseline, 4 weeks, 12 weeks, and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 12 week
Acceptability of the intervention will be measured in terms of training and self-practice adherence. Training adherence is defined as the percentage of patients who completed the two intervention sessions. Self-practice adherence is defined as the proportion of participants completing more than 70% of prescribed self-practice. Overall adherence is defined as the proportion of participants completing the two intervention sessions and more than 70% of prescribed self-practice
12 week
Saliva flow
Time Frame: baseline, 12 weeks and 24 weeks
Objectively measured severity of xerostomia will be measured using modified Schirmer strips between 9 am to 12 pm. The modified Schirmer test is an objective, well-tolerated test for measuring mouth dryness for head and neck cancer patients. Before performing the test, all the participants should refrain from eating and drinking for at least 15 min. The participants will be asked to swallow once before the measurement. Unstimulated saliva will be measured by inserting a test strip to the floor of the mouth for three minutes (remove the strip for two to three second and to read the test strip at 1-minute, 2-minute and 3-minute respectively, with one-minute interval between each reading). Then, patients will have fresh lemon juice applied with cotton-tipped applicators to the lateral tongue bilaterally five times(apply at 0, 30s, 60s, 90s and 120s respectively). The stimulated saliva will be collected in the same manner as for unstimulated saliva
baseline, 12 weeks and 24 weeks
Quality of life for head and neck cancer patients
Time Frame: baseline, 12 weeks and 24 weeks
European Organisation for Research and Treatment of Cancer Quality of Life-Head and Neck cancer (EORTC QLQ-HN35) will be used to estimate the quality of life for head and neck cancer patients. The standardized sum scores range from 0 to 100, with a higher score indicating a greater degree of symptoms (worse QOL)
baseline, 12 weeks and 24 weeks
Symptom severity
Time Frame: baseline, 12 weeks and 24 weeks
MD Anderson Symptom Inventory-Head and Neck (MDASI-HN) will be used to measure the severity of different cancer symptoms and the interference of symptoms with patients' daily activities at baseline, 12 weeks and 24 weeks. MDASI-HN consists of 28 items, and the range of scores is 0-280, with a higher degree indicating a greater degree of symptoms. The scale has been validated in studies evaluating symptom severity and daily activities for head and neck cancer patients.
baseline, 12 weeks and 24 weeks
Sociodemographic characteristics
Time Frame: Baseline
The sociodemographic characteristics will be collected at baseline, such as age, gender, education levels, employment, marital status (single/married/cohabitating/divorced), income levels, smoking/drinking status, comorbidities, cancer types, cancer stage, cancer treatment, and time since finishing the cancer treatment.
Baseline
Acupressure Expectancy Scale
Time Frame: Baseline
The Acupressure Expectancy Scale consists of 4 items using a five-point scale, with higher score indicating higher expectations (score range, 0-16)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Denise Cheung, PhD, School of Nursing, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are not to share IPD. All IPD for patients will be collected and analyzed confidentially, they can only be identified with their unique ID in this study. Only members in this research team have access to the personal and study data during the validity period. The PI will be responsible for safekeeping of the study data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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