Acupressure on Xerostomia in Head and Neck Cancer Patients

NCT06465628 | Recruiting

• 1 other identifier: UW 24-233
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer; Xerostomia

Keywords

Self-administered acupressure; Xerostomia; Head and neck cancer; Quality of life

Outcome Measures

Primary Outcomes (1)

• Xerostomia Questionnaire

  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 Outcomes (6)

• Saliva flow

  baseline, 12 weeks and 24 weeks

• Quality of life for head and neck cancer patients

  baseline, 12 weeks and 24 weeks

• Symptom severity

  baseline, 12 weeks and 24 weeks

• Sociodemographic characteristics

  Baseline

• Acceptability

  12 week

Study Arms (2)

Self-administered acupressure

EXPERIMENTAL

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

Oral health education

ACTIVE COMPARATOR

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

Interventions

Self-administered acupressure BEHAVIORAL

The participants should perform self-administered acupressure 12 weeks after training

Self-administered acupressure

Oral health education OTHER

The participants should perform general oral care by themselves after the oral health education relating to xerostomia

Oral health education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, 000000, Hong Kong

RECRUITING

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MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia

Interventions

Health Education, Dental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Dentistry; Environment and Public Health

Study Officials

• Denise Cheung, PhD

  School of Nursing, the University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Cheung, PhD

CONTACT

39176673; denisest@hku.hk

Xueyan Cheng, Master

CONTACT

93569604; u3009142@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 28, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)