Acupressure on Xerostomia in Head and Neck Cancer Patients
NCT Number: NCT06465628
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Cancer|Xerostomia
Interventions: BEHAVIORAL: Self-administered acupressure|OTHER: Oral health education
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-15
Completion Date: 2026-03-31
Locations: Queen Mary Hospital, Hong Kong, 000000, Hong Kong

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.

Primary Outcome Measures: 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 Outcome Measures: Saliva flow, 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, 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, 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, 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|Acceptability, 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|Acupressure Expectancy Scale, The Acupressure Expectancy Scale consists of 4 items using a five-point scale, with higher score indicating higher expectations (score range, 0-16), Baseline