Acupressure on Xerostomia in Head and Neck Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Self-administered acupressure
BehavioralThe participants should perform self-administered acupressure 12 weeks after training
Oral health education
Other interventionThe participants should perform general oral care by themselves after the oral health education relating to xerostomia
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Self-administered acupressureExperimental treatment 1 intervention
Group B: Oral health educationActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 4 weeks, 12 weeks, and 24 weeksSecondary outcomes
1
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
Time frame
baseline, 12 weeks and 24 weeks2
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)
Time frame
baseline, 12 weeks and 24 weeks3
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.
Time frame
baseline, 12 weeks and 24 weeks4
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov