Clinical trial NCT06465628: Acupressure on Xerostomia in Head and Neck Cancer Patients
Official title: Effect of Self-administered Acupressure for Improving Xerostomia in Head and Neck Cancer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Xerostomia
Keywords: Self-administered acupressure
Xerostomia
Head and neck cancer
Quality of life
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Xerostomia Questionnaire
timeFrame: Baseline, 4 weeks, 12 weeks, and 24 weeks
Secondary outcomes:
measure: Saliva flow
timeFrame: baseline, 12 weeks and 24 weeks
measure: Quality of life for head and neck cancer patients
timeFrame: baseline, 12 weeks and 24 weeks
measure: Symptom severity
timeFrame: baseline, 12 weeks and 24 weeks
measure: Sociodemographic characteristics
timeFrame: Baseline
measure: Acceptability
timeFrame: 12 week
measure: Acupressure Expectancy Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: School of Nursing, the University of Hong Kong
name: Denise Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
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