Acupressure on Xerostomia in Head and Neck Cancer Patients
NCT ID: NCT06465628
Last Updated: 2025-05-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
126 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-12-01
Study Completion Date
2027-03-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Head and Neck Cancer
Xerostomia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Self-administered acupressure
Intervention Type
BEHAVIORAL
The participants should perform self-administered acupressure 12 weeks after training
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
Group Type
ACTIVE_COMPARATOR
Oral health education
Intervention Type
OTHER
The participants should perform general oral care by themselves after the oral health education relating to xerostomia
Interventions
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Self-administered acupressure
The participants should perform self-administered acupressure 12 weeks after training
Intervention Type
BEHAVIORAL
Oral health education
The participants should perform general oral care by themselves after the oral health education relating to xerostomia
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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.
\-
* 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.
\-
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Cheung Shuk-Ting
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Denise Cheung, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Nursing, the University of Hong Kong
Locations
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Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong
Site Status
RECRUITING
Countries
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Hong Kong
Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UW 24-233
Identifier Type: -
Identifier Source: org_study_id
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