Head and Neck CancerNCT06465628
Acupressure on Xerostomia in Head and Neck Cancer Patients
A study testing Self-administered acupressure and Oral health education in people with Head and Neck Cancer and Xerostomia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Xerostomia
- What is being tested?
- Self-administered acupressure and Oral health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, Hong Kong, 000000
Denise Cheung, Dr., 852-39176673, denisest@hku.hk
About this study
Official title: Effect of Self-administered Acupressure for Improving Xerostomia in Head and Neck Cancer Patients: a Randomized Controlled 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.
Read the 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.
- Conditions
- Head and Neck Cancer, Xerostomia
- Being tested
- Self-administered acupressure, Oral health education
- Keywords
- Self-administered acupressure, Xerostomia, Head and neck cancer, Quality of life
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered acupressureBehavioural
The participants should perform self-administered acupressure 12 weeks after training
Oral health educationOther
The participants should perform general oral care by themselves after the oral health education relating to xerostomia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Oral health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks
Secondary outcomes (6)
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Shuk-Ting, The University of Hong Kong
- Investigators
- Denise Cheung, PhD, Principal investigator, School of Nursing, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465628
- Sponsor's protocol ID
- UW 24-233
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not to share IPD. All IPD for patients will be collected and analyzed confidentially, they can only be identified with their unique ID in this study. Only members in this research team have access to the personal and study data during the validity period. The PI will be responsible for safekeeping of the study data.
Publications
Davies AN. A comparison of artificial saliva and chewing gum in the management of xerostomia in patients with advanced cancer. Palliat Med. 2000 May;14(3):197-203. doi: 10.1191/026921600672294077.
PubMed 10858827Eisbruch A, Kim HM, Terrell JE, Marsh LH, Dawson LA, Ship JA. Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):695-704. doi: 10.1016/s0360-3016(01)01512-7.
PubMed 11395238Jensen SB, Pedersen AM, Vissink A, Andersen E, Brown CG, Davies AN, Dutilh J, Fulton JS, Jankovic L, Lopes NN, Mello AL, Muniz LV, Murdoch-Kinch CA, Nair RG, Napenas JJ, Nogueira-Rodrigues A, Saunders D, Stirling B, von Bultzingslowen I, Weikel DS, Elting LS, Spijkervet FK, Brennan MT; Salivary Gland Hypofunction/Xerostomia Section, Oral Care Study Group, Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO). A systematic review of salivary gland hypofunction and xerostomia induced by cancer therapies: prevalence, severity and impact on quality of life. Support Care Cancer. 2010 Aug;18(8):1039-60. doi: 10.1007/s00520-010-0827-8. Epub 2010 Mar 17.
PubMed 20237805Mercadante S, Calderone L, Villari P, Serretta R, Sapio M, Casuccio A, Fulfaro F. The use of pilocarpine in opioid-induced xerostomia. Palliat Med. 2000 Nov;14(6):529-31. doi: 10.1191/026921600701536273. No abstract available.
PubMed 11219883Garcia-Chias B, Figuero E, Castelo-Fernandez B, Cebrian-Carretero JL, Cerero-Lapiedra R. Prevalence of oral side effects of chemotherapy and its relationship with periodontal risk: a cross sectional study. Support Care Cancer. 2019 Sep;27(9):3479-3490. doi: 10.1007/s00520-019-4650-6. Epub 2019 Jan 24.
PubMed 30675665Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Nathan CO, Asarkar AA, Entezami P, Corry J, Strojan P, Poorten VV, Makitie A, Eisbruch A, Robbins KT, Smee R, St John M, Chiesa-Estomba C, Winter SC, Beitler JJ, Ferlito A. Current management of xerostomia in head and neck cancer patients. Am J Otolaryngol. 2023 Jul-Aug;44(4):103867. doi: 10.1016/j.amjoto.2023.103867. Epub 2023 Mar 28.
PubMed 36996514Dirix P, Nuyts S, Vander Poorten V, Delaere P, Van den Bogaert W. The influence of xerostomia after radiotherapy on quality of life: results of a questionnaire in head and neck cancer. Support Care Cancer. 2008 Feb;16(2):171-9. doi: 10.1007/s00520-007-0300-5. Epub 2007 Jul 6.
PubMed 17618467Bhide SA, Miah AB, Harrington KJ, Newbold KL, Nutting CM. Radiation-induced xerostomia: pathophysiology, prevention and treatment. Clin Oncol (R Coll Radiol). 2009 Dec;21(10):737-44. doi: 10.1016/j.clon.2009.09.002. Epub 2009 Oct 14.
PubMed 19833490Chambers MS, Garden AS, Kies MS, Martin JW. Radiation-induced xerostomia in patients with head and neck cancer: pathogenesis, impact on quality of life, and management. Head Neck. 2004 Sep;26(9):796-807. doi: 10.1002/hed.20045.
PubMed 15350026Walsh M, Fagan N, Davies A. Xerostomia in patients with advanced cancer: a scoping review of clinical features and complications. BMC Palliat Care. 2023 Nov 11;22(1):178. doi: 10.1186/s12904-023-01276-4.
PubMed 37950188Porter SR, Scully C, Hegarty AM. An update of the etiology and management of xerostomia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Jan;97(1):28-46. doi: 10.1016/j.tripleo.2003.07.010.
PubMed 14716254Bustillos H, Indorf A, Alwan L, Thompson J, Jung L. Xerostomia: an immunotherapy-related adverse effect in cancer patients. Support Care Cancer. 2022 Feb;30(2):1681-1687. doi: 10.1007/s00520-021-06535-9. Epub 2021 Sep 25.
PubMed 34562169Warner BM, Baer AN, Lipson EJ, Allen C, Hinrichs C, Rajan A, Pelayo E, Beach M, Gulley JL, Madan RA, Feliciano J, Grisius M, Long L, Powers A, Kleiner DE, Cappelli L, Alevizos I. Sicca Syndrome Associated with Immune Checkpoint Inhibitor Therapy. Oncologist. 2019 Sep;24(9):1259-1269. doi: 10.1634/theoncologist.2018-0823. Epub 2019 Apr 17.
PubMed 30996010Moral Nakamura D, da Graca Pinto H, Baena Elchin C, Thomazotti Berard L, Abreu Alves F, Azeredo Alves Antunes L, Pena Coto N. Efficacy of bethanechol chloride in the treatment of radiation-induced xerostomia in patients with head and neck cancer: A systematic review and meta-analysis. Radiother Oncol. 2023 Sep;186:109715. doi: 10.1016/j.radonc.2023.109715. Epub 2023 May 18.
PubMed 37207874
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-administered Acupressure for Improving Xerostomia in Head and Neck Cancer Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06465628
- Acronym / sponsor ID
- UW 24-233
- Conditions
- Head and Neck Cancer, Xerostomia
- Keywords
- Self-administered acupressure, Xerostomia, Head and neck cancer, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-administered acupressure | Experimental | Behavioral: Self-administered acupressureParticipants 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. |
| Oral health education | Active comparator | Other: Oral health educationParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered acupressureThe participants should perform self-administered acupressure 12 weeks after training | Behavioural | Self-administered acupressure |
| Oral health educationThe participants should perform general oral care by themselves after the oral health education relating to xerostomia | Other | Oral health education |
Primary outcome
Xerostomia Questionnaire
Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks
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.
6 secondary outcomes
Saliva flow
Time frame: baseline, 12 weeks and 24 weeks
Quality of life for head and neck cancer patients
Time frame: baseline, 12 weeks and 24 weeks
Symptom severity
Time frame: baseline, 12 weeks and 24 weeks
Sociodemographic characteristics
Time frame: Baseline
Acceptability
Time frame: 12 week
Acupressure Expectancy Scale
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 10858827Davies AN. A comparison of artificial saliva and chewing gum in the management of xerostomia in patients with advanced cancer. Palliat Med. 2000 May;14(3):197-203. doi: 10.1191/026921600672294077.
- Background: PubMed 11395238Eisbruch A, Kim HM, Terrell JE, Marsh LH, Dawson LA, Ship JA. Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):695-704. doi: 10.1016/s0360-3016(01)01512-7.
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- Individual participant dataSharing planned: No. We are not to share IPD. All IPD for patients will be collected and analyzed confidentially, they can only be identified with their unique ID in this study. Only members in this research team have access to the personal and study data during the validity period. The PI will be responsible for safekeeping of the study data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denise Cheung, PhD principal investigator
School of Nursing, the University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administered acupressure and Oral health education in people with Head and Neck Cancer and Xerostomia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Cheung, PhD (39176673, denisest@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerostomia Questionnaire (time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06465628, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.