Acupressure on Xerostomia in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

Official title:

Effect of Self-administered Acupressure for Improving Xerostomia in Head and Neck Cancer Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465628
• Other study ID #: UW 24-233
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: June 2024
• Source: The University of Hong Kong
• Contact: Denise Cheung, PhD
• Phone: 39176673
• Email: denisest[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

We hypothesize that 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.

Description:

Xerostomia is defined as "the subjective sensation of dryness of the mouth"[1, 2]. It is common in patients with acute/chronic medical conditions, especially in patients with cancer [3]. Results from observational studies reported 40% to 75% prevalence of xerostomia among cancer patients [4, 5]. Head and neck cancer patients, as the seventh most common type of cancer [6], reported an even higher prevalence (80%) of xerostomia after treatment compared with other cancer types [3, 7, 8]. 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 [9]. Besides, xerostomia may be caused or exacerbated by the concomitant or sequential use of chemotherapy agents and other drugs (e.g., opioid) [4, 10]. Consistent lacking of saliva in cancer patients can lead to increased risk of oral fungal infection, caries, swallowing problems, sleep problems, depression, fatigue [11] and altered taste [12], which may even result in poor nutritional status [13]. Furthermore, xerostomia may become a chronic and even irreversible side effect [14].

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 [15-17]. However, the evidence of pharmacological interventions (e.g., pilocarpine, bethanechol, amifostin, cevimeline and palifermin) on xerostomia is insufficient [18], and the use of pharmacotherapy may cause some common adverse effects, including nausea, sweating, nervousness, and urinary frequency [15, 16, 18-20]. 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[21], but neither with sufficient evidence of significant effect [1, 22, 23], and may also lead to adverse effects (e.g., nausea, unpleasant taste, diarrhea, and tooth mineralization)[22, 24]. 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) [25]. 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 [26]. 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 [27]. Also, acupressure/acupuncture may stimulate the parasympathetic nervous system, hence indirectly stimulate salivary glands secretion [28]. 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 [29-35], 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 [36, 37] effectively with good adherence [38]. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: March 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: 1) age =18 years; 2) able to give informed consent; 3) 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); 4) completed radiation therapy or chemoradiotherapy for at least 2 weeks; 5) complains of xerostomia after the treatment; 6) able to communicate in Cantonese or Mandarin.

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Exclusion Criteria:1) history of xerostomia prior to head and neck cancer treatment (e.g., Sjögren Syndrome); 2) practiced acupressure or received acupuncture in the last 3 months; 3) 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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Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Xerostomia

Intervention

Behavioral:
• Self-administered acupressure
The participants should perform self-administered acupressure 12 weeks after training

Other:
• Oral health education
The participants should perform general oral care by themselves after the oral health education relating to xerostomia

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (51)

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (0-10), which has been validated in several cohorts, and is regarded as the criterion standard for measuring xerostomia [2], which has been used for patients with head and neck cancer [33]. 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	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 [31, 44]. 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) [45]. The stimulated saliva will be collected in the same manner as for unstimulated saliva	baseline, 12 weeks and 24 weeks
Secondary	Quality of life for head and neck cancer patients	EORTC QLQ-HN35 will be used to measured quality of life for patients	baseline, 12 weeks and 24 weeks
Secondary	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 28 items, and the range of scores is 0-280. The scale has been validated in studies evaluating symptom severity and daily activities for head and neck cancer patients [50].	baseline, 12 weeks and 24 weeks
Secondary	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. Also, Acupressure Expectancy Scale (AES) will be administered at baseline for patients in the intervention group to evaluate the association of baseline expectations related to acupressure with clinical response. The AES consists of 4 items using a five-point scale, with higher score indicating higher expectations (score range, 0-16) [51]. The scale has been validated in studies using acupuncture on cancer patients [33].	Baseline
Secondary	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