Trial Title:
Acupressure on Xerostomia in Head and Neck Cancer Patients
NCT ID:
NCT06465628
Condition:
Head and Neck Cancer
Xerostomia
Conditions: Official terms:
Head and Neck Neoplasms
Xerostomia
Conditions: Keywords:
Self-administered acupressure
Xerostomia
Head and neck cancer
Quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Self-administered acupressure
Description:
The participants should perform self-administered acupressure 12 weeks after training
Arm group label:
Self-administered acupressure
Intervention type:
Other
Intervention name:
Oral health education
Description:
The participants should perform general oral care by themselves after the oral health
education relating to xerostomia
Arm group label:
Oral health education
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.
Criteria for 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.
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Queen Mary Hospital
Address:
City:
Hong Kong
Zip:
000000
Country:
Hong Kong
Contact:
Last name:
Denise Cheung, Dr.
Phone:
852-39176673
Email:
denisest@hku.hk
Start date:
June 15, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465628
