Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465628
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-13
Brief Title:
Acupressure on Xerostomia in Head and Neck Cancer Patients
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Effect of Self-administered Acupressure for Improving Xerostomia in Head and Neck Cancer Patients a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 acutechronic 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 eg 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 eg 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 eg citric and malic acids chewing gum toothpaste and lozenges and saliva substitute eg 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 eg 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 acupressureacupuncture 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 eg 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 eg 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 eg 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 eg citric and malic acids chewing gum toothpaste and lozenges and saliva substitute eg 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 eg 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 acupressureacupuncture 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None