Xerostomia

13

Review clinical trials related to Xerostomia. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Evaluating the Optimal Timing of Acupuncture for Managing Chemoradiation-induced Xerostomia in Patients With Head and Neck Cancers

While existing data supports the use of acupuncture to reduce radiation-induced xerostomia, the optimal timing of acupuncture for managing chemoradiation-induced xerostomia remains an area of active investigation. Prior studies have administered acupuncture either in patients who developed xerostomia 12 months after radiation 10 or during the radiation therapy itself 9. The hypothesis is that acupuncture may be more effective in preventing and reducing xerostomia when administered early during CRT, rather than after chronic xerostomia has already set in. Yet, oncologists have concerns about the potentially higher risk of complications, such as infection, associated with acupuncture, especially if administered concurrently with chemoradiotherapy. Therefore, this study aims to conduct this randomised trial to evaluate the impact of early versus delayed acupuncture on patient-reported and objective measures of xerostomia, as well as the safety and tolerability of acupuncture in this setting. To our knowledge, this will be the first randomised clinical trial evaluating the optimal timing for incorporating acupuncture to reduce xerostomia in patients undergoing chemoradiation for head and neck cancers. It is also the first study conducted in Singapore to study the role of acupuncture in reducing CRT-induced xerostomia.

Participants needed: 50
Trial details
Age: 21+Biological sex: AllType: InterventionalSponsor: National University Hospital, SingaporeUpdated: Jun 29, 2026Locations: 1
Eligibility criteria

Aged 21 years or older [+6]

History of xerostomia, Sjögren's disease, or another underlying systemic illness... [+10]

Status: Recruiting

Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia

The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth. Participants will: * have bone marrow collected using a needle * undergo a salivary gland ultrasound * complete questionnaires * receive an injection of the bone marrow cells into a salivary gland

Participants needed: 36
Trial details
Phase: Phase 1Age: 18-90Biological sex: AllType: InterventionalSponsor: University of Wisconsin, MadisonUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

Xerostomia, defined as an unstimulated salivary flow <1.2 mL in 5 minutes docume... [+12]

Patients with one submandibular gland [+12]

Status: Recruiting

Effect of Enzymatic-Containing Mouth Spray (Oral7®) on Xerostomia Symptoms, Salivary Flow Rate, and Oral Health-Related Quality of Life in Older Patients

Background: Xerostomia, or dry mouth, is a prevalent condition among older adults and has significant implications for oral and systemic health. It is associated with impaired chewing, swallowing, and speech, and increases the risk of oral infections, dental caries, and gum disease. Xerostomia may also contribute to malnutrition and aspiration pneumonia. Objective: This study aims to evaluate the effectiveness of an enzymatic-containing mouth spray (Oral7®) on xerostomia symptoms, unstimulated salivary flow rate, and oral health-related quality of life (OHRQoL) in older patients with xerostomia. Methods: A single-center, randomized, double-blind, placebo-controlled trial will be conducted at Hospital Universiti Sains Malaysia from August 2025 to July 2026. Eligible participants aged 60 and above with self-reported xerostomia will be randomly assigned to receive either Oral7® Mouth Spray or a placebo spray for four weeks. The primary outcome is the mean change in Summated Xerostomia Inventory (SXI) scores between groups from baseline to post-intervention. Secondary outcomes include changes in unstimulated salivary flow rate using the sialometry technique and OHRQoL measured by the Geriatric Oral Health Assessment Index (GOHAI) at baseline and three months post-intervention. Data will be analyzed using SPSS version 29. Conclusion: This trial will provide evidence on the efficacy of Oral7® Mouth Spray in alleviating xerostomia symptoms and improving salivary function and oral health-related quality of life in older adults, potentially guiding future clinical management of this condition.

Participants needed: 100
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: ZAINAB MAT YUDINUpdated: May 22, 2026Locations: 1
Eligibility criteria

Aged 60 years and above [+4]

• Patients on salivary substitutes for the past one week [+3]

Status: Recruiting

Does Hyaluronic Acid Help Relieve Dry Mouth?

The goal of this clinical trial is to learn if hyaluronic acid infiltration helps relieve dry mouth symptoms in adults with xerostomia. It will also assess the safety and duration of the treatment's effects. The main questions it aims to answer are: 1. Does hyaluronic acid improve the sensation of dry mouth? 2. What side effects may occur after treatment? 3. How long does the effect of the treatment last? 4. Are there changes in salivary flow and pH after treatment? Researchers will compare hyaluronic acid to a placebo (a look-alike substance with no active ingredient) to determine its effectiveness. Participants will: Receive submucosal injection of either hyaluronic acid or placebo Visit the clinic once a month for 6 months for follow-up evaluations Not be required to perform any tasks at home

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of BarcelonaUpdated: May 18, 2026Locations: 1
Eligibility criteria

Patients over 18 years of age [+2]

Underage patients [+10]

Status: Recruiting

Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study

The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Universidad de GranadaUpdated: Jan 5, 2026Locations: 1
Eligibility criteria

men or women aged 18 years or older and were diagnosed with HNC. [+8]

patients with metastases. [+4]

Status: Recruiting

d-Limonene +Radiation +PlatinumBasedChemo for Xerostomia Prevention in LocallyAdvanced HNSCC

This study explores the safety of d-limonene, a commercially-available dietary supplement (food) as a potential therapeutic for the severe dry mouth (xerostomia) experienced by patients with head and neck cancer as a side effect of their anti-cancer treatment.

Participants needed: 40
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Stanford UniversityUpdated: Jul 20, 2025Locations: 1
Eligibility criteria

Histologically or cytologically confirmed diagnosis of advanced loco regional sq... [+9]

History of allergic reactions attributed to citrus fruits [+1]

Status: Recruiting

Acupressure on Xerostomia in Head and Neck Cancer Patients

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.

Participants needed: 126
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: The University of Hong KongUpdated: May 28, 2025Locations: 1
Eligibility criteria

age ≥18 years; [+5]

history of xerostomia prior to head and neck cancer treatment (e.g., Sjögren Syn... [+2]

Status: Not yet recruiting

Efficacy of the Vacucis Candida® Autovaccine

Introduction: Oral candidiasis is an infectious disease caused by the growth of Candida colonies and their penetration into oral tissues when physical barriers and host defenses are weakened. It constitutes one of the most common pathologies within the field covered by Dentistry. Candida infections are found in at least 80% of AIDS patients and in a third of HIV infection cases. Systemic diseases such as diabetes and a wide pharmacological arsenal to which the general population is subjected, are other causes of the increase in the prevalence of this disease. In addition, the high prevalence of oral sequelae (hyposialia) in the population over 65 years of age, due to the specific characteristics of this age group, such as multiple pathologies and drug use, explains the presence of this disease in this segment. of the population One of the great difficulties for the study of this disease is the diversity of predisposing factors, which do nothing but throw greater confusion into the results of the different works. Objective: To evaluate the reduction/suppression of signs and symptoms of oral candidiasis in patients treated with head and neck RT, users of Vacucis or Placebo. Material and method: Patients will receive information regarding the trial and, if they meet the inclusion criteria and agree to participate in it, they will sign the informed consent. All patients will be informed following the usual care practice of the characteristics of their candidiasis infection as well as the possibilities and alternatives of treatment and their respective efficacy. A descriptive analysis of the sample in terms of prevalence will be carried out. Categorical variables will be described as frequency and percentage and continuous variables as mean and standard deviation or median and interquartile range depending on their adjustment to normality, which will be calculated with the Kolmogorov-Smirnov test. To study the effect of the vaccine on the evolution of candidiasis, the Chi-square test, Student's t test or the non-parametric Mann-Whitney test will be used. The association of prevalence with CFU in both groups will be analyzed using the ANOVA test. Those values of p \< 0.05 will be considered significant.

Participants needed: 46
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Santiago de CompostelaUpdated: Oct 17, 2024Locations: 1
Eligibility criteria

Patients with a history of RT in the head and neck region that directly or indir... [+4]

Minor patients [+11]

Status: Recruiting

An Investigation Into Taste Problems Associated With Xerostomia in Patients With Advanced Cancer

Taste problems and xerostomia (dry mouth) are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. This study will explore the relationship between dry mouth and taste problems in patients with advanced cancer.

Participants needed: 120
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Our Lady's Hospice and Care ServicesUpdated: Sep 19, 2024Locations: 1
Eligibility criteria

18 years of age [+5]

Cognitive impairment (unable to provide consent / complete questionnaire) [+6]

Status: Not yet recruiting

Diagnostic Interest of the Buccal Schirmer Test in Xerostomia During Sjögren's Syndrome: XERODIAG

Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Its diagnosis mainly relies on the measurement of salivary flow (SF). Performing this test is unpleasant for the patient, lacks precision, can be influenced by certain conditions, and requires good patient cooperation. Other alternatives such as the buccal Schirmer test can be used. The aim of this study is to demonstrate the non-inferiority of the buccal Schirmer test compared to SF measurement. This is a diagnostic study comparing a group of patients (n=90) with Sjogren's syndrome (SS) and normal SF (≥0.1 ml/minute) to a group of patients with SS and decreased SF (\<0.1 ml/minute).

Participants needed: 180
Trial details
Age: 18-100Biological sex: AllType: ObservationalSponsor: University Tunis El ManarUpdated: Aug 2, 2024
Eligibility criteria

age over 18 years [+1]

Cognitive or dementia disorders [+1]

Status: Not yet recruiting

Artificial Saliva Containing Cumin and Ginger Extract in Hemodialysis Patients With Xerostomia

Hemodialysis patients with xerostomia are divided into 2 groups which are group A (start with artificial saliva containing cumin and ginger extract for 2 weeks, free periods 2 weeks, then placebo for 2 weeks) and group B (start with placebo for 2 weeks, free periods 2 weeks, then artificial saliva containing cumin and ginger extract for 2 weeks). Amount of saliva (g/min), xerostomia's questionnaire, Increase of saliva score, World Health Organization Oral Mucositis Grading Scale, acid and base of saliva, quality of life's questionnaire will measure before, after using the sample for 7 and 14 days.

Participants needed: 26
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Chulalongkorn UniversityUpdated: Jul 1, 2024
Eligibility criteria

Age more than 18 years [+3]

Patients with sialolith or Sjogren's syndrome [+6]

Status: Not yet recruiting

Artificial Saliva Containing Cumin and Ginger Extract in Head and Neck Cancer Patients With Xerostomia

The objectives of this study are to evaluate efficacy and safety of artificial saliva containing cumin and ginger extract in head and neck cancer patients with xerostomia.

Participants needed: 52
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Chulalongkorn UniversityUpdated: Jun 24, 2024
Eligibility criteria

Age more than 18 years [+3]

Sialolith or Sjogren's syndrome [+6]

Status: Not yet recruiting

Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia

The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14).

Participants needed: 18
Trial details
Phase: Phase 1, Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Assistance Publique Hopitaux De MarseilleUpdated: Nov 18, 2023
Eligibility criteria

Patients from 18 to 65 years. [+5]

Medical history of head and neck neoplasia [+13]