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Xerostomia clinical trials

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NCT ID: NCT06465628 Not yet recruiting - Clinical trials for Head and Neck Cancer

Acupressure on Xerostomia in Head and Neck Cancer Patients

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06412627 Not yet recruiting - Dry Mouth Clinical Trials

The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube

Start date: May 2024
Phase: N/A
Study type: Interventional

This is an experimental study aimed at exploring the effectiveness of using 4°C frozen gauze with normal saline for relieving dry mouth and thirst in patients with endotracheal tubes.

NCT ID: NCT06392711 Not yet recruiting - Xerostomia Clinical Trials

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

Start date: June 2024
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT06313905 Not yet recruiting - Sjogren's Syndrome Clinical Trials

EVADRY® in the Treatment of Xerostomia in Sjögren's Syndrome

DRYLESS
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Symptomatic therapeutic alternatives for this syndrome are limited in Tunisia. We resort to bromhexine off-label with low efficacy. The aim of this work is to demonstrate the superiority of a treatment based on dietary supplements (EVADRY) vs placebo in the treatment of xerostomia. This is a double-blind randomized clinical trial with 2 arms: an EVADRY arm (n=90) and a placebo arm (n=90). The primary outcome measure is a 35% increase in salivary flow after 3 months. Secondary outcome measures were based on the Oral Health Impact Profile questionnaire, Xerostomia Inventory, the HAD depression scale, and the buccal Schirmer test.

NCT ID: NCT06276946 Not yet recruiting - Clinical trials for Head and Neck Cancer

Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia

Start date: August 8, 2024
Phase: N/A
Study type: Interventional

Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment. This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering.

NCT ID: NCT06201923 Not yet recruiting - Xerostomia Clinical Trials

The Efficacy of Thyme Honey Mouth Rinse on Polypharmacy-induced Xerostomia

Start date: January 2024
Phase: Phase 4
Study type: Interventional

The study is designed to evaluate the clinical efficacy of thyme honey as a mouth rinse in the management of polypharmacy-induced xerostomia concerning the unstimulated whole salivary flow rate and quality of life of patients along with a biochemical assessment of salivary nitric oxide levels.

NCT ID: NCT06012604 Not yet recruiting - Clinical trials for Xerostomia Following Radiotherapy

Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells

Start date: September 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about toxicity of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) treatment in head and neck cancer patients with for post-radiation xerostomia. The main question it aims to answer is the toxicity of intervention and the secondary objective is to assess preliminary efficacy. Participants will receive MSC in both parotid and submandibular glands: the toxicity of the intervention will be assessed using CTCAE v5.0 and its effect will be evaluated through measuring salivary flow and composition, radiologically (ultrasonography, magnetic resonance imaging), with scintigraphy and questionnaires. In the control group, salivary gland function (salivary flow and saliva composition) will be assessed for comparison with the intervention group.

NCT ID: NCT05872464 Not yet recruiting - Xerostomia Clinical Trials

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

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05857358 Not yet recruiting - Xerostomia Clinical Trials

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

XEROCELL
Start date: January 2024
Phase: Phase 1/Phase 2
Study type: Interventional

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).

NCT ID: NCT05506137 Not yet recruiting - Xerostomia Clinical Trials

Xerostomia in Patients With a Life-limiting Condition or Frailty

Start date: January 2023
Phase: Phase 3
Study type: Interventional

Xerostomia, the subjective feeling of dry mouth, is a common symptom during the last year of life in patients with a life-limiting condition or frailty. Xerostomia leads to functional alterations (such as burning sensations, an altered taste perception, and difficulties with chewing, swallowing, and speaking), has disabling social consequences and significantly downgrades the perceived quality of life. It is an under-exposed and under-treated symptom often caused by alterations in the quality and quantity of saliva. Locally administered pilocarpine could be a promising drug in this regard as it alleviates xerostomia by increasing the production of saliva.