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Xerostomia clinical trials

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NCT ID: NCT05885906 Active, not recruiting - Xerostomia Clinical Trials

Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics

Start date: July 24, 2023
Phase: Phase 3
Study type: Interventional

The objectives of the present study are to: 1. Compare the clinical efficacy of (50%) aloe vera versus (20%) thyme honey mouthwash on management of xerostomia in diabetic patients by measuring the salivary flow rate as a primary objective. 2. Asses the biochemical effect of aloe vera and thyme honey on the level of salivary nitric oxide, xerostomia grade as well as patient quality of life as a secondary objective. Research question: Which is better aloe vera or thyme honey in improving salivary flow rate in diabetic patients suffering from xerostomia? Patient Grouping and Randomization: Patients with xerostomia will be randomly distributed into three groups using a computer-generated randomization table. Allocation concealment will be achieved by a sealed opaque envelope with a ratio of 1:1:1 Group 1 (Aloe Vera group) Include (15) patient suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash Group 2 (Thyme honey group): Include (15) patient suffering from diabetes induced xerostomia that will receive thyme honey mouthwash Group 3 (Saline control group): Include (15) patient suffering from diabetes induced xerostomia that will receive saline mouthwash

NCT ID: NCT05882890 Active, not recruiting - Clinical trials for Xerostomia Following Radiotherapy

Does Craniosacraltherapy Have an Effect on Xerostomia and Other Late Sequelae on People Who Has Been Suffering From Cancer in Mouth and Throat?

Start date: March 18, 2022
Phase: N/A
Study type: Interventional

The current study aims to assess the efficacy of manual treatment with craniosacral therapy of fascial tissue in throat, neck, cranial and mouth region, on radiation and/ore surgery induced salivary gland hypofunction and xerostomia in patients who have been through surgery and/or radiation therapy because of cancer in to the troat and mouth regions. The hypothesis of this project is based on a recent clinical case treated by me: I practice as a physiotherapist and craniosacral therapist in a private clinic. The patient in question was treated with craniosacal techniques( techniques that mobilizes the fascia, ment very broad - meninges, dura,sleeves around the nerve-tissue). He suffered from xerostomia and hyposaliva after neck surgery and radiation therapy four years prior to my treatment. During the second treatment of fascial release of the scar tissue and of the tissue around atlas, axis and occiput the patient strongly felt that his saliva started flowing. He received an additional 3 treatments, with fascial release techniques in neck, throat meninges and mouth regions, and three months after his last treatment the patient still reported much better production of saliva than before start of treatment. Furthermore, the patient reported significant gains in ease of speaking and eating. This project aim to assess if this was only an isolated event or if craniosacral therapy could be an evidence based method aiming to increase saliva production and decrease xerostomia for patients after surgical and radiation therapy.

NCT ID: NCT05060341 Active, not recruiting - Clinical trials for Radiation-induced Xerostomia

Long-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia

Start date: November 12, 2020
Phase:
Study type: Observational

This study is a long-term follow-up study for patients who have been administered AAV2hAQP1 in the Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity in Subjects with Radiation Induced Parotid Gland Hypofunction and Xerostomia

NCT ID: NCT04776538 Active, not recruiting - Clinical trials for Xerostomia Following Radiotherapy

Safety and Efficacy of Mesenchymal Stem Cell for Radiation-induced Hyposalivation and Xerostomia in Previous Head and Neck Cancer Patients

MESRIX-III
Start date: February 9, 2021
Phase: Phase 2
Study type: Interventional

The incidence of head and neck cancer is increasing in the Western World, including Denmark. Cancer of the head and neck and its treatment often have a detrimental and lifelong impact on the quality of life of the patients. Radiotherapy is a key component for approximately 80% of all patients with head and neck cancer and despite the enormous improvement in ionizing radiotherapy, the radiation still leads to significant ionizing of healthy tissue, including the radiation-sensitive salivary glands. Salivary glands suffer severe damage from radiation, and as these cells are the principal sites of fluid secretion one of the most prevalent side effect of irradiation for head and neck cancer is hyposalivation and dry mouth syndrome, xerostomia. Xerostomia leads to debilitating oral disorders and major implication for the overall quality of life, including social life and professional life. Currently, only symptomatic treatment is available to patients suffering from xerostomia, and therefore there is an immense, unmet need for new treatment strategies for hyposalivation and xerostomia. Stem cells have been identified as a potential treatment modality for a wide variety of disorders by their ability to differentiate into many functional cell types, and stem cells have been suggested as an approach to restoring the function of salivary glands after radiotherapy damage. The purpose of the study is to assess the efficacy and safety of the injection of stem cells from healthy donors on radiation-induced salivary gland hypofunction and xerostomia in previous head and neck cancer patients. The project can potentially help to develop a clinically relevant treatment option for the growing number of patients suffering from xerostomia after irradiation. The development of new therapies is especially meaningful since only sub-optimal, symptomatic treatments are currently available, and since the symptom of xerostomia immensely reduces quality of life.

NCT ID: NCT04657913 Active, not recruiting - Xerostomia Clinical Trials

Mouth Dryness and Thirst of Patients Undergone Major Abdominal Surgery

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of spray use on dry mouth and thirst of patients who had undergone major abdominal surgery. The methods used to alleviate the thirst and dry mouth experienced by patients undergoing major abdominal surgery are limited. This research was conducted as a randomized controlled trial.

NCT ID: NCT03874572 Active, not recruiting - Xerostomia Clinical Trials

Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth

MESRIX-SAFETY
Start date: March 18, 2019
Phase: Phase 1
Study type: Interventional

An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma

NCT ID: NCT03176368 Active, not recruiting - Xerostomia Clinical Trials

Coconut Oil: Managing Radiation-Induced Xerostomia

Start date: October 5, 2017
Phase: N/A
Study type: Interventional

This study will seek to assess the experience of using of coconut oil as an approach to managing radiation-induced xerostomia in patients previously treated for cancer in the head and neck. There is a high prevalence of radiation-induced xerostomia in this patient population, and the condition has significant negative impact on patients' quality of life. There is currently no agreed-upon standard of care for the treatment of this condition. Anecdotal evidence from patients and both physicians and allied healthcare providers suggests improvement in this condition with the use of coconut oil, but this has not previously been formally studied. We therefore propose a case series study to formally assess the tolerability and efficacy of coconut oil as an approach to managing radiation-induced xerostomia.

NCT ID: NCT02446249 Active, not recruiting - Clinical trials for Squamous Cell Head and Neck Cancer

Safety of a Single Administration of AAV2hAQP1, an Adeno-Associated Viral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in People With Irradiation-Induced Parotid Salivary Hypofunction

Start date: May 4, 2015
Phase: Phase 1
Study type: Interventional

Background: - Radiation can cause the parotid salivary glands to make less saliva (dry mouth). This can cause problems like infections and tooth decay. Researchers hope a new drug can help people with dry mouth caused by radiation. Objectives: - To examine the safety of AAV2hAQP1 gene therapy. To see if the drug increases saliva in people whose parotid glands have had radiation. Eligibility: - People at least 18 years of age with a history of radiation therapy for head and neck cancer. Design: Participants will be screened in 2 visits with: - medical history - physical exam - scans of the head, neck, and chest - intravenous administration of glycopyrrolate to stop saliva - saliva collections - sialogram which is a procedure in which a substance is injected in the parotid gland and X-rays are taken. - non-drug infusion - a small piece of skin being taken 3-5-day hospital stay: Participants will receive the gene infusion. The AAV2hAQP1 will be in a solution in a syringe. It will be slowly pushed into the parotid gland through the parotid duct, an opening in the mouth near the second upper molar tooth. 10 outpatient visits over 3 years. These may include: - repeats of selected screening tests, including saliva collection - blood and urine tests - oral and dental examinations - head and neck exams, including the use of a thin scope to see the back of the throat - questionnaires - a small piece of parotid tissue being taken by either a small scope through the parotid duct or by a small needle guided by ultrasound - scans of the head and neck. For some, contrast will be injected in a vein - completion of a diary about how the participant feels between visits - swabs of teeth and gums to assess the microbiome of the mouth

NCT ID: NCT02057510 Active, not recruiting - Clinical trials for Head and Neck Cancer

Observational Study of Dental Outcomes in Head and Neck Cancer Patients

ORARAD
Start date: February 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. The study will also evaluate the sequelae of radiation therapy and oral complications that may occur as a result to receiving radiation therapy.

NCT ID: NCT01266044 Active, not recruiting - Clinical trials for Head And Neck Cancer

Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

Start date: December 9, 2011
Phase: Phase 3
Study type: Interventional

The goal of this clinical research study is to learn if acupuncture can help to prevent xerostomia (dry mouth) and improve the quality of life in patients who receive radiation treatment to the head and neck. This study will determine if one acupuncture treatment approach is more effective than another. Dry mouth is a common problem among cancer patients who have received radiation treatment to the head and neck.