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Xerostomia clinical trials

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NCT ID: NCT04392622 Recruiting - Xerostomia Clinical Trials

d-Limonene +Radiation +Platinum Based Chemo for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma

Start date: February 15, 2021
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT04222478 Recruiting - Xerostomia Clinical Trials

Interest of Auriculotherapy in the Treatment of Xerostomia

AURICULOXERO
Start date: December 4, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia

NCT ID: NCT04184908 Recruiting - XEROSTOMIA Clinical Trials

Clinical Study New Gel for Xerostomia

XEROSTOMIA
Start date: October 1, 2019
Phase: Phase 1
Study type: Interventional

At present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. Current therapy for the control of xerostomia is based on the following measures: 1. General measures ; review and control of drugs,hydration and dietary advice: The main recommendations are found in the following scheme. 2. Saliva stimulants( Topics and sistemic )The option of using chewing stimuli by chewing gum with non-cariogenic sweeteners helps to improve symptoms. The investigators can also use gustatory stimuli, such as citric acid that is a potent stimulator of salivary secretion. Among the most commonly used pharmacological agents are: pilocarpine, bethanecol, civemiline 3. Saliva substitutes or artificial saliva. Saliva substitutes can provide a moisture retention layer in the oral mucosa and can be administered by liquids, spray, pills or gels. Topical treatments have few adverse effects and improve the quality of life of patients with xerostomia; In addition, they maintain oral health.

NCT ID: NCT03972072 Recruiting - Clinical trials for Head and Neck Cancer

MRI - Guided Adaptive RadioTHerapy for Reducing XerostomiA in Head and Neck Cancer (MARTHA-trial)

MARTHA
Start date: October 15, 2019
Phase: N/A
Study type: Interventional

Radiotherapy is the main treatment for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Many advances regarding tumor control and patient survival have been made over the past decades. However, treatment-induced toxicity remains a crucial problem, leading to reduced quality of life and permanent impairment for many survivors. Xerostomia is up to this day the leading cause of late toxicity for these patients. Toxicity has been reduced by implementation of modern image guided radiotherapy (IGRT) and intensity-modulated radiotherapy (IMRT), but the low soft-tissue contrast of routine x-ray image guidance does not allow exact planning adaptation and daily imaging is associated with high radiation exposure. Furthermore, despite the routinely use of IMRT, rates of clinically relevant xerostomia (i.e. grade 2 or worse) are still common and reported in approximately 38%. Recently developed hybrid machines (MRidian®-CE approval since 2016), consisting of a linear accelerator and an integrated low-field MRI, could allow a) better visualization of tumor and organs at risk, such as parotid glands during patient positioning and daily treatment, b) daily imaging without additional radiation exposure, c) narrowest established safety margins for the treatment volumes, and finally d) repetitive adaptation of target volumes according to changes in patient weight and tumor anatomy during the radiotherapy course. These procedures would facilitate a high-precision treatment and help reduce dose exposure of critical structures.

NCT ID: NCT03632096 Recruiting - Xerostomia Clinical Trials

Photobiomodulation in Salivary Production of Patients With Xerostomy

Start date: September 10, 2018
Phase: Phase 2
Study type: Interventional

Xerostomia is a quantitative and qualitative alteration of saliva, a symptom present in individuals who make continuous use of medications to control chronic diseases, including hypertension. Difficulties in mastication, swallowing, phonation and palate are present, besides oral burning syndrome, periodontal disease, root caries and bad breath that will interfere in the quality of life, making it difficult to socialize in society. Currently, the methods presented for treatment of xerostomia are palliative, so their use does not consist of an effective treatment. The objective of this study is to evaluate the efficacy of photobiomodulation in the production of saliva in patients with xerostomia induced by antihypertensive drugs. The method consists in the application of the low intensity laser in the three pairs of salivary glands - parotid, submandibular and sublingual. The parameters that will be used are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2. The control group will have a simulation of the application of the laser, with the device turned off. Because it is an infrared light, it is invisible and this will not induce the patient to notice that the device is turned off. In the group that receives the photobiomodulation the device will have its timer turned off, to avoid the perception of sound difference. At the end of the sessions, a sample of saliva will be collected, which will be compared to the initial sample.

NCT ID: NCT03400969 Recruiting - Xerostomia Clinical Trials

Effectiveness of Three Different Oral Moisturizers in Palliative Care Patients.

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

This study compares the effectiveness of 3 different oral moisturizers; 17% watery solution of glycerol, OGT oral spray, Aequasyal, and a newly developed Product, Salient.

NCT ID: NCT03295019 Recruiting - Sleep Apnea Clinical Trials

"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients

Start date: August 4, 2017
Phase: N/A
Study type: Interventional

During routine clinical practice, it is observed that patients with suspected obstructive sleep apnea (OSA) often reported waking up with a dry mouth during the night or in the morning. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of a proprietary formulation in comforting dry mouth in Sleep Apnea patients.

NCT ID: NCT02982577 Recruiting - Xerostomia Clinical Trials

Effect of Pilocarpine in Patients With Xerostomia

Start date: April 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of a spray the basis of pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary Sjögren's Syndrome treated at the Clinics Hospital of Faculty of Medicine of Ribeirão Preto (HCFMRP-USP), and its impact on quality of life.

NCT ID: NCT02705937 Recruiting - Xerostomia Clinical Trials

Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.

LactoXeros
Start date: September 13, 2017
Phase: N/A
Study type: Interventional

Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva substitutes are disappointing (bad taste, poor efficiency). The hypothesis stems from the "empirical" observations that many patients alleviate dry mouth symptoms by the consumption of dairy products. Through its composition, the dairy product in itself provides relief for the patient, due both to its physical and biochemical properties, which could explain these observed improvements, and to elements related to the phenomena of consumption of food as an alternative to medication. In the latter case, hedonism takes on a role which has not been previously assessed. Initial work undertaken with the department of applied research at the National Dairy Industry School (ENIL) led to the prototyping of a new milk product, to qualify and adapt a product with a "health benefit" in patients suffering from xerostomia. This dairy product has specific taste, texture and lubrication properties and will be tested in a randomized controlled cross-over study for its efficiency and acceptability versus a reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at Dijon and at Besançon University Hospitals. This way of combatting xerostomia at the interface of patients' diet, such as it is proposed here, could help improve their quality of life, minimize harmful effects (infection, decay) and promote adherence to treatments which are responsible for xerostomia.

NCT ID: NCT02066896 Recruiting - XEROSTOMIA Clinical Trials

Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome

Start date: May 2014
Phase: Phase 3
Study type: Interventional

This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.