Track topics on Twitter Track topics that are important to you
The purpose of this study is to evaluate the benefit of a mouthwash with a phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer.
This is a phase III, controlled, randomized, single blind study. The estimated inclusion period is approximately 24 months. The number of patients required in this monocentric study is 330 (165 per arm).
The standard treatment of oral cavity, oropharynx, hypopharynx, and cavum cancers is external radiotherapy. However, one of the associated toxicities is the occurrence of mucositis which can be a limiting factor in the treatment (dose reduction or treatment interruption can limit patient's survival), patient's quality of life decreases and severe complications can occur. The treatment of mucositis is mainly symptomatic; a randomized study has shown a benefit of a mouthwash with Benzydamine, a non steroidal anti-inflammatory drug, for patients receiving 50-Gy radiation. Another study with a lower number of patients has also shown a benefit of using a zinc sulfate solution. Boiron laboratories have developed a phytopharmaceutical preparation, Homeodent®, which has no secondary effects and which could prevent radiation-induced mucositis. This study will evaluate the efficiency of mouthwash with Homeodent® in a large randomized trial.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Homeodent®, 1.4% Sodium Bicarbonate solution
Centre Léon Bérard
Centre Leon Berard
Published on BioPortfolio: 2014-08-27T03:16:00-0400
This is a study looking at the use of sodium bicarbonate to restore the flow of blocked central line devices in patients with blood cancers. Central line devices uses thin tubes that are ...
This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the ...
This pilot phase I trial studies the safety of long-term use of sodium bicarbonate in patients with cancer. Sodium bicarbonate may neutralize tumor acidity and as a result may inhibit the ...
Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in compar...
The goal of this pilot study is to determine whether oral sodium bicarbonate can raise low serum bicarbonate concentration in people without chronic kidney disease (CKD). Participants will...
The purpose of the study is to compare the efficacy of benzydamine HCl with sodium bicarbonate in the prevention of concurrent chemoradiation-induced oral mucositis in head and neck cancer patients.
Given the known deleterious effects seen with bicarbonate supplementation for acidemia, we hypothesized that utilizing high bicarbonate concentration replacement solution in continuous venovenous hemo...
Salt sensitivity of blood pressure affects >30% of the hypertensive and >15% of the normotensive population. Variants of the electrogenic sodium bicarbonate cotransporter NBCe2 gene, SLC4A5, are assoc...
This study evaluated and compared plaque removal efficacy of commercially available dentifrices containing sodium bicarbonate (NaHCO3) to those without NaHCO3 in a single timed brushing clinical study...
The objective of this study was to determine of oral and oropharynx cancer mortality rate and the results were analyzed by applying the Spatial Analysis of Empirical Bayesian Model. To this end, we us...
Bicarbonate transporters that move BICARBONATE IONS in exchange of CHLORIDE IONS or SODIUM IONS across membranes. They regulate acid-base HOMEOSTASIS, cell volume and intracellular pH. Members include CHLORIDE-BICARBONATE ANTIPORTERS (SLC4A1, 2, 3, and 9); SODIUM-COUPLED BICARBONATE TRANSPORTERS (SLC4A4 and 5, 7, 8 and 10); and a sodium borate cotransporter (SLC4A11 protein).
Proteins that cotransport sodium ions and bicarbonate ions across cellular membranes.
Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).
Membrane proteins that allow the exchange of chloride ions for bicarbonate ions across the cellular membrane. The action of specific antiporters in this class serve important functions such as allowing the efficient exchange of bicarbonate across red blood cell membranes as they passage through capillaries and the reabsorption of bicarbonate ions by the kidney.
Tumors or cancer of the OROPHARYNX.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Dentistry is the study, management and treatment of diseases and conditions affecting the mouth, jaw, teeth and their supporting tissues (Oxford Medical Dictionary) The work of a dentist ranges from regular patient check-up to orthodontics and surgery....
Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers) - Mouth cancer can develop on the lip, the tongue, the floor...