Effects of Mechanical and Electrical Sialogogues in Stimulation of the Flow and Biochemical Composition of Saliva in Patients Transplanted With Hematopoietic Stem Cells
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Salivary flux
研究概览
简要总结
The transplantation of hematopoietic stem cells (THSC) is a therapeutic modality developed for the treatment of various diseases such as leukemia, bone marrow aplasia, lymphomas, multiple myeloma, among others. Most patients who undergo the THSC usually have oral manifestations as a result of immunosuppression achieved by chemotherapy and/or radiotherapy. The most common complications are the reduction of salivary flow, mucositis and graft-versus-host disease (GVHD). These conditions can be very debilitating and interfere with medical therapy, leading to systemic complications, affecting the prognosis and increasing the length of hospitalization of the patient and the costs of treatment. To date, there is no protocol that prevents the reduction of salivary flow and minimizes the occurrence of mucositis and GVHD in these patients. This study aims to verify the effectiveness of treatment with two sialogogues (Hyperboloid and TENS [transcutaneous electrical stimulation]) to restore the flow and biochemical composition of saliva in patients undergoing THSC myeloablative and non-myeloablative conditionating regime.
详细描述
It will be included in the sample a total of 60 patients undergoing hematopoietic stem cell transplantation (THSC) at the Clinical Hospital. Patients will be randomly divided into four groups, each with 15 subjects: group I patients who will use only the mechanical sialogogue; group II patients who will make use of electrical sialogogue (TENS); group III patients who will make use of mechanical sialogogue associated with TENS and group IV patients who will not receive therapy (control).
The project will present the following experimental design:
- Selection of patients to be subjected to the transplantation of hematopoietic stem cells;
- Implementation of a reference sialometry;
- Institution of therapy with mechanical and electrical sialogogue;
- Clinical examination, assessment of the occurrence of mucositis and obtention of saliva samples pre- and post-THSC;
- Qualitative analysis of saliva (turbidity, viscosity and color);
- Biochemical analysis of saliva;
- Statistical analysis of data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients submitted to THSC at Clinical Hospital of Federal University who underwent a myeloablative or a non-myeloablative conditioning regime
- •Age over 16 years
- •Oral mucosa intact on the first day of conditioning
- •Ability to cooperate with treatment
排除标准
- •Cases with no clinical follow up
- •Patients who refuse to participate
- •Patients with no ability to cooperate with treatment
研究组 & 干预措施
Elastomers
Patients will use hyperboloid as mechanical salivary stimuli. Patients will chew hyperboloid 3 times a day
干预措施: mechanical stimulation (Elastomers) (Device)
TENS
TENS is a eletric stimuli that will be use in the skin near to parotid glands. Patients will receive TENS treatment as eletric salivary stimuli. Patients will receive TENS stimuli once a day for 15 days
干预措施: TENS (Procedure)
Elastomers+TENS
Patients will receive TENS plus hyperboloid as eletric and mechanical treatment for salivary stimuli
干预措施: mechanical stimulation (Elastomers) (Device)
Elastomers+TENS
Patients will receive TENS plus hyperboloid as eletric and mechanical treatment for salivary stimuli
干预措施: TENS (Procedure)
No therapy (control)
Patients will not receive intervention
结局指标
主要结局
Salivary flux
时间窗: 7 days
次要结局
未报告次要终点
研究者
Tarcilia Aparecida da Silva
Associate Professor
Federal University of Minas Gerais