The Effects of Ankaferd Hemostat on Preventing Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- ECOG Performance Score (Eastern Cooperative Oncology Group)
研究概览
简要总结
The purpose of oral care is to reduce the effect of oral pathological microbial flora and to prevent infection, pain, and bleeding associated with cancer treatment. New agents are introduced each day to be used in the prevention and treatment of mucositis in cancer treatment. One of those agents is the Ankaferd Hemostat. Ankaferd Hemostat has pleiotropic effects and anti-infective characteristics in tissue healing. The aim of this study is to evaluate the effectiveness of the Ankaferd Hemostat in the prevention of oral mucositis due to chemotherapy in adult patients diagnosed with colorectal cancer.
The study was designed as a randomized controlled experimental study to be conducted with patients who are recently diagnosed with colorectal cancer and will receive the first course of chemotherapyd. The data were collected using the Performance Score and the Oral Mucositis Evaluation Scale.
详细描述
In patients with colorectal cancer, it is important to perform symptom management dynamically as well as specific treatments for cancer. It is extremely important for healthcare professionals to know the approaches that can be recommended to patients in the management of treatment and disease-related symptoms, in order to prevent problems that may develop in patients due to the severity of symptoms. Controlling the symptoms will increase the patient's functional capacity and quality of life.
Oral mucositis is one of the common toxic effects of chemotherapy. Pain due to mucositis causes anorexia-dysphagia development and malnutrition. As a result, systemic infections can develop, dose reduction in chemotherapy courses, increase in cost and prolongation of hospital stay. Looking at the literature, chloroxidine, glutamine, palifermin was used to prevent the development of mucositis during 5-Fu-based therapy for colon cancer. Solutions such as bicarbonate were used. Although it was determined in these studies to prevent the development of oral mucositis, the incidence of mucositis is still high. Therefore, the search for new treatments and applications to prevent mucositis continues. Ankaferd Hemostat is a herbal product used as a hemostatic agent in traditional Turkish medicine. Ankaferd Hemostat affects endothelium, blood cells, angiogenesis, cellular reproduction and vascular dynamics and stimulates mediators that lead to rapidly progressive wound healing. In addition to these, the anti-inflammatory, antimicrobial, antifungal and antioxidative effects of Ankaferd Hemostat are mentioned in the literature. In order to determine the effectiveness of Ankaferd Hemostat application in chemotherapy-induced oral mucositis in adult patients, there is a single study conducted on 20 patients with mucositis grade 2-3 with hematological malignancy. While it is stated in the literature that the healing time of mucositis is the week after 7-14 days, it was seen that this decreased to 6.6 (3-10) days in the study conducted by Atay.
In another study conducted in the field of dentistry, the effectiveness of Ankaferd Hemostat in preventing the development of oroantral fistula was evaluated. In a study comparing the use of Platelet Rich Plasma (PRP) in one arm and Ankaferd Hemostat in the other arm, it was found that the antibacterial effect was more prominent in the Ankaferd Hemostat arm and the results of edema, bleeding and infection were similar in both arms .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Which patients would be assigned to the study or control group was determined with the support of a person who was independent of the study and had no knowledge of the research. This person, who had no knowledge about the research, was asked to specify a number, and in the next process, patients were assigned to the study or control group depending on whether the random number was even or odd. Study and control group patients were first evaluated in terms of inclusion criteria. The Consolidated Reporting Trials (CONSORT) diagram was used to randomize patients. The use of the consort diagram has been used to greatly improve the conduct and reporting of randomized controlled trials and to allow the study to be included in future meta-analyses.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 18-75
- •At least primary school graduate
- •No communication problems
- •No mouth sores/mucositis (Mucositis stage=0)
- •Having been diagnosed with colorectal cancer
- •To receive Folfox (5-Fluorouracil, oxalplatin, folinic acid) combination therapy as first-line therapy Not having received chemotherapy or radiotherapy with any other diagnosis before
- •Agreeing to participate in the study
- •ECOG performance status 0-2
排除标准
- •Don't be a denture
- •Having an oral herpes simplex lesion
- •Using Glutemine Research
- •Receiving G-CSF support
- •Having a physical disability that prevents them from using the right brushing technique
结局指标
主要结局
ECOG Performance Score (Eastern Cooperative Oncology Group)
时间窗: Up to Day 15
The Eastern Cooperative Oncology Group (ECOG) performance scale, also known as the WHO or Zubrod performance score, was developed in 1960. On the ECOG Performance scale, 0 means normal health and 5 means death. Low scores indicate good general condition, while high scores indicate poor prognosis. '0' Normal. Can maintain normal activity before the disease, '1' Can continue his daily life with bearable tumor findings, '2', Has disturbing tumor findings but spends more than 50% of his time out of bed, '3' Is severely disturbed and spends % of his time It is evaluated as '4' Being in a very uncomfortable condition and spending all his time tied to the bed, '5' Dead, who had to stay more than 50 of them tied to the bed.
Personal Information Form
时间窗: day 1
This form, which was created as a result of literature review by the researchers at the beginning of the study, was prepared for both the study and control group patients included in the sample. It consists of 12 questions including brushing habits and the person responsible for its care) and health status and habits (having another chronic disease, smoking and alcohol use).
Oral Care Control Chart
时间窗: Up to Day 15
This form was developed by the researchers in order to ensure that patients' oral care intervals, tooth brushing and mouthwash are made and to prevent them from being forgotten. It was used to record the oral care performed by the patients in the intervention and control groups during the follow-up period. The form is a checklist to be filled by clicking after oral care.
次要结局
- Number of participants with abnormal laboratory test results(Up to Day 15)
研究者
Yasemin Karacan
Principal investigator
Uludag University