The Effects of Ankaferd Blood Stopper (ABS)
The Effects of Ankaferd Hemostat on Preventing Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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 .
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bursa, Turkey, 16100
- Bursa Uludag University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
Don't be a denture
- Having an oral herpes simplex lesion
- Smoking
- Using Glutemine Research
- Receiving G-CSF support
- Having a physical disability that prevents them from using the right brushing technique
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Bicarbonate
1.Correct method of brush Platelet value suitable for tooth brushing Feature of toothbrush (soft, nylon bristled, rounded tip, standard size) Fluoride toothpaste, its amount and use in dry brushes In toothbrush 45 degree, the contact of the bristles with the gums, 4 times contact with the inner, outer, chewing surface, tongue cleaning The benefits of correct brushing (preventing dental plaque and gingival recession, etc.) Importance of brushing teeth twice a day (breakfast and after dinner) Preparation of mouth wash Boiled and cooled water at 100°C Putting 5 measures of boiled and cooled water in a teacup with the 20 ml measuring cup provided. Adding 1 teaspoon (6 g) of sodium bicarbonate to water Making a mouthwash Teaching how to gargle with 20 ml of bicarbonate 4 times a day at 6-hour intervals and being asked to spit it out without swallowing, |
mouth wash
Other Names:
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Experimental: Ankaferd Blood Stopper
Correct method of brush Preparation of the mouthwash Boiled and cooled water at 100°C Putting 4 ml of water in the 5 ml measuring cup given to the patient Putting Ankaferd Blood Stopper on the remaining 1 ml portion of the 5 ml beaker Giving information about making and using mouthwash Use on an empty stomach 2 hours before meals in the morning and at least 2 hours after dinner After rinsing your mouth thoroughly with a mouthwash containing 5 ml of Ankaferd Blood Stopper prepared 2 times a day, you can swallow the solution in your mouth. It is said that there is a solution-related discoloration in the mouth and teeth, but that it will return to its original state after tooth brushing. |
mouth wash
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Personal Information Form
Time Frame: day 1
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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).
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day 1
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ECOG Performance Score (Eastern Cooperative Oncology Group)
Time Frame: Up to Day 15
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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.
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Up to Day 15
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Oral Care Control Chart
Time Frame: Up to Day 15
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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.
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Up to Day 15
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of participants with abnormal laboratory test results
Time Frame: Up to Day 15
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hemoglobin, hematocrit, neutrofil, body mass index
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Up to Day 15
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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World Health Organization (WHO) Oral Mucositis Evaluation
Time Frame: Up to Day 15
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It is a grading system developed by WHO according to the clinical appearance and functional status of mucositis.
WHO evaluates oral mucositis (OM) as subjective (patient-described pain), objective (presence of erythema and ulcerations) and functional (ability to consume liquid/solid foods by mouth or inability to eat anything).
OM grade 0 (normal), grade 1 [mild focal changes (erythematous areas) no pain and tenderness yet, can be fed orally], grade 2 (painless ulcers, erythema, mild pain sensation), grade 3 (painful erythema, edema or ulcers) (depth >2 mm and less than half of the mucosa) no bleeding, can only be fed orally with liquid diet) and grade 4 (erythema, edema or ulcers (more than half the mucosa), severe pain, bleeding, no nutrition, parenteral and enteral nutrition support may be required)
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Up to Day 15
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patient education
Time Frame: Up to Day 15
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Patients were informed about the precaution of oral hygiene.
The patients were instructed to brush their teeth at least twice a day, morning and evening.
Toothbrushes with soft nylon bristles with rounded ends were given to the patients.
Modified Stillman method for tooth brushing was taught.
The bristle ends of the brush should be placed in the apical direction, against the cervical part of the teeth and partially against the adjacent gingiva (it should be activated with a back-and-forth motion at least 4 times on each tooth at an angle of 450 and simultaneously move it in the coronal direction (from bottom to top, from right to left).
announced.
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Up to Day 15
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hicran Yıldız, Hicran Yıldız
Publications and helpful links
General Publications
- Elad S. The MASCC/ISOO Mucositis Guidelines 2019 Update: introduction to the first set of articles. Support Care Cancer. 2019 Oct;27(10):3929-3931. doi: 10.1007/s00520-019-04895-x. Epub 2019 Jul 8. No abstract available.
- Djuric M, Hillier-Kolarov V, Belic A, Jankovic L. Mucositis prevention by improved dental care in acute leukemia patients. Support Care Cancer. 2006 Feb;14(2):137-46. doi: 10.1007/s00520-005-0867-7. Epub 2005 Jul 22.
- Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0.
- Goker H, Haznedaroglu IC, Ercetin S, Kirazli S, Akman U, Ozturk Y, Firat HC. Haemostatic actions of the folkloric medicinal plant extract Ankaferd Blood Stopper. J Int Med Res. 2008 Jan-Feb;36(1):163-70. doi: 10.1177/147323000803600121.
- Orhan I, Dogan R, Soylu E, Aksoy F, Veyseller B, Ozturan O, Esrefoglu M, Aydin MS. Histopathological evaluation of Ankaferd blood stopper use in the rabbit septoplasty model. Int J Pediatr Otorhinolaryngol. 2015 Mar;79(3):305-9. doi: 10.1016/j.ijporl.2014.11.015. Epub 2014 Dec 15.
- Saito H, Watanabe Y, Sato K, Ikawa H, Yoshida Y, Katakura A, Takayama S, Sato M. Effects of professional oral health care on reducing the risk of chemotherapy-induced oral mucositis. Support Care Cancer. 2014 Nov;22(11):2935-40. doi: 10.1007/s00520-014-2282-4. Epub 2014 May 23.
- Sonis ST. Mucositis as a biological process: a new hypothesis for the development of chemotherapy-induced stomatotoxicity. Oral Oncol. 1998 Jan;34(1):39-43. doi: 10.1016/s1368-8375(97)00053-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bursa Uludag University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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