The Effects of Ankaferd Blood Stopper

Colon Cancer Clinical Trial

— ABS  

Official title:

The Effects of Ankaferd Hemostat on Preventing Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05438771
• Other study ID #: Bursa Uludag University
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 2, 2023

Study information

• Verified date: May 2023
• Source: Bursa Uludag Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 .

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 66
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Colon Cancer
• Mucositis
• Nurse's Role
• Oral Mucositis
• Stomatitis

Intervention

Combination Product:
• Ankaferd Blood Stopper
mouth wash

Other:
• Bicarbonate
mouth wash

Locations

Country	Name	City	State
Turkey	Bursa Uludag University	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Uludag Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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/s00520-014-22 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	World Health Organization (WHO) Oral Mucositis Evaluation	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)	Up to Day 15
Other	patient education	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.	Up to Day 15
Primary	Personal Information Form	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).	day 1
Primary	ECOG Performance Score (Eastern Cooperative Oncology Group)	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.	Up to Day 15
Primary	Oral Care Control Chart	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.	Up to Day 15
Secondary	Number of participants with abnormal laboratory test results	hemoglobin, hematocrit, neutrofil, body mass index	Up to Day 15