The Effects of Ankaferd Blood Stopper

NCT05438771 | Unknown DMC

• 1 other identifier: Bursa Uludag University
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer; Oral Mucositis; Nurse's Role; Chemotherapy Effect

Keywords

Colorectal cancer,; Oral Mukozit; Ankaferd Blood Stopper

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Number of participants with abnormal laboratory test results

  Up to Day 15

Other Outcomes (2)

• World Health Organization (WHO) Oral Mucositis Evaluation

  Up to Day 15

• patient education

  Up to Day 15

Study Arms (2)

Bicarbonate

ACTIVE COMPARATOR

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,

Other: Bicarbonate

Ankaferd Blood Stopper

EXPERIMENTAL

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.

Combination Product: Ankaferd Blood Stopper

Interventions

Ankaferd Blood Stopper COMBINATION_PRODUCT

mouth wash

Also known as: brushing teeth

Ankaferd Blood Stopper

Bicarbonate OTHER

mouth wash

Also known as: brushing teeth

Bicarbonate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University

Bursa, 16100, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 31286226 RESULT

• 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.

  PMID: 16041502 RESULT

• 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.

  PMID: 31631858 RESULT

• 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.

  PMID: 18304416 RESULT

• 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.

  PMID: 25596649 RESULT

• 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.

  PMID: 24854326 RESULT

• 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.

  PMID: 9659518 RESULT

• Karacan Y, Yildiz H, Evrensel T, Haznedaroglu IC. The effects of Ankaferd hemostat on preventing oral mucositis in colorectal cancer patients receiving chemotherapy. Support Care Cancer. 2023 Jun 8;31(7):385. doi: 10.1007/s00520-023-07856-7.

  PMID: 37289263 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Stomatitis; Colorectal Neoplasms

Interventions

ankaferd blood stopper; Toothbrushing; Bicarbonates

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Mouth Diseases; Stomatognathic Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Anions; Ions; Electrolytes

Study Officials

• Hicran Yıldız

  Hicran Yıldız

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study was designed as a randomized controlled experimental study on patients newly diagnosed with colorectal cancer who would receive the first course of FOLFOX combination chemotherapy.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: June 30, 2022
• Study Start: June 1, 2021
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)