Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594354
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Oral Cryotherapy Applied to Patients Undergoing Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Examining the Effect of Oral Cryotherapy Applied to Patients Undergoing Chemotherapy on Taste Change Appetite Level Malnutrition Risk and Quality of Life
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Taste alteration can cause problems such as loss of appetite inadequate energy intake and weight loss in oncology patients increasing the risk of malnutrition and negatively affecting the quality of life of patients It is thought that other problems mentioned can be prevented and quality of life can be improved with effective management of taste alteration This study was planned as a randomized controlled pre-test-post-test and experimental design to determine the effect of oral cryotherapy application on chemotherapy-induced taste alteration thus on appetite level malnutrition risk and quality of life
Detailed Description:
Taste changes disrupt the nutritional plan of patients causing weight loss and an increased risk of malnutrition and may negatively affect quality of life However this symptom is generally not considered life-threatening and is not considered as important or overlooked by healthcare professionals as other symptoms nausea vomiting oral mucositis pain etc There is limited data in the literature regarding the management of taste changes in patients receiving chemotherapy Studies have shown that oral cryotherapy is a method that can be used in the management of taste changes associated with chemotherapy but more comprehensive studies are needed regarding its effectivenessTherefore this study was planned as a randomized controlled pre-test-post-test and experimental design to determine the effects of oral cryotherapy on chemotherapy-induced taste changes appetite level malnutrition risk and quality of lifeThe patients included in the study will be divided into two groups by simple randomization method patients who will receive ice cubes in the mouth interventionoral cryotherapy group and patients who will not receive the application control groupThis planned study will be conducted with a total of 70 patients 35 in the intervention group and 35 in the control group who received treatment at the Recep Tayyip Erdoğan University Training and Research Hospital Oncology Center Medical Oncology Department Outpatient Chemotherapy Unit between July 2024 and July 2025 and who meet the inclusion criteria for the studyPatients who are receiving treatment in an outpatient chemotherapy unit who can communicate verbally who are literate who know their diagnosis who have an Eastern Cooperative Oncology Group ECOG performance score of 2 or below who are using five chemotherapeutic agents that cause taste alteration alone or in combination cisplatin docetaxel paclitaxel oxaliplatin vincristine who verbally state that they have taste alteration who do not smoke or drink alcohol or have quit who do not use statins hypothyroidism antidiabetic antipsychotic antidepressant hyperthyroidism antidepressant antihistamine anti-inflammatory antibiotic or antifungal medications who do not have Chronic Kidney Disease metabolic and liver cirrhosis disease and who volunteer to participate in the study will be accepted to this studyPatients whose treatment was postponed at least twice in a row who could not be reached by phone calls who had a World Health Organization Oral Toxicity Scale score of 1 and above who had neutropenia neutrophils 1000 μL and below who received radiotherapy to the head and neck region who had headneck stomach and liver cancer who had tooth sensitivity who had a changed chemotherapy protocol or who were to be administered a protocol other than the specified agents who experienced a change in taste before starting the chemotherapy protocol and who did not want to continue the study will be excluded from the studyThe data of the study will be collected using the Introductory Information Form ECOG Performance Scale World Health Organization Oral Toxicity Scale WHOTS Chemotherapy-Induced Taste Alteration Scale C-TAS Simplified Appetite Assessment Questionnaire SNAQ Malnutrition Universal Screening Tool MUST Body Mass Index Monitoring Form Nutritional Parameters Monitoring Form Oral Ice Application Record Form and European Organization for Research and Treatment of Cancer Quality of Life Scale EORTC QLQ-30-Version 30Before starting the study the scales and follow-up forms specified for the intervention oral cryotherapy and control groups will be filled out by the researcher in a face-to-face interview The patients in the intervention group will be subjected to oral ice application protocol during three courses the first course in which the researcher is seen and the second and third coursesan average of two months at the hospital when they come for treatment and at home on the days they do not come for treatment and will be monitored by phone and a reminder message will be sent During chemotherapy ice cubes will be applied to the patients in the first hour they start receiving chemotherapy and three consecutive ice cubes each ice cube takes an average of 15-2 minutes to melttotal average of 45-6 minutes during the same period and the same application will be repeated three hours later The patients will be asked to apply ice cubes at home six times an average of 27-36 minutesday at two or three-hour intervals for seven days including the day they receive chemotherapy and to record their applications on the Oral Ice Application Follow-up FormAt the end of the study approximately two months later the scales will be re-applied to the patients in the intervention and control groups in a face-to-face interview The pre-test and post-test data from the intervention and control groups will be collected by the researcher using a face-to-face interview technique at a time when the patients are receiving chemotherapy and are available
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None