Oral Cryotherapy Applied to Patients Undergoing Chemotherapy

NCT06594354 | Completed

• 1 other identifier: KTU-SBF-ZPK-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

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.

Conditions

Oncologic Disease; Cancer; Chemotherapy

Keywords

Appetite; chemotherapy; malnutrition; taste dysfunction; cryotherapy; quality of life

Outcome Measures

Primary Outcomes (5)

• Chemotherapy-Induced Taste Alteration Scale (C-TAS)

  The scale was developed by Kano and Kanda in 2013. The scale was developed to reveal the effects of chemotherapy-induced taste changes on the individual. The validity and reliability study of the scale in Turkey was conducted by Sözeri and Kutlutürkan in 2014. In the validity and reliability study, the Cronbach alpha value of the scale was found to be 0.86. The scale consists of three subheadings, four subdimensions as "Reduction in the Perception of Basic Tastes", "Phantogeusia and Parageusia", "Discomfort" and "General Taste Changes" and a total of 18 items in a five-point Likert type (1-normal taste, 5-no taste). The scores obtained from the scale subdimensions are used in the evaluation of the scores obtained from the scale. The scores obtained from the scale subdimensions are obtained by summing up those items and dividing them by the number of items. The maximum score that can be obtained from the subdimensions and the total scale score is five, while the minimum score is one.

  two months

• Simplified Nutritional Appetite Questionnaire (SNAQ)

  This questionnaire, which was developed in a simple and understandable way to measure the appetite of patients, was developed by Wilson et al. in 2005 and the Cronbach alpha value was found to be 0.70. The validity and reliability of the questionnaire in Turkish was conducted by Tatar et al. in 2021 and the Cronbach alpha coefficient was found to be 0.86. The scale consists of four questions and each question has five options (a = 1 point, b = 2 points, c = 3 points, d = 4 points, e = 5 points) and is scored between 4 and 20 points in total. If the patient\'s score from the questionnaire is 14 points or less, this indicates that the individual is at risk for 5% weight loss in the last six months. As the total score from the questionnaire decreases, the appetite level worsens.

  two months

• Malnutrition Universal Screening Tool (MUST)

  It is a five-step screening method recommended by the European Society of Parenteral and Enteral Nutrition (ESPEN) and the British Association for Parenteral and Enteral Nutrition (BAPEN). The scale consists of three sections (malnutrition, malnutrition risk and obesity). Malnutrition risk is classified as low, medium and high. Scores from the categories of "Body Mass Index (BMI)", "Unexpected Body Weight Loss History" and "Acute Disease Effects" are used in the classification.

  two months

• European Organization for Research and Treatment of Cancer Qıality of Life Questionnaire (EORTC QLQ-30-Version 3.0)

  The EORTC QLQ-C30 was developed by the European Organization for Research and Treatment of Cancer in 1987 to assess the quality of life of cancer patients. The scale was later revised by Aaronson et al. in 1993, and the Cronbach alpha coefficient was found to be 0.70. The EORTC QLQ-C30 consists of three sub-dimensions, namely "general quality of life", "functional functions" (physical, role, cognitive, emotional, social) and "symptom scale" (fatigue, pain, nausea/vomiting, dyspnea, insomnia, anorexia, constipation, diarrhea, financial difficulties) and 30 questions. The first 28 of the scale questions are of the four-point Likert type (not at all-1; very much-4). High scores from the first 28 questions indicate low quality of life, while low scores indicate high quality of life. The 29th and 30th questions of the scale are questions that constitute the general quality of life domain.

  two months

• Introductory information form

  This form prepared by the researchers includes three sections. The first part includes eight questions about the sociodemographic characteristics of the patients (age, gender, marital status, employment status, etc.), the second part includes nine questions about the cancer disease and the treatment method applied (cancer type, stage, metastasis status, number of cures, chemotherapy regimen). etc.) and the third part consists of a total of 31 questions, 13 of which include questions about taste changes, appetite and malnutrition (appetite status, oral care, etc.).

  two months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Patients in this arm will receive oral cryotherapy.The patients in the intervention group will have ice applied to their mouths for three cycles (the first cycle they met with the researcher and the second and third cycles/an average of two months) when they come for treatment at the hospital with the researcher and at home on the days they do not come for treatment, within the scope of the oral cryotherapy application protocol, they 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 in the same time period, three consecutive ice cubes (each ice cube melts for an average of 1.5-2 minutes/total average of 4.5-6 minutes) 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 minutes/day) at two or three hour intervals for seven days, including the day they receive che

Other: ICE

Control arm

NO INTERVENTION

Patients who meet the study criteria and are included in the control group will receive routine treatment and care procedures in the unit when they come to receive chemotherapy (the first cycle encountered by the researcher) and the other two cycles that follow, and will not receive oral cryotherapy.

Interventions

ICE OTHER

The patients in the intervention group will have ice applied to their mouths for three cycles (the first cycle they met with the researcher and the second and third cycles/an average of two months) when they come for treatment at the hospital with the researcher and at home on the days they do not come for treatment, within the scope of the oral cryotherapy application protocol, they 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 in the same time period, three consecutive ice cubes (each ice cube melts for an average of 1.5-2 minutes/total average of 4.5-6 minutes) 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 minutes/day) at two or three hour intervals for seven days, including the day they receive chemotherapy, and to record their applications on the "

Also known as: oral ice application

Intervention arm

Eligibility Criteria

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

You may qualify if:

• Those receiving treatment in an outpatient chemotherapy unit,
• Able to communicate verbally,
• Literate,
• Eastern Cooperative Oncology Group (ECOG) Performance Score of two or below,
• Knowing their diagnosis,
• Taking five chemotherapeutic agents that cause taste changes, either alone or in combination (cisplatin, docetaxel, paclitaxel, oxaliplatin, vincristine),
• Verbally stating that they experience taste changes,
• Not smoking or quitting alcohol,
• Not using statins, hypothyroidism, antidiabetic, antipsychotic, hyperthyroidism, antidepressant, antihistamine, anti-inflammatory, antibiotic and antifungal drugs,
• Not having Chronic Renal Failure (CKD), metabolic (diabetes, thyroid disease, etc.) and liver (hepatitis, cirrhosis) diseases,
• Individuals who volunteered to participate in the study were included in the study.

You may not qualify if:

• Patients who have had their treatment postponed at least twice in a row,
• Those with a World Health Organization Oral Toxicity Scale score of 1 and above,
• Those who have received radiotherapy to the head and neck region,
• Those with head/neck, stomach and liver cancer,
• Those who cannot be reached during phone calls,
• Those whose chemotherapy protocol has changed or who will be applied to a protocol other than the specified agents,
• Those with neutropenia (neutrophils; 1000 mcL and below),
• Those with tooth sensitivity,
• Those who have experienced a change in taste before starting the chemotherapy protocol\*\* and
• Those who do not want to continue the study will be excluded from the study.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (3)

Recep Tayyip Erdogan University

Rize, Rize Province, 53100, Turkey (Türkiye)

Location

Recep Tayyip Erdoğan University Training and Research Hospital

Rize, Rize Province, 53100, Turkey (Türkiye)

Location

Recep Tayyip Erdoğan University

Rize, Rize Province, 53100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Malnutrition; Taste Disorders

Interventions

Ice

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Zeynep PEHLİVAN KÖKSAL, Masters

  Recep Tayyip Erdogan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The data obtained from the study will be collected using a simple randomization method and a computerized randomization program will be used (www.randomizer.org). The groups determined in the program will be the intervention group and the control group; Group 1 and Group 2 will be written on two different papers and will be determined by the chemotherapy unit nurse by drawing lots. Patients who meet the sampling criteria will be divided into two randomized groups as patients who will be applied intraoral ice (intervention group) and patients who will not be applied (control group). Patients who meet the study inclusion criteria will be numbered and delivered to the researcher by the chemotherapy unit nurse on each application day. The patient will be included in the group according to the number given to the patient.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Oral cryotherapy is a safe, cost-effective and easily applicable important nursing intervention used in addition to oral care in patients receiving chemotherapy, especially to prevent or reduce the severity of oral mucositis. The effectiveness of oral cryotherapy, known as the application of ice or cold water to the oral cavity, in the management of taste alteration is emphasized.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion: October 20, 2024
• Study Completion: June 1, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)