Oncologic DiseaseNCT06594354
Oral Cryotherapy Applied to Patients Undergoing Chemotherapy
A study testing ICE in people with Oncologic Disease and Cancer, run by Karadeniz Technical University at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Disease, Cancer, Chemotherapy
- What is being tested?
- ICE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Show all 11Show fewer
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Recep Tayyip Erdogan University
Rize, Rize Province, 53100
Recep Tayyip Erdoğan University Training and Research Hospital
Rize, Rize Province, 53100
Recep Tayyip Erdoğan University
Rize, Rize Province, 53100
About this study
Official title: Examining the Effect of Oral Cryotherapy Applied to Patients Undergoing Chemotherapy on Taste Change, Appetite Level, Malnutrition Risk and Quality of Life
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.
Read the 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 effectiveness.Therefore, 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 life.The patients included in the study will be divided into two groups by simple randomization method: patients who will receive ice cubes in the mouth (intervention/oral cryotherapy group) and patients who will not receive the application (control group).This 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 study.Patients 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 study.Patients 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 head/neck, 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 study.The 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 3.0)".Before 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 courses/an 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 1.5-2 minutes to melt/total average of 4.5-6 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 minutes/day) 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 Form".At 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.
- Conditions
- Oncologic Disease, Cancer, Chemotherapy
- Being tested
- ICE
- Keywords
- Appetite, chemotherapy, malnutrition, taste dysfunction, cryotherapy, quality of life
- Medical subject headings
- Neoplasms, Malnutrition, Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICEOther
Also called oral ice application
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 "
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.).
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completion20 Oct 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep PEHLİVAN KÖKSAL, Karadeniz Technical University
- Investigators
- Zeynep PEHLİVAN KÖKSAL, Masters, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594354
- Sponsor's protocol ID
- KTU-SBF-ZPK-01
- Status last verified
- Jun 2025
- First submitted
- 6 Sep 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Oral Cryotherapy Applied to Patients Undergoing Chemotherapy on Taste Change, Appetite Level, Malnutrition Risk and Quality of Life
- ClinicalTrials.gov ID
- NCT06594354
- Acronym / sponsor ID
- KTU-SBF-ZPK-01
- Conditions
- Oncologic Disease, Cancer, Chemotherapy
- Keywords
- Appetite, chemotherapy, malnutrition, taste dysfunction, cryotherapy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 effectiveness.Therefore, 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 life.The patients included in the study will be divided into two groups by simple randomization method: patients who will receive ice cubes in the mouth (intervention/oral cryotherapy group) and patients who will not receive the application (control group).This 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 study.Patients 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 study.Patients 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 head/neck, 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 study.The 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 3.0)".Before 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 courses/an 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 1.5-2 minutes to melt/total average of 4.5-6 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 minutes/day) 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 Form".At 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: ICEPatients 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICEAlso: oral ice applicationThe 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 " | Other | Intervention arm |
Primary outcome
Chemotherapy-Induced Taste Alteration Scale (C-TAS)
Time frame: two months
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.
Simplified Nutritional Appetite Questionnaire (SNAQ)
Time frame: two months
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.
Malnutrition Universal Screening Tool (MUST)
Time frame: two months
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.
European Organization for Research and Treatment of Cancer Qıality of Life Questionnaire (EORTC QLQ-30-Version 3.0)
Time frame: two months
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.
Introductory information form
Time frame: two months
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.).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep PEHLİVAN KÖKSAL, Masters principal investigator
Recep Tayyip Erdogan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICE in people with Oncologic Disease and Cancer, run by Karadeniz Technical University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy-Induced Taste Alteration Scale (C-TAS) (time frame: two months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.