Trial Title:
Oral Cryotherapy Applied to Patients Undergoing Chemotherapy
NCT ID:
NCT06594354
Condition:
Oncologic Disease
Cancer
Chemotherapy
Conditions: Official terms:
Malnutrition
Conditions: Keywords:
Appetite
chemotherapy
malnutrition
taste dysfunction
cryotherapy
quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Health Services Research
Masking:
Single (Care Provider)
Masking description:
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.
Intervention:
Intervention type:
Other
Intervention name:
ICE
Description:
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 "
Arm group label:
Intervention arm
Other name:
oral ice application
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
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Recep Tayyip Erdogan University
Address:
City:
Rize
Zip:
53100
Country:
Turkey
Facility:
Name:
Recep Tayyip Erdoğan University Training and Research Hospital
Address:
City:
Rize
Zip:
53100
Country:
Turkey
Facility:
Name:
Recep Tayyip Erdoğan University
Address:
City:
Rize
Zip:
53100
Country:
Turkey
Start date:
July 1, 2024
Completion date:
August 2025
Lead sponsor:
Agency:
Karadeniz Technical University
Agency class:
Other
Source:
Karadeniz Technical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06594354
