Breast CancerNCT05138627
The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients
A study testing oral cryotherapy in people with Breast Cancer, run by Berna KURT at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this randomized controlled, statistical blind study that has an intervention control group was to determine the effect of oral cryotherapy on anticipatory, acute, and late nausea and vomiting of breast cancer patients receiving adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- oral cryotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jul 2020to 17 May 2021
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
The inclusion criteria were as follows;
- Between the ages of 18- 65
- Open to communication and cooperation, literate
- Knowing about their diagnosis
- Diagnosed with breast cancer for the first time
- Adjuvant chemotherapy protocol planned for the first time
- Receiving AC Protocol as chemotherapy protocol
- Who did not receive radiotherapy treatment before adjuvant chemotherapy
- Who does not have COPD, AMI, CHF, CRF, Gastrointestinal, Neurological, Metabolic, pregnancy and non-DM
- Who did not use a non-pharmacological method for nausea-vomiting
- Who received standard antiemetic therapy in accordance with the AC protocol
- Who does not have metastasis
- Who does not have thrombocytopenia
- Who has Stage I and Stage II breast cancer
- Who is not treated for psychiatric and/or depression
- Consisted of female patients who were willing and voluntarily to participate in the study.
The exclusion criteria were as follows;
- Treatment delayed at least two times in a row
- Unreachable through phone calls
- Changed treatment regimen/drugs
- Patients who stopped participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients Receiving Adjuvant Chemotherapy Treatment
The purpose of this randomized controlled, statistical blind study that has an intervention control group was to determine the effect of oral cryotherapy on anticipatory, acute, and late nausea and vomiting of breast cancer patients receiving adjuvant chemotherapy. The study was carried out between July 2020-May 2021 in the Unit of the Medical Oncology Department of University of Health Sciences Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. The study sample consisted of 54 breast cancer patients. 26 patients belonged to the intervention group and 28 to the control group. They were stratified based on their ages and body surface areas and were planned to receive chemotherapy for four cycles. The Oral Cryotherapy Protocol; developed by the researcher was made by obtaining opinions of five academic members and physics engineers and chemical engineers. Nausea and vomiting training guide and education was given to all patients in the study to avoid discrimination. The intervention group of the study applied oral cryotherapy with the researcher when they came to the hospital for the treatment and at home. No procedure outside of the routine treatment was performed on patients in the control group. Data in the study were collected through the Patient Information Form, the Rhodes Index of Nausea Vomiting and Retching (RINVR), and the EORTC QLQ-C30 Life Quality Index. The effect of oral cryotherapy was measured by the RINVR by contacting the patients every day for the first week during four cycles. EORTC QLQ-C30 and RINVR were conducted on patients when they came to the hospital throughout their cycles.
Read the detailed description
Nausea-vomiting (80%) is the leading symptom associated with chemotherapy. The chemotherapeutic regimen's emetogenicity is effective in the emergence of chemotherapy-induced nausea-vomiting (CINV). In CINV, centers such as the cerebral cortex and the gastrointestinal tract stimulated the Chemoreceptor Trigger Zone (CTZ). Cytotoxic drugs can easily reach the CTZ. Various emetogenic cause serotonin release from enterochromaffin cells in the gastrointestinal tract. Serotonin stimulates CTZ in the central nervous system, and emesis develops. Despite the antiemetic drugs given to prevent the side effects of chemotherapy drugs, 60% of patients experience nausea and vomiting. Adriamycin Cyclophosphamide (AC) chemotherapy agents often cause nausea and vomiting between 1-7th days after the treatment. When CINV cannot be controlled effectively and adequately, anticipatory nausea and vomiting develop, especially within 24 hours before chemotherapy treatment, and a learned reflex mechanism occurs. It is stated that uncontrolled anticipatory nausea and vomiting in adult patients triggers acute and late nausea and vomiting. It is indicated that approximately 70% of the patients who received chemotherapy treatment between the first and fifth days experienced vomiting at least once, and 80% of the patients experienced nausea at least once.
The guideline for the prevention and management of nausea-vomiting published by the Oncology Nursing Society (ONS) states that the use of non-pharmacological approaches together with pharmacological methods may be appropriate. One of the nonpharmacological applications recommended in the management of chemotherapy-related symptoms is oral cryotherapy. Cryotherapy is the process of cooling the tissues by utilizing the effect of pieces of ice. Cryotherapy causes local vasoconstriction when used in treatment with intravenously administered chemotherapy agents. The local effect of ice application in preventing muscle damage is that it causes vasoconstriction in blood and lymph vessels, reducing the inflammatory response and activation of some proteins. The most important neuroreceptors in the formation of the emetic response are serotonin, substance-P, dopamine, acetylcholine, corticosteroid, and histamine. The most important neurotransmitters are dopamine, serotonin, and substance-P. Substance-P stimulates cholinergic neurons, causing vasodilation, increased secretion, and smooth muscle contraction. This way, it triggers vomiting by stimulating the CTZ.
- Conditions
- Breast Cancer
- Being tested
- oral cryotherapy
- Keywords
- nursing, nausea vomiting, randomized controlled trial, oral cryotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral cryotherapyOther
Ice application protocol developed by the researcher by scanning the literature was prepared by taking the opinions of 5 faculty members who are experts in their fields. Also, the chamber of physics engineers and the chamber of chemical engineers' opinion was taken for the necessary corrections or improvements regarding the chemical/physical structure of the ice and the method applied. In the content of the protocol, materials, preparation before intraoral ice application (written and visual), steps of intraoral ice application (written and visual), termination of intraoral ice application, recording of intraoral ice application, and situations to be considered are explained in detail respectively.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 1. Teaching of oral cryotherapy by the investigator in the hospital,
2. Implementation of oral cryotherapy accompanied by the investigator in the hospital
3. Individual application of oral cryotherapy at home by patients Receives: Other: oral cryotherapy |
| control | No intervention | Routine procedures in the clinic were performed on the first course (day 0) when the patients came to receive adjuvant chemotherapy and every 21 days thereafter, and oral cryotherapy was not applied to the patients. Before applying the first adjuvant chemotherapy, Nausea Vomiting Training and Guide was given to have equal conditions with the patients in the intervention groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhodes Index of Nausea Vomiting and Retching (RINVR)
The scale has three sub-dimensions as symptom experience, symptom occurrence, and symptom distress.
Measured: during four cycles of chemotherapy (each cycle is 21 days)
Secondary outcomes (1)
EORTC QLQ-C30 Life Quality Index (EORTC QLQ-C30)
The scale consists of three sub-dimensions as general well-being, functional difficulties, and symptom control.
Measured: during four cycles of chemotherapy (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start21 Jul 2020
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berna KURT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berna KURT, Hacettepe University
- Investigators
- Berna Çakmak Öksüzoğlu, Professor, Study director, bernacolakoglu85@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138627
- Sponsor's protocol ID
- KA-20007
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients Receiving Adjuvant Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT05138627
- Acronym / sponsor ID
- KA-20007
- Conditions
- Breast Cancer
- Keywords
- nursing, nausea vomiting, randomized controlled trial, oral cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Berna KURTUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 1 Dec 2021 (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.
The purpose of this randomized controlled, statistical blind study that has an intervention control group was to determine the effect of oral cryotherapy on anticipatory, acute, and late nausea and vomiting of breast cancer patients receiving adjuvant chemotherapy. The study was carried out between July 2020-May 2021 in the Unit of the Medical Oncology Department of University of Health Sciences Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. The study sample consisted of 54 breast cancer patients. 26 patients belonged to the intervention group and 28 to the control group. They were stratified based on their ages and body surface areas and were planned to receive chemotherapy for four cycles. The Oral Cryotherapy Protocol; developed by the researcher was made by obtaining opinions of five academic members and physics engineers and chemical engineers. Nausea and vomiting training guide and education was given to all patients in the study to avoid discrimination. The intervention group of the study applied oral cryotherapy with the researcher when they came to the hospital for the treatment and at home. No procedure outside of the routine treatment was performed on patients in the control group. Data in the study were collected through the Patient Information Form, the Rhodes Index of Nausea Vomiting and Retching (RINVR), and the EORTC QLQ-C30 Life Quality Index. The effect of oral cryotherapy was measured by the RINVR by contacting the patients every day for the first week during four cycles. EORTC QLQ-C30 and RINVR were conducted on patients when they came to the hospital throughout their cycles.
Detailed description
Nausea-vomiting (80%) is the leading symptom associated with chemotherapy. The chemotherapeutic regimen's emetogenicity is effective in the emergence of chemotherapy-induced nausea-vomiting (CINV). In CINV, centers such as the cerebral cortex and the gastrointestinal tract stimulated the Chemoreceptor Trigger Zone (CTZ). Cytotoxic drugs can easily reach the CTZ. Various emetogenic cause serotonin release from enterochromaffin cells in the gastrointestinal tract. Serotonin stimulates CTZ in the central nervous system, and emesis develops. Despite the antiemetic drugs given to prevent the side effects of chemotherapy drugs, 60% of patients experience nausea and vomiting. Adriamycin Cyclophosphamide (AC) chemotherapy agents often cause nausea and vomiting between 1-7th days after the treatment. When CINV cannot be controlled effectively and adequately, anticipatory nausea and vomiting develop, especially within 24 hours before chemotherapy treatment, and a learned reflex mechanism occurs. It is stated that uncontrolled anticipatory nausea and vomiting in adult patients triggers acute and late nausea and vomiting. It is indicated that approximately 70% of the patients who received chemotherapy treatment between the first and fifth days experienced vomiting at least once, and 80% of the patients experienced nausea at least once.
The guideline for the prevention and management of nausea-vomiting published by the Oncology Nursing Society (ONS) states that the use of non-pharmacological approaches together with pharmacological methods may be appropriate. One of the nonpharmacological applications recommended in the management of chemotherapy-related symptoms is oral cryotherapy. Cryotherapy is the process of cooling the tissues by utilizing the effect of pieces of ice. Cryotherapy causes local vasoconstriction when used in treatment with intravenously administered chemotherapy agents. The local effect of ice application in preventing muscle damage is that it causes vasoconstriction in blood and lymph vessels, reducing the inflammatory response and activation of some proteins. The most important neuroreceptors in the formation of the emetic response are serotonin, substance-P, dopamine, acetylcholine, corticosteroid, and histamine. The most important neurotransmitters are dopamine, serotonin, and substance-P. Substance-P stimulates cholinergic neurons, causing vasodilation, increased secretion, and smooth muscle contraction. This way, it triggers vomiting by stimulating the CTZ.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: oral cryotherapy1. Teaching of oral cryotherapy by the investigator in the hospital, 2. Implementation of oral cryotherapy accompanied by the investigator in the hospital 3. Individual application of oral cryotherapy at home by patients |
| control | No intervention | –Routine procedures in the clinic were performed on the first course (day 0) when the patients came to receive adjuvant chemotherapy and every 21 days thereafter, and oral cryotherapy was not applied to the patients. Before applying the first adjuvant chemotherapy, Nausea Vomiting Training and Guide was given to have equal conditions with the patients in the intervention groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| oral cryotherapyIce application protocol developed by the researcher by scanning the literature was prepared by taking the opinions of 5 faculty members who are experts in their fields. Also, the chamber of physics engineers and the chamber of chemical engineers' opinion was taken for the necessary corrections or improvements regarding the chemical/physical structure of the ice and the method applied. In the content of the protocol, materials, preparation before intraoral ice application (written and visual), steps of intraoral ice application (written and visual), termination of intraoral ice application, recording of intraoral ice application, and situations to be considered are explained in detail respectively. | Other | intervention |
Primary outcome
Rhodes Index of Nausea Vomiting and Retching (RINVR)
Time frame: during four cycles of chemotherapy (each cycle is 21 days)
The scale has three sub-dimensions as symptom experience, symptom occurrence, and symptom distress.
1 secondary outcome
EORTC QLQ-C30 Life Quality Index (EORTC QLQ-C30)
Time frame: during four cycles of chemotherapy (each cycle is 21 days)
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 1 Dec 2021.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Berna Çakmak Öksüzoğlu, Professor study director
bernacolakoglu85@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral cryotherapy in people with Breast Cancer, run by Berna KURT at 1 site 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?
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 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rhodes Index of Nausea Vomiting and Retching (RINVR) (time frame: during four cycles of chemotherapy (each cycle is 21 days)). 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 1 Dec 2021.