Clinical trial · Interventional
The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients
The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients Receiving Adjuvant Chemotherapy Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral cryotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- intervention
- description
- 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
- interventionNames
- Other: oral cryotherapy
- type
- NO_INTERVENTION
- label
- control
- description
- 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.
Primary outcomes (1)
- measure
- Rhodes Index of Nausea Vomiting and Retching (RINVR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available