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The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients

NCT05138627 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-12-01

No results posted yet for this study

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. 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

Interventions

OTHER

oral cryotherapy

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.

Sponsors & Collaborators

  • Berna KURT

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2021-05-17
Completion
2021-05-17

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05138627 on ClinicalTrials.gov