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

NCT05138627 | Completed DMC

• 1 other identifier: KA-20007
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

nursing; nausea vomiting; randomized controlled trial; oral cryotherapy

Outcome Measures

Primary Outcomes (1)

• Rhodes Index of Nausea Vomiting and Retching (RINVR)

  The scale has three sub-dimensions as symptom experience, symptom occurrence, and symptom distress.

  during four cycles of chemotherapy (each cycle is 21 days)

Secondary Outcomes (1)

• EORTC QLQ-C30 Life Quality Index (EORTC QLQ-C30)

  during four cycles of chemotherapy (each cycle is 21 days)

Study Arms (2)

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

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.

Interventions

oral cryotherapy OTHER

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.

intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Treatment delayed at least two times in a row
• Unreachable through phone calls
• Changed treatment regimen/drugs
• Patients who stopped participating in the study.

Sponsors & Collaborators

• Berna KURT: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Berna Çakmak Öksüzoğlu, Professor

  bernacolakoglu85@gmail.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled study

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: December 1, 2021
• Study Start: July 21, 2020
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

TU (1)