The Effect of Oral Cryotherapy on Anticipatory, Acute and Late Nausea and Vomiting in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Nausea; Vomiting
Study type: Interventional

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.
    

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.
    

Intervention name(s): oral cryotherapy
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: nursing; nausea vomiting; randomized controlled trial; oral cryotherapy