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Effect of Kefir on Symptom Management and Quality of Life in Oncology

NCT06517420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-07-24

No results posted yet for this study

Summary

This study was planned as a randomized controlled prospective experimental study to determine the effect of kefir on symptom management and quality of life in oncology patients receiving chemotherapy. The population of the study consisted of 600 cancer patients who received chemotherapy in the outpatient chemotherapy unit of a university hospital between June 1, 2023 and February 1, 2024.

G\*Power 3.1 package program was used to determine the number of samples. The sample size to ensure the power of the test (1-β = 0.80) was determined as a minimum of 26 people for each group. Considering the possibility of losses, 106 patients were included in the study. Data from 22 patients who were followed up during the preparation phase of the study were not included in the study. Simple random sampling method was used to avoid bias in providing patients to be included in the study before the data collection phase. With the computer-based randomization method, patients were numbered in the order of arrival and divided into experimental and control. The sample of the study was determined as 84, 42 in the experimental group and 42 in the control group.

In collecting data, "Individual Information Form, Nightingale Symptom Assessment Scale (NSD-S), FACT-G Quality of Life Scale, WHO Mucositis Evaluation Form, Rhodes Nausea Vomiting Gagging Index, ASCO Diarrhea Assessment Scale and Constipation Assessment Scale" were used. CAS)" was used.

Conditions

Interventions

OTHER

kefir consumption

Support and information was received from the Food Technology Department of a university's Experimental Medicine Application and Research Center. It was decided to choose the kefir to be used, which is produced from pasteurized cow's milk, lactase enzyme, probiotic culture (B. Lactis) and kefir culture, will meet the B12 need, contribute to increasing vitality and energy, and has the most suitable content in the market. Kefir, supplied by the researcher, was given to the patients at the end of each session in the amount that the patients should consume for a week, following the cold chain rule. While consuming kefir, it was recommended to gargle it in the mouth, hold it for a while, and then swallow. Patients were contacted for a week after the session to ensure that they applied kefir correctly.

Sponsors & Collaborators

  • Izmir Bakircay University

    lead OTHER

Principal Investigators

  • Olçun Ümit ÜNAL, Assos. Prof. · HSU-Izmir Tepecik Training and Research Hospital, Bornova Oncology Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-08-21
Completion
2024-02-01

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 NCT06517420 on ClinicalTrials.gov