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Completed
NCT05736315
Use of a Fermented Dairy Beverage in Cervical Cancer Patients Undergoing Concurrent Chemoradiation Therapy
Conditions: Cervical Cancer, Stage IIB
Sex: Female
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 42
Sponsor: National Institute of Cancerología
Location: Mexico
Summary
Many cancer survivors have increased risk of intestinal damage, affecting the quality of life of patients.
The role of intestinal microbiota on the development of gastrointestinal toxicity and radiation enteritis has been described in cervical cancer patients that received pelvic RT.
In this project we investigated the effect that a fermented dairy beverage (Yakult) may have in the modulation of inflammation and consequently of gastrointestinal toxicity in locally advanced cervical cancer (LACC) patients treated with concomitant chemo-radiotherapy (CRT).
Eligibility Criteria
Inclusion Criteria:Histological confirmation of cervical cancer staged as IIB.Histology: Epidermoid, adenosquamous, and adenocarcinomaWithout previous treatmentMeasurable diseaseAge between 18 and 70 yearsFunctional status of 0-2 (WHO criteria)Normal hematological, renal and hepatic functionStandard chest X-rayInformed consentExclusion Criteria:Patients with small cell carcinoma or other rare histologies (sarcomas, lymphomas)Patients with other clinical stagesPatients with paraaotic nodes less than or equal to 1 cm.Patients with non-measurable diseaseInfections or serious diseases that prevent the use of chemotherapyConcomitant treatment with another experimental drugPregnancy or lactationMental diseasesPatients with previously documented hypersensitivity reactions to lactobacilli.Diabetic patients or hyperglycemia higher than 145 mg/dL.Previous or concomitant malignancy except non-melanoma skin carcinomaSocial, family or geographical conditions that suggest a poor adherence to the study.
Source: ClinicalTrials.gov (NCT05736315). StuddyBuddy aggregates publicly available trial information.