Clinical trial · Interventional
Use of a Fermented Dairy Beverage in Cervical Cancer Patients Undergoing Concurrent Chemoradiation Therapy
Phase II Randomized, Double Blind Study of Probiotics in Patients With Cervical Cancer in Clinical Stages IIB Undergoing Concurrent Chemotherapy and Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer, Stage IIB | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo dairy beverage | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fermented dairy beverage
- description
- Concumption of 3 servings of the fermented dairy beverage a day, during oncological treatment.
- interventionNames
- Other: Placebo dairy beverage
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Consumption of 3 servings of the placebo dairy beverage a day, during oncological treatment.
- interventionNames
- Other: Placebo dairy beverage
Primary outcomes (1)
- measure
- Clinical toxicity
- timeFrame
- Change from baseline up to 3 months after treatment finished
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of cervical cancer staged as IIB. * Histology: Epidermoid, adenosquamous, and adenocarcinoma * Without previous treatment * Measurable disease * Age between 18 and 70 years * Functional status of 0-2 (WHO criteria) * Normal hematological, renal and hepatic function * Standard chest X-ray * Informed consent Exclusion Criteria: * Patients with small cell carcinoma or other rare histologies (sarcomas, lymphomas) * Patients with other clinical stages * Patients with paraaotic nodes less than or equal to 1 cm. * Patients with non-measurable disease * Infections or serious diseases that prevent the use of chemotherapy * Concomitant treatment with another experimental drug * Pregnancy or lactation * Mental diseases * Patients with previously documented hypersensitivity reactions to lactobacilli. * Diabetic patients or hyperglycemia higher than 145 mg/dL. * Previous or concomitant malignancy except non-melanoma skin carcinoma * Social, family or geographical conditions that suggest a poor adherence to the study.
References
Publications (0)
Data not yet available