Effect of Beta Glucan on Oncological Outcomes in Cervical Cancer Patients Undergoing Concurrent Chemoradiation: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Phase 2

• Conditions: ocally advanced cervical cancer; Locally advanced cervical cancer, Concurrent chemoradiation, Beta Glucan

• Registration Number: TCTR20220210006
• Lead Sponsor: Faculty of Medicine, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-10
• Last Update Posted: 19 August 2024
• Study Completion: 2025-03-07

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 286

Inclusion Criteria

Patients must have:
- Cervical cancer FIGO stage IB2-IVA (FIGO 2018)
- Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma
- ECOG performance status 0-2
- No history of other cancer
- Adequate bone marrow function (WBC > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3)
- Bilirubin < 1.5 folds, SGOT/ SGPT < 1.5 folds of normal limit, creatinine clearance > or = 40 mg/dl
- Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures

Exclusion Criteria

- has received prior systemic chemotherapy or radiotherapy at any time for cervical cancer
- Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI
- Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
- Pregnancy or lactation
- Patients with infection or inflammatory conditions or on oral/topical antimicrobials or use antiseptic solution for vaginal wash in the past 3 weeks.
- had previous exposure to beta glucan products.
- Allergy to the study drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival 3 years Kaplan Mier

Secondary Outcome Measures

Name	Time	Method
Progression-free survival 3 years Kaplan Mier,Response rate 3 months after completion of CCRT percentages of response,Adverse event during or up to 6 months after treatment percentages