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NCT07900477

Inactivated KAWAI Bacteria for Diarrhea Prevention During Pelvic Radiotherapy in Postoperative Cervical Cancer

Sponsor: Obstetrics & Gynecology Hospital of Fudan University

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to evaluate whether an oral probiotic supplement (KAWAI inactivated bacteria) can reduce the side effects (especially diarrhea) caused by pelvic external beam radiation therapy in patients who have undergone surgery for cervical cancer. Women aged 18 to 70 who have been diagnosed with cervical cancer, have recently undergone surgery, and are scheduled to receive only pelvic external radiation therapy may be eligible to participate. Participants will be randomly assigned (like flipping a coin) in a 1:1 ratio to receive either the KAWAI supplement or a placebo. They will take the study product starting 7 days before radiation therapy and continue until 6 weeks after the radiation therapy ends. Researchers will closely monitor and compare the occurrence of diarrhea and other side effects between the two groups to see if the KAWAI supplement is safe and effective in improving patients' quality of life during radiotherapy. A total of 100 participants are expected to be enrolled.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Oral Inactivated KAWAI Bacteria on Adverse Reactions of Postoperative Pelvic External Beam Radiotherapy in Cervical Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-10-28

Completion Date

2028-04-01

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Cervical Cancer

Interventions

DIETARY_SUPPLEMENT

KAWAI powder

Oral administration of inactivated KAWAI bacteria. Dose: 4g/day (4 packets) taken twice daily (2 packets in the morning on an empty stomach, 2 packets before dinner before 4:00 PM). Treatment starts 7 days prior to the initiation of pelvic external beam radiotherapy (EBRT) and continues until 6 weeks after the completion of EBRT.

OTHER

Placebo

Oral administration of placebo, matching the KAWAI supplement in appearance, color, smell, and packaging. Dose: 2 packets taken twice daily (before 4:00 PM). Administration starts 7 days prior to the initiation of pelvic EBRT and continues until 6 weeks after the completion of EBRT.

Inclusion Criteria: * Female, aged 18 to 70 years. Histopathologically confirmed cervical cancer, post-surgery, and evaluated based on postoperative pathology to require only pelvic external beam radiotherapy (EBRT). ECOG performance status of 0-1. Adequate major organ function. Provision of written informed consent. Exclusion Criteria: * Presence of diarrheal symptoms within 2 weeks prior to study initiation; or gastrointestinal diseases that may significantly affect gut microbiota or study results, including: (1) inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis); (2) chronic diarrheal diseases (e.g., diarrhea-predominant irritable bowel syndrome, malabsorption syndrome); (3) active peptic ulcer; (4) history of major gastrointestinal surgery (e.g., subtotal gastrectomy, bowel resection; appendectomy is excluded); (5) other gastrointestinal diseases judged by the investigator to potentially interfere with study results or affect subject safety. High-risk factors in postoperative pathology such as positive margins requiring brachytherapy; or lymph node metastasis, parametrial invasion. Requirement for concurrent chemotherapy during pelvic EBRT based on postoperative pathology. Prior radiotherapy or pelvic malignancies. Uncontrolled acute reproductive tract infection. Immunosuppressive disease or use of systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressants within 3 months. Use of any probiotics (live or dead), prebiotics, or synbiotics within 1 month. Allergy to probiotics or history of severe food allergy. Severe heart, liver, kidney, or gastrointestinal diseases. Participation in other clinical trials or receipt of investigational drugs/vaccines within 30 days. Other factors judged by the investigator that may affect study results or lead to early termination, such as alcoholism, drug abuse, severe comorbidities (including mental illness) requiring concurrent treatment, severe laboratory abnormalities, or family/social factors affecting subject safety.