Jianzhong Qushi in Chronic RRI

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Feb 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Jianzhong Qushi Formula for patients with chronic radiation proctitis (CRP), a condition that can occur after pelvic radiotherapy. The trial aims to find out if adding this herbal formula to standard care can help improve symptoms and quality of life for patients. Participants will be randomly assigned to either receive the Jianzhong Qushi Formula or a placebo (a non-active treatment) for 28 days, along with their usual care. The researchers will look at how well the treatment works by measuring changes in symptoms and overall health.

To qualify for the study, participants should be between 18 and 85 years old, have a confirmed diagnosis of CRP, and have completed their radiotherapy at least three months prior. They should also have specific symptoms related to their condition. Patients with other potential causes of their symptoms or those needing urgent treatment for their cancer will not be eligible. If you join the trial, you'll be closely monitored, and your health will be assessed regularly to see how the treatment is affecting you. This study is currently not recruiting participants, so stay tuned for updates if you're interested!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 - 85 years old
• • ECOG score ≤ 2
• • Pathologically confirmed malignant tumor
• • Received pelvic radiotherapy, and it has been ≥ 3 months since the end of radiotherapy ;
• • Meet the diagnostic criteria for chronic radiation proctitis in the "2023 Edition of the Practice Guidelines for the Prevention and Treatment of Radiation Proctitis" or the "2023 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Intestinal Injury in Traditional Chinese and Western Medicine in China", with an international grading of level 1 - 2
• • Meet the syndrome of spleen deficiency , and the syndrome differentiation is determined according to the "2017 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Proctitis (Intestinal Syndrome) in Traditional Chinese Medicine" formulated by the Oncology Branch of the China Association of Traditional Chinese Medicine : Basic Syndrome PRO Scale of Spleen Deficiency (meeting 2 main symptoms or 1 main symptom\* + 2 secondary symptoms#).
• • Hemoglobin ≥ 100 g / L, neutrophils ≥ 1.5 × 10\^9\^ / L
• • Serum creatinine ≤ 1.25 times the upper normal limit (UNL)
• • Total bilirubin ≤ 1.5 times UNL, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times UNL
• • The patient has signed the informed consent form
• • The patient agrees to cooperate with the follow - up. \*Main symptoms included abdominal distension ,anorexia,tenesmus, unsatisfactory bowel movement and fatigue.
• • Secondary symptoms included spontaneous sweating, dizziness,feeling of heaviness in the head, feeling of heaviness in the body, nausea and palpitations.
• Exclusion Criteria:
• • Other causes of enteritis cannot be ruled out
• • The relevant symptoms existed before radiotherapy and did not worsen after treatment
• • Allergy to more than 3 components of the Western medicine used in this study or the formula of Jianzhong Qushi Formula
• • Tumor progression requiring urgent anti-tumor treatment
• • Urgent surgical or endoscopic treatment is needed
• • Has already entered other clinical studies targeting RRI
• • Nursing or pregnant women
• • Those who may interfere with the study evaluation.