Jianzhong Qushi in Chronic RRI
ConditionChronic Radiation Proctitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
This study is a multicenter, randomized, double-blind, placebo-controlled trial. Patients diagnosed as CRP and without TCM history will be enrolled and randomly assigned to either the treatment group (receiving standard care plus Jianzhong Qushi Formula, 100 ml bid, \*28days) or the control group (receiving standard care plus placebo 100 ml bid, \*28days). All of the patients received both The primary endpoint is the clinical response rate, defined as fulfilling one of the following, RTOG grade reduction, ① RTOG/EORTC grade reduction; ② ≥1 symptom downgraded by CTCAE v5.0; ③ Symptom improvement according to TCM symptom standards .The secondary endpoints included TCM syndrome score reduction rate, LENT/SOMA score changes, changes in gut microbiota, quality of life(QoL) , etc. Totally, 168 patients (84 in each group) will be enrolled.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ;
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Jianzhong Qushi Formula
DrugJianzhong Qushi Formula (A Chinese traditional formula, approved by Chinese Patent, No. ZL202210097886.0)
Placebo
DrugA simulated Chinese medicine placebo, with similar appearance and smell to Jianzhong Qushi Formula.
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: Jianpi AnChang GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Response rate
① A downgrade in the RTOG/EORTC radiation proctitis grading; ② A downgrade in the evaluation of ≥1 radiation enteritis - related symptom according to the National Cancer Center of the United States Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0 ); ③ Syndrome: alleviation of 2 main symptoms or 1 main symptom + 2 secondary symptoms
Time frame
1-month, 3-month, 6-monthSecondary outcomes
1
Change of TCM syndrome scores: Calculated as (Pre-treatment Syndrome Score - Post-treatment Syndrome Score) / Pre-treatment Syndrome Score×100%. (Refer to the relevant standards in the "Guiding Principles for Clinical Research on New Traditional
Higher means better
Time frame
1-month, 3-month, 6-month2
Changes in Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scales
Fewer score means better
Time frame
1-month, 3-month, 6-month3
Changes in Quality of Life Scores
Higher score means better
Time frame
1-month, 3-month, 6-month4
Changes in intestinal flora
Time frame
1-month, 3-month, 6-monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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