Jianzhong Qushi in Chronic RRI

NCT06837597 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: No.24/520-4800
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Radiation Proctitis

Keywords

Chinese Tradiational Medicine; Chronic Radiation Proctitis

Outcome Measures

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

  1-month, 3-month, 6-month

Secondary Outcomes (4)

• 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

  1-month, 3-month, 6-month

• Changes in Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scales

  1-month, 3-month, 6-month

• Changes in Quality of Life Scores

  1-month, 3-month, 6-month

• Changes in intestinal flora

  1-month, 3-month, 6-month

Study Arms (2)

Jianpi AnChang Group

EXPERIMENTAL

Jianzhong Qushi Formula, 100ml twice daily, taken before breakfast and after supper orally, for 28 days.

Drug: Jianzhong Qushi Formula

Placebo Group

PLACEBO COMPARATOR

Simulated Chinese medicine placebo, 100ml twice daily, taken before breakfast and after supper orally, for 28 days.

Drug: Placebo

Interventions

Jianzhong Qushi Formula DRUG

Jianzhong Qushi Formula (A Chinese traditional formula, approved by Chinese Patent, No. ZL202210097886.0)

Jianpi AnChang Group

Placebo DRUG

A simulated Chinese medicine placebo, with similar appearance and smell to Jianzhong Qushi Formula.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Related Publications (6)

• Tabaja L, Sidani SM. Management of Radiation Proctitis. Dig Dis Sci. 2018 Sep;63(9):2180-2188. doi: 10.1007/s10620-018-5163-8.

  PMID: 29948565 BACKGROUND

• Denton A, Forbes A, Andreyev J, Maher EJ. Non surgical interventions for late radiation proctitis in patients who have received radical radiotherapy to the pelvis. Cochrane Database Syst Rev. 2002;(1):CD003455. doi: 10.1002/14651858.CD003455.

  PMID: 11869662 BACKGROUND

• Liu L, Xiao N, Liang J. Comparative efficacy of oral drugs for chronic radiation proctitis - a systematic review. Syst Rev. 2023 Aug 22;12(1):146. doi: 10.1186/s13643-023-02294-2.

  PMID: 37608385 BACKGROUND

• Sahebnasagh A, Ghasemi A, Akbari J, Alipour A, Lashkardoost H, Ala S, Hosseinimehr SJ, Salehifar E. Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients. BMC Complement Med Ther. 2020 May 13;20(1):146. doi: 10.1186/s12906-020-02935-2.

  PMID: 32404169 BACKGROUND

• Vanneste BG, Van De Voorde L, de Ridder RJ, Van Limbergen EJ, Lambin P, van Lin EN. Chronic radiation proctitis: tricks to prevent and treat. Int J Colorectal Dis. 2015 Oct;30(10):1293-303. doi: 10.1007/s00384-015-2289-4. Epub 2015 Jul 23.

  PMID: 26198994 BACKGROUND

• Clarke RE, Tenorio LM, Hussey JR, Toklu AS, Cone DL, Hinojosa JG, Desai SP, Dominguez Parra L, Rodrigues SD, Long RJ, Walker MB. Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow-up. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):134-143. doi: 10.1016/j.ijrobp.2007.12.048. Epub 2008 Mar 14.

  PMID: 18342453 BACKGROUND

Study Officials

• Li Feng, MD.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Yirui Zhai, MD.

CONTACT

+86-10-87788058; januarywind@163.com

Yiyuan Cui, MD.

CONTACT

+86-10-87788030; cuiyiyuan369@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 27, 2025

Record last verified: 2025-02