Concentrated Complex Plant Dietary Elements for Chemotherapy-Induced Diarrhea

NCT07460596 | Completed Phase 2 DMC

• 1 other identifier: TJMUCH-GI-ST02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy-induced diarrhea (CID) is common in patients with gastrointestinal cancer. We evaluated whether the concentrated phytodietary compound (hereafter referred to as CPC) as a nutritional adjuvant to routine anti-diarrheal treatment, acts to alleviate CID in a phase II open-label, single-arm study.

Conditions

Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma; Colon and Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• clinical cure rate of diarrhea

  Clinical cure of diarrhea was defined as two consecutive normal solid stool movements or no stool movements within 12 hours after CPC administration.

  During the first 7 days after CPC administration, record daily the number of bowel movements, stool consistency, gastrointestinal symptoms, BSS score, and the amount of antidiarrheal medications used, such as loperamide and montmorillonite powder.

• 7-day clinical cure rate

  Clinical cure of diarrhea was defined as two consecutive normal solid stool movements or no stool movements within 12 hours after CPC administration.

  Clinical cure of diarrhea was defined as two consecutive normal solid stool movements or no stool movements within 12 hours after CPC administration.

Study Arms (1)

Group 1

EXPERIMENTAL

Dietary Supplement: Concentrated Phytodietary Compound

Interventions

Concentrated Phytodietary Compound DIETARY_SUPPLEMENT

All patients received routine anti-diarrheal treatment plus Concentrated Phytodietary Compound

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 、Age ≥ 18 years; 2、Patients with gastrointestinal tumors currently receiving chemotherapy with irinotecan or fluorouracil agents; 3、Experienced diarrhea after previous chemotherapy and recovered after treatment; 4、Experienced diarrhea again after this course of chemotherapy; 5、Adequate organ function.

You may not qualify if:

• 、Allergic to foods such as taro, rice, or carrots; 2、Diarrhea after previous chemotherapy not cured; 3、Patients unable to eat orally; 4、Patients with severe mental illness; 5、Patients who cannot cooperate well.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Dr., China

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)