Concentrated Complex Plant Dietary Elements for Chemotherapy-Induced Diarrhea

Concentrated Complex Plant Dietary Elements for Chemotherapy-Induced Diarrhea: a Phase II Open-label, Single-arm Study

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.

Study Overview

• Status: Completed
• Conditions: Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma; Colon and Rectal Cancer
• Intervention / Treatment: Dietary supplement: Concentrated Phytodietary Compound

Detailed Description

Gastrointestinal cancer ranks high in both incidence and mortality, as one of the major health threats worldwide. Chemotherapy with or without surgery is the first line of treatment for gastrointestinal cancer. Chemotherapy involves the use of powerful cytotoxic drugs to stop tumor growth by targeting rapidly dividing cells through various mechanisms, and has greatly improved overall survival of patients. Simultaneously, chemotherapy often affects rapidly dividing gastrointestinal epithelial cells, leading to gastrointestinal symptoms, and diarrhea is a common adverse reaction in cancer patients receiving various chemotherapy regimens, particularly those containing antimetabolites (e.g., 5-fluorouracil (5-FU), capecitabine), topoisomerase inhibitors (e.g., irinotecan, topotecan), platinum analogs (e.g., oxaliplatin), monoclonal antibodies (e.g., cetuximab, panitumumab), and tyrosine-kinase inhibitors (e.g., sorafenib). During chemotherapy-induced diarrhea (CID), patients may suffer from fatigue, dehydration, electrolyte imbalance, malnutrition, psychological stress, and significant disruption of daily life, as well as abdominal, rectal, and perianal symptoms including pain, excoriation, and discomfort. In addition, severe CID may impair therapy outcomes and increase mortality due to dose delays and reductions and/or interruption.

Severity of CID has been associated with several specific chemotherapeutic regimens, among which regimens involving topoisomerase inhibitors (irinotecan, topotecan) and antimetabolites (5-FU, capecitabine) are associated with a higher incidence of CID than other types [11]. It is estimated that 50%-80% of patients receiving irinotecan and/or 5-FU chemotherapy develop CID due to inflammation and ulceration in the intestine and changes in the intestinal microbiota; if not addressed, CID can become life-threatening, as it may lead to severe dehydration and sepsis. Historically, clinical practice guidelines from the European Society of Medical Oncology (ESMO) and Chinese Society of Clinical Oncology (CSCO) have recommended stratified treatment based on diarrhea grading under the basic care of dietary adjustment and fluid replacement. For grade 1 diarrhea, observation and dietary adjustment are provided. For grade 2 diarrhea, standard antidiarrheal agents (such as loperamide) are administered for management. For grade 3 and 4 diarrhea, the suspected chemotherapeutic drugs should be discontinued immediately, and active management includes intravenous administration of octreotide and antibiotics. Even with these options, many patients still have unmet needs, especially in severe diarrhea. Notably, nutritional adjuvants, which encompass dietary counseling, food supplements, and medical nutrition therapy, may not only address nutritional needs but also alleviate or reverse CID.

Nutritional adjuvants are an important part of supportive care. It includes diet counseling, oral supplements, and medical nutrition therapy. Studies have shown that probiotics administration, traditional herbal medicine supplementation, a Mediterranean Modified Healthy Diet, and avoidance or limitation of spicy, fatty, or dairy products could effectively reduce CID. However, the evidence remains insufficient. Many strategies are hard to follow in daily life, and adherence is often low. In addition, few studies provide a simple and culturally acceptable food-based option for Chinese patients during active chemotherapy.

The concentrated phytodietary compound (CPC) is a food-based supplement, whose ingredients are natural foods beneficial for diarrhea treatment, including taro, carrot, glutinous rice, and rice, all of which are consistent with the omnivorous dietary habits of the Chinese population. This study aims to evaluate CPC as a nutritional adjunct to routine CID treatment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Dr.
    • Tianjin, Dr., China
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1、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.

Exclusion Criteria：

1、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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1	Dietary supplement: Concentrated Phytodietary Compound; All patients received routine anti-diarrheal treatment plus Concentrated Phytodietary Compound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Rectal Neoplasms; Esophageal Neoplasms
• Other Study ID Numbers: TJMUCH-GI-ST02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No