Concentrated Complex Plant Dietary Elements for Chemotherapy-Induced Diarrhea

March 5, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
clinical cure rate of diarrhea
Time Frame: 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.
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
Time Frame: 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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