The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer (AP)

November 5, 2021 updated by: Philip Wai Yan CHIU, Chinese University of Hong Kong
This is a prospective cohort study on the effect of Andrographis Paniculata (AP) on palliative management of patients with advanced or metastatic esophageal cancer. A total of 30 patients with locally advanced or metastatic squamous esophageal cancer will be recruited for the trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

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
    • Outside Of US & Canada
      • Hong Kong, Outside Of US & Canada, China, 00000
        • Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged over 18
  2. Locally advanced esophageal cancer with invasion or adherent to surrounding organs including trachea, recurrent laryngeal nerves and descending aorta;
  3. Presence of distant metastasis;
  4. Extensive lymph node metastasis to beyond surgical therapy

Exclusion Criteria:

  1. Patients who cannot receive palliative stenting for dysphagia or under other conventional treatment including chemotherapy or chemoradiotherapy
  2. Patients who are not willing to receive Chinese herbal medicines
  3. Patients who do not consent for the study

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
Intervention / Treatment
Experimental: Andrographis Paniculata treatment
Single lot of Andrographis paniculata (AP) concentrated granules (Andrographis Herba) will be manufactured by Nong's Company Limited under GMP standard
Drug: Andrographis Paniculata
AP as palliative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic relief and quality of life after AP
Time Frame: 4 months
Symptomatic relief of Dysphagia and quality of life after treatment Dysphagia measured by Dysphagia score Quality of Life measured by EORTC-QLQ-C30
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulty to swallow
Time Frame: 4 months

Difficulty to swallow by dysphagia grade 0 = able to eat normal diet / no dysphagia.

  1. = able to swallow some solid foods
  2. = able to swallow only semi solid foods
  3. = able to swallow liquids only
  4. = unable to swallow anything / total dysphagia
4 months
Survival
Time Frame: up to 36 months
Median Survival
up to 36 months
Adverse events
Time Frame: up to 36 months
Rate of adverse events
up to 36 months
AP side effects
Time Frame: 4 months

Side effects related to AP including

  1. Gastrointestinal upset
  2. Nausea and Vomiting
  3. Allergy
  4. Diarrhoea
  5. Abdominal pain
  6. Dizziness
4 months

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

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)

March 1, 2018

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2017.616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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