Back to resultsThe Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer (AP)
Primary Purpose
Squamous Cell Carcinoma of Esophagus
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Andrographis Paniculata
Sponsored by
About this trial
This is an interventional supportive care trial for Squamous Cell Carcinoma of Esophagus
Eligibility Criteria
Inclusion Criteria:
- Aged over 18
- Locally advanced esophageal cancer with invasion or adherent to surrounding organs including trachea, recurrent laryngeal nerves and descending aorta;
- Presence of distant metastasis;
- Extensive lymph node metastasis to beyond surgical therapy
Exclusion Criteria:
- Patients who cannot receive palliative stenting for dysphagia or under other conventional treatment including chemotherapy or chemoradiotherapy
- Patients who are not willing to receive Chinese herbal medicines
- Patients who do not consent for the study
Sites / Locations
- Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Andrographis Paniculata treatment
Arm Description
Single lot of Andrographis paniculata (AP) concentrated granules (Andrographis Herba) will be manufactured by Nong's Company Limited under GMP standard
Outcomes
Primary Outcome Measures
Symptomatic relief and quality of life after AP
Symptomatic relief of Dysphagia and quality of life after treatment Dysphagia measured by Dysphagia score Quality of Life measured by EORTC-QLQ-C30
Secondary Outcome Measures
Difficulty to swallow
Difficulty to swallow by dysphagia grade 0 = able to eat normal diet / no dysphagia.
= able to swallow some solid foods
= able to swallow only semi solid foods
= able to swallow liquids only
= unable to swallow anything / total dysphagia
Survival
Median Survival
Adverse events
Rate of adverse events
AP side effects
Side effects related to AP including
Gastrointestinal upset
Nausea and Vomiting
Allergy
Diarrhoea
Abdominal pain
Dizziness
Full Information
NCT ID
NCT04196075
First Posted
December 10, 2019
Last Updated
November 5, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04196075
Brief Title
The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer
Acronym
AP
Official Title
The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Esophagus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Andrographis Paniculata treatment
Arm Type
Experimental
Arm Description
Single lot of Andrographis paniculata (AP) concentrated granules (Andrographis Herba) will be manufactured by Nong's Company Limited under GMP standard
Intervention Type
Drug
Intervention Name(s)
Andrographis Paniculata
Intervention Description
AP as palliative treatment
Primary Outcome Measure Information:
Title
Symptomatic relief and quality of life after AP
Description
Symptomatic relief of Dysphagia and quality of life after treatment Dysphagia measured by Dysphagia score Quality of Life measured by EORTC-QLQ-C30
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Difficulty to swallow
Description
Difficulty to swallow by dysphagia grade 0 = able to eat normal diet / no dysphagia.
= able to swallow some solid foods
= able to swallow only semi solid foods
= able to swallow liquids only
= unable to swallow anything / total dysphagia
Time Frame
4 months
Title
Survival
Description
Median Survival
Time Frame
up to 36 months
Title
Adverse events
Description
Rate of adverse events
Time Frame
up to 36 months
Title
AP side effects
Description
Side effects related to AP including
Gastrointestinal upset
Nausea and Vomiting
Allergy
Diarrhoea
Abdominal pain
Dizziness
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged over 18
Locally advanced esophageal cancer with invasion or adherent to surrounding organs including trachea, recurrent laryngeal nerves and descending aorta;
Presence of distant metastasis;
Extensive lymph node metastasis to beyond surgical therapy
Exclusion Criteria:
Patients who cannot receive palliative stenting for dysphagia or under other conventional treatment including chemotherapy or chemoradiotherapy
Patients who are not willing to receive Chinese herbal medicines
Patients who do not consent for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
City
Hong Kong
State/Province
Outside Of US & Canada
ZIP/Postal Code
00000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer
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