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

Squamous Cell Carcinoma of Esophagus Clinical Trial

— AP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196075
• Other study ID #: CRE-2017.616
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Esophagus

Intervention

Drug:
• Andrographis Paniculata
AP as palliative treatment

Locations

Country	Name	City	State
China	Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong	Hong Kong	Outside Of US & Canada

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months
Secondary	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	4 months
Secondary	Survival	Median Survival	up to 36 months
Secondary	Adverse events	Rate of adverse events	up to 36 months
Secondary	AP side effects	Side effects related to AP including; Gastrointestinal upset; Nausea and Vomiting; Allergy; Diarrhoea; Abdominal pain; Dizziness	4 months