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

Phase 3

Completed

• Conditions: Squamous Cell Carcinoma of Esophagus
• Interventions: Drug: Andrographis Paniculata

• Registration Number: NCT04196075
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Primary Completion: 2021-02-28
• Study Completion: 2021-06-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Andrographis Paniculata treatment	Andrographis Paniculata	Single lot of Andrographis paniculata (AP) concentrated granules (Andrographis Herba) will be manufactured by Nong's Company Limited under GMP standard

Primary Outcome Measures

Name	Time	Method
Symptomatic relief and quality of life after AP	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

Secondary Outcome Measures

Name	Time	Method
Survival	up to 36 months	Median Survival
Difficulty to swallow	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
Adverse events	up to 36 months	Rate of adverse events
AP side effects	4 months	Side effects related to AP including; 1. Gastrointestinal upset; 2. Nausea and Vomiting; 3. Allergy; 4. Diarrhoea; 5. Abdominal pain; 6. Dizziness

Trial Locations

Locations (1)

Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong; 🇨🇳 Hong Kong, Outside Of US & Canada, China