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

NCT04196075 | Completed Phase 3 DMC

• 1 other identifier: CRE-2017.616
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma of Esophagus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Difficulty to swallow

  4 months

• Survival

  up to 36 months

• Adverse events

  up to 36 months

• AP side effects

  4 months

Study Arms (1)

Andrographis Paniculata treatment

EXPERIMENTAL

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

Drug: Andrographis Paniculata

Interventions

Andrographis Paniculata DRUG

AP as palliative treatment

Andrographis Paniculata treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong

Hong Kong, Outside of US & Canada, 00000, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Andrographis paniculata extract

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Philip WY Chiu, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: March 1, 2018
• Primary Completion: February 28, 2021
• Study Completion: June 30, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

CN (1)