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Completed

NCT Number: NCT04196075

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Andrographis Paniculata

Drug

AP as palliative treatment

Primary outcomes

  1. 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

Secondary outcomes

  1. Difficulty to swallow

    Time frame: 4 months

    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

  2. Survival

    Time frame: up to 36 months

    Median Survival

  3. Adverse events

    Time frame: up to 36 months

    Rate of adverse events

  4. AP side effects

    Time frame: 4 months

    Side effects related to AP including

    • Gastrointestinal upset
    • Nausea and Vomiting
    • Allergy
    • Diarrhoea
    • Abdominal pain
    • Dizziness

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Acronym: AP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2019
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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