Squamous Cell Carcinoma of Esophagus
Conditions
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.
Interventions
AP as palliative treatment
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Survival | up to 36 months | Median Survival |
| 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 |
Countries
China
Outcome results
None listed