Health Condition 1: C22- Malignant neoplasm of liver and intrahepatic bile ducts
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
All India Institute of Ayurveda (AIIA)
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria PART I OBSERVATIONAL STUDY 1 Participants aged ten years to seventy years. 2 Patients diagnosed with any type of cancer of the hepatobiliary system, including liver, intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of Vater. Cancer site (topography) and type, behavior, and grade (morphology) will be recorded as per ICD-O-3 (International Classification of Diseases for Oncology, Third Edition). 3 ECOG performance status between zero and two. 4 Patients who are receiving or planning to receive Ayurveda-based cancer care at the tertiary care hospital, either before, during or after conventional treatments such as surgery, chemotherapy or radiotherapy. 5 Availability of essential medical records, including histopathology reports, staging details and prior treatment history, to ensure accurate disease classification and enable adjusted analyses. PART II: CLINICAL PILOT STUDY 1 Participants aged 18 years and above. 2 Diagnosed cases of hepatocellular carcinoma. 3 Disease staging as per the Barcelona Clinic Liver Cancer (BCLC) Staging System, including Stage B, Stage C, and Stage D. 4 Patients who have been advised conventional cancer therapies but have declined such treatments after adequate counselling. 5 ECOG performance status between zero and two. 6 Provision of written informed consent prior to participation.
Exclusion criteria
Exclusion criteria: Exclusion Criteria PART I OBSERVATIONAL STUDY 1 Participants who are unable to complete patient reported outcomes due to severe cognitive impairment, psychiatric illness, absence of validated language tools, or critical illness, as per the judgment of the investigator. 2 Anticipated inability to complete six month follow-up (such as relocation, hospice care, logistic barriers). 3 Concurrent enrollment in another interventional study is likely to influence symptom or QoL outcomes. 4 Pregnant or breastfeeding when Ayurveda exposures or procedures may be contraindicated. 5 Patients unwilling or unable to provide informed consent or adhere to follow-up assessments. PART II CLINICAL PILOT STUDY 1 Prior systemic therapy, radiotherapy, or surgery for hepatocellular carcinoma in the last two months. 2 ECOG performance status greater than or equal to three. 3 Severe uncontrolled comorbidities. 4 Pregnant or lactating women. 5 Inability/unwillingness to consent or comply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To document clinical presentation, Ayurvedic understanding, patient intentions to opt for Ayurveda, therapeutic practices, and outcomes through quality-of-life assessment in hepatobiliary cancer patients through FACT-Hep and EORTC QLQ-C30 over six months. 2. To evaluate preliminary clinical outcomes, through protocolized ayurvedic interventions in hepatocellular carcinoma (HCC) through changes in Albumin-Bilirubin (ALBI) score over two months.Timepoint: Observational: Hepatobiliary cohort study Baseline, 2 months, 4 months, 6 months HCC pilot Baseline, 1 month, 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To evaluate the safety, tolerability & patient compliance with Ayurvedic interventions. 2 To observe & document adverse drug reactions or adverse events, if any. 3 To assess the functional status of hepatobiliary cancer patients using the ECOG Performance status. 4 To assess preliminary outcomes of Ayurveda interventions in hepatocellular carcinoma through changes in liver function tests, quality-of-life assessment (EORTC QLQ HCC 18) & ECOG performance status. Timepoint: Observational Hepatobiliary cohort study Baseline, 2 months, 4 months, 6 months HCC pilot Baseline, 1 month, 2 months | — |
Countries
India
Contacts
Public ContactDr V G Huddar
All India Institute of Ayurveda (AIIA)
Outcome results
None listed