A Prospective Observational Cohort Study on Clinical Presentation, Ayurvedic Understanding, Patient Intentions, and Treatment outcomes in Hepatobiliary Cancers and A Clinical Pilot study to assess the outcomes of Ayurveda Interventions in Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 117
- 试验地点
- 1
研究概览
简要总结
This is a single-centre, two-phase study conducted at a tertiary-care Ayurveda hospital, AIIA in New Delhi to evaluate the role of Ayurveda in the management of hepatobiliary cancers, including hepatocellular carcinoma, cholangiocarcinoma, and gallbladder cancer.
Part I is a prospective observational cohort study enrolling patients with hepatobiliary cancers who will be followed for six months. The study will document sociodemographic and clinical characteristics, cancer type and stage, prior and concurrent conventional treatments, and detailed Ayurvedic assessments. The primary outcome is change in quality of life, with secondary outcomes including performance status, symptom burden, treatment adherence, and safety.
Part II is a single-arm clinical pilot study involving patients with hepatocellular carcinoma who have declined or are not receiving conventional therapy. Participants will receive protocol-based Ayurvedic interventions for two months. The primary outcome is change in liver functional reserve assessed using the Albumin–Bilirubin score, with secondary outcomes including liver function tests, quality of life, performance status, and safety.
Data will be analyzed using descriptive and paired inferential statistics, with multivariate analyses and principal component analysis to explore associations between multimodal Ayurvedic treatment patterns and clinical outcomes, focusing on feasibility, safety, and effect-size estimation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 10.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •6 Provision of written informed consent prior to participation.
排除标准
- •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.
研究者
Jassim Rahiman K
All India Institute of Ayurveda (AIIA)