A Study to Compare Add on Ayurvedic Treatment Versus Only Conventional Care in Modern Medicine to Improve Quality of Life for Advanced Head and Neck Cancer Patients

Efficacy of Comprehensive Ayurvedic Treatment (CAT) as Add-On to Conventional Bio-Medicine in Improving the Quality of Life (Qol) in Unresectable Stage III-IVB Head-Neck Squamous Cell Carcinoma (HNSCC) Patients: An Assessor Blind Randomized Controlled Trial, CATCH Trial - CATCH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083336

Enrollment

100

Registered

2025-03-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 2: C01- Malignant neoplasm of base of tongue Health Condition 3: C13- Malignant neoplasm of hypopharynx

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) Unresectable histologically proven Head and Neck Squamous cell carcinoma patients, 2) Head and neck cancer with stage III to IVB 3) Age group of 18 to 70 years 4) Eastern Co operative Oncology Group ECOG performance status grade 0 to 1, 5) Haematological profile Haemoglobin level greater than 10 mg per dl, Total Leukocyte count greater than 4000 per mm3, platelet count greater than 100000 per mm3, adequate serum creatinine 0.6 to 1.5 mg per dl, ALT 0 to 45 U per L 6) Normal electrocardiogram

Exclusion criteria

Exclusion criteria: 1) Those who are not willing to give consent 2) Carcinoma of nasopharynx, nasal cavity and paranasal sinuses 3) Patients with prior history of cancer, or synchronous malignancy 4) Prior history of lactose intolerance, enrolment in other trial or use of ayurvedic medicines

Design outcomes

Primary

Measure	Time frame
Mean change in total EORTC H&N35, EORTC H&N43, FACT-HN score in both treatment armsTimepoint: From baseline to 6 months	—

Secondary

Measure	Time frame
1. Mean change in expression of cytokines and epigenetic markers in both arms 2. Mean change in BDI scores 3. Frequency of adverse drug reactions reported with integrated Ayurveda care 4. Percentage compliance for add-on CAT therapiesTimepoint: From baseline to 6 months	—

Countries

India

Contacts

Public ContactDr Amit Nakanekar

All India Institute Of Medical Sciences Nagpur

gayatrimuthiyan@aiimsnagpur.edu.in9322870196

Outcome results