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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change in total EORTC H&N35, EORTC H&N43, FACT-HN score in both treatment arms
研究概览
简要总结
Rationale/Gaps in Existing Knowledge
Head and Neck Cancer (HNC) is a major public health concern in India, with late-stage presentation and poor survival rates. Conventional treatments (radiotherapy, surgery) are effective but cause debilitating side effects, negatively impacting patients’ Health-Related Quality of Life (HR-QoL). Patients seek complementary and alternative medicine (CAM) to manage these side effects, but its safety and efficacy with conventional treatment is unclear.
Novelty
The present study examines the integrative oncology approach by incorporating Comprehensive Ayurveda Treatment (CAT) as add-on with conventional HNC treatment in Central India. CAT, a holistic system, presents a novel and cost-effective array of therapies, including panchgavya, triphala, yoga etc. with potential applications in the management of HNCs.
Objectives
To compare the effectiveness of add-on CAT therapies with standard care versus only standard care in unresectable stage III – IVB head-neck squamous cell carcinoma (HNSCC) patients, w.r.t. health-related quality-of-life (HR-QoL) (primary), expression of biochemical and epigenetic markers, psychological distress, and its safety (secondary).
Methods
This study is an Assessor blind Open labelled Parallel group Randomized Controlled Trial, conducted at tertiary care centre. Total of 100 cases (50 in each arm) of unresectable histologically proven stage III - IVB HNCs will be recruited after a comprehensive screening process as per inclusion and exclusion criteria: involving haematological, radiographic etc. assessments for final inclusion and staging. They will be stratified: control arm receiving standard treatment with Concomitant Chemoradiotherapy (CRT) with modern volumetric arc modulated radiotherapy (VMAT) and trial arm receiving CAT therapies as add-on to standard treatment. Regular evaluations by clinicians and Ayurvedic experts will occur periodically, including physical examinations and relevant investigations (radiological, cytokines, epigenetic markers etc.) to monitor treatment progress and outcomes (QoL, Psychological distress, safety and efficacy).
Expected Outcomes
1) Improved patient QoL and symptom management in HNC
2) Evaluation of the feasibility, safety, and preliminary efficacy of this integrative paradigm in the clinical context.
Develop evidence-based guidelines for integrating CAT therapies into HNC care, to empower these patients and improve HNC management in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean change in total EORTC H&N35, EORTC H&N43, FACT-HN score in both treatment arms
时间窗: From baseline to 6 months
次要结局
- 1. Mean change in expression of cytokines and epigenetic markers in both arms(2. Mean change in BDI scores)
研究者
Dr Gayatri Muthiyan
All India Institute Of Medical Sciences Nagpur