A Personalized Rasayana therapy to improve quality of life
- Conditions
- Health Condition 1: C15-C26- Malignant neoplasms of digestive organs
- Registration Number
- CTRI/2020/10/028281
- Lead Sponsor
- Rasayu Cancer Clinic Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Histopathologically diagnosed Patients with gastrointestinal cancer which includes stomach colorectal pancreas esophagus Liver cancers etc
2 Male and Female patient above the age of 60 years
3 Patients who are ineligible to receive conventional anticancer therapy
4 Patients for whom no conventional anticancer therapy exist
5 Those that are willingly refusing conventional anticancer therapy with the reason known
6 Patients having resistance to conventional therapies like chemotherapy,immunotherapy etc
7.Patients who are willing to take exclusively Rasayana therapy
1 Patients taking any other conventional or alternative treatment which is known to significantly impact Patients Quality of life
2 Patients receiving any conventional anticancer therapy
3 Patients with any psychiatric disturbance major depression psychosis which will impair Patients ability to respond the questions in QoL questionnaire
4 Patients with cerebral mets
5 Patients with taking analgesics
6 Patients with expected survival of less than 3 months
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br/ ><br>To evaluate the efficacy of Rasayana therapy in improving health related QoL , Physical performance status and identify its impact on survivalTimepoint: Pre and post therapy- monthly Quality of life and physical performance status will be assessed by FACT G scale and ECOG measuring tool upto 3 months and patient will be observed for overall survival further upto 1 or more than 1 year <br/ ><br>
- Secondary Outcome Measures
Name Time Method To evaluate the Safety and tolerability of Rasayana therapy <br/ ><br> <br/ ><br>To evaluate impact of Rasayana therapy on gastrointestinal tumorsTimepoint: Safety will be assessed at baseline and bimonthly with heamatological and biochemical parameters and by CTCAE V 5 criteria <br/ ><br> <br/ ><br>Tumour response will be assessed by Radiological assessment with PET-CT scan at baseline and post therapy at 6 months