INVESTIGATION OF THE ANTI-NEOPLASTIC EFFECT OF TRISHUL (AYURVEDIC AGENT) ON TUMOUR REGRESSION OF RECTAL CANCER- A PILOT STUDY

Ayurvedic medicines are used extensively in Asia both for benign as well as malignant disease. Despite their widespread use there is scant scientific evidence to prove efficacy. There are anecdotal reports of effectiveness. Patients are often referred to ayurvedic physicians when all other options have been exhausted. We, at the university of Kelaniya , are planning a randomised double blind placebo controlled study to investigate the anticancer effects of an anticancer ayurvedic drug Trishul in patients with rectal cancer. Patients after discussion at the multidisciplinary discussion will be randomised into two groups. One group will receive the active drg and the other will receive matching placebo. This will be additional to the standard treatment advised by the multidisciplinary team. Treatment/Placebo will be started 4 weeks preoperatively and continued for 24 weeks postoperatively. Patients will be followed up in a standard manner. Evidence of any adverse effects, disease recurrence either locally or at a distant site will be recorded. Overall survival and disease free survival will be the primary endpoints.

Sex

All

Minimum age

18 Years

Inclusion Criteria:• Adults aged over18 years, stratified for \<40 vs. \>40 years.

* Histologically confirmed diagnosis of adenocarcinoma of the rectum stratified for grade of tumour of biopsy samples (Grade 1 and 11 vs 111)
* Tumour classified as clinical stage T3-T4 and/or node-positive (N1-N2) without distant metastases (M0), based on MRI or CT.
* Suitable for preoperative chemoradiotherapy and surgical resection.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (See appendix)
* Normal haematological, renal, and hepatic serum biochemistry.
* Ability to provide informed consent.

Exclusion Criteria:• Evidence of distant metastases (M1 disease).

* Prior pelvic radiotherapy, chemotherapy, or Ayurvedic therapy targeting cancer.
* Known allergy or intolerance to medication.
* Inflammatory bowel disease or other significant gastrointestinal disorders.
* Pregnant or breastfeeding women.
* Concurrent participation in another interventional clinical trial.
* Any condition deemed by the investigator to interfere with study participation.