Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2023

“Clinical validation of synergistic effect of Vardhamana Pippali Rasayana along withconventional treatment after unraveling its complex molecular mechanism of action inBreast cancer: From Experimental model to Clinical trial”. (#508)

Subhash Gupta 1 , Richa Tripathy 2 , Vittal Huddar 2 , Haresh KP 1 , Goura K Rath 1 , Tanuja Nesari 2 , Shivam Singh 1 , PRANAY TANWAR 1 , Ashok Sharma 1 , Omana Nair 1 , Sandeep Mathur 1 , Suman Bhasker 1 , Ravi Mehrotra 3
  1. AIIMS NEW DELHI, New Delhi, -- DELHI, India
  2. AIIA, DELHI, India
  3. ICMR, DELHI, India

Background: As per the National Cancer Registry program of the Indian Council of Medical Research (ICMR), Breast cancer (BC) is the leading cause of cancer-related deaths among women in India. There is a need to develop the integration therapy, due to the high tumor recurrence rate, regression, and disease progression. Vardhamana Pippali Rasayana (VPR) is time tested medication by Ayurveda practitioners and is proven to be anti-cancerous, anti-proliferative, and inhibit the survival of cancer cells. However, its anti-cancer role in breast cancer is yet to be elucidated. The cytotoxic effects of Piper longum (Pippali) aqueous extract on human breast cancer cell line (MCF7) using various in-vitro assays have been discussed in our first abstract. The aim of the present study is to design a study for clinical validation of VPR in breast cancer patients.

Methods: In this exploratory study, 100 breast cancer patients (Stage-II-IVA) undergoing neo-adjuvant chemotherapy (NACT) will be randomly divided into two groups. Control group A (Observational Arm, n=50) will receive only NACT (Neo-adjuvant chemotherapy) and Study group B (Trial Arm, n=50), in which NACT+VPR will be administered. All the patients will be recruited from the IRCH, AIIMS, New Delhi, India. Approval will be taken by the research and ethics committee of IRCH, AIIMS, New Delhi, India and from AIIA, New Delhi. For clinical synergistic validation of VPR, the recruitment of patients with breast cancer has also been initiated (flow chart attached at the end).

Expected Outcome: The expected primary outcome from the validation of the synergistic role of VPR Intervention with neo-adjuvant chemotherapy of BC is to evaluate the Pathological complete response (PCR) rates, and the secondary outcome is Progression-free survival (PFS) or recurrence-free survival (RFS) and Overall survival benefits.

Novelty: VPR is considered to have strong anti-cancerous therapeutic potential and exploration of VPR interactions might be offering a novel opportunity for meaningful therapeutic interventions in BC.