Ayurvedic intervention in breast cancer patients reduces adverse effects of chemotherapy, modulates systemic immune response and improves quality of life: A non-randomised controlled study (Preprint)
Authors: Deshmukh Vineeta , Sardeshmukh Sadanand , Patil Tushar , Nagarkar Raj , Gujar Shweta , Pathak Shridevi , Deshpande Dhananjay , Awalkanthe Vinita , Awalkanthe Sanjog , Paleja Nishtha , Kate Shruti , Patil Padmaja , Shivgankar Sushama , Godse Vasanti , Kulkarni Swapna , Sardeshmukh Nilambari , Karade Devidas , Gota Vikram , Gupta Vidya , Bendale Kajal , Gandhi Khushaboo , Chavan Sandeep 
Published: October 2024

BACKGROUND

65-97% of cancer patients experience one or more chemotherapy-induced adverse effects, which hampers the quality of life (QoL) of cancer patients. One of the studies carried out at our centre regarding the use of adjunct Ayurvedic medicine in alleviating the chemotherapy adverse effects showed significant improvement in lessening the adverse effects and improving QoL.

OBJECTIVE

To assess the efficacy of combinations of Ayurvedic drugs in alleviating the toxicity of chemotherapy, and improving systemic immune response and QoL of breast cancer (BC) patients.

METHODS

Participants: A total of 135 BC patients undergoing chemotherapy were screened in this study. Among them, 120 patients were included in the study. The Study group (n=63) completed the chemotherapy with Oral Ayurvedic Medicines (OAM) while the Control group (n=57) received no OAM.
Intervention: The Study group received OAM in the form of herbo-mineral metallic formulations for 10 months, initiating at the start of chemotherapy. The Control group received no OAM along with chemotherapy. Both groups were followed for 4 years.

Outcome measures: All the patients were assessed for adverse effects based on Common Terminology Criteria (designed by the National Institute of Health-National Cancer Institute), physical examination including Karnofsky performance score and QoL Questionnaire C-30 and BR-23 (designed by European Organisation for Research and Treatment of Cancer). Additionally, complete blood count, liver function test, kidney function test, inflammatory and tumour markers, cytokines and oxidative stress markers were also evaluated at definite time points.

RESULTS

The standardized and OAM tests for chronic toxicity ensured quality and safety. Study subjects experienced significant improvements in side effects such as anorexia, nausea, mucositis, and fatigue (p<0.01). Clinical haematological and biochemical parameters within normal limits suggested the protective effects of OAM on vital organs like the liver and kidneys during chemotherapy drug metabolism. CRP levels, cytokine markers, and oxidative stress markers partially responded during chemotherapy. Notably, 65% of patients in the study group could complete chemotherapy without delays, compared to 37% in the control group. The survival analysis at the end of 4 years showed no significant difference between the two groups, indicating non-interference of OAM in the efficacy of chemotherapy drugs but a better quality of life in breast cancer patients taking OAM.

CONCLUSIONS

OAM appeared to be safe and effective in reducing the toxic adverse effects of chemotherapy drugs in breast cancer patients, if administered simultaneously with chemotherapy for the short-term and continued after completion of conventional treatment for long-term adverse effects. No statistical difference in the survival pattern after four years signifies no adverse interaction with chemotherapeutic drugs used as a conventional treatment for cancer.

CLINICALTRIAL

CTRI/2017/01/007687