Add-on effect of homeopathy to institutional management protocol in the management of Stage III/IV (unresectable) gallbladder cancer patients: A single-blind randomized controlled pilot study protocol
Year: 2025
Type: article
Study design: Study Protocol
Abstract: Introduction: Gallbladder cancer (GBC) is an aggressive malignancy with poor prognosis and limited treatment options, especially in Stage III/IV unresectable disease. In India, it predominantly affects women from the North and Northeast, with survival rarely exceeding 6–9 months despite standard care. Homeopathy, widely practiced across India, has shown potential in improving quality of life (QOL) and survival in various cancers when used adjunctively, but evidence in GBC remains scarce. Materials and Methods: This single-blind, randomized, placebo-controlled pilot trial will recruit 30 patients with unresectable GBC at Atal Bihari Vajpayee Regional Cancer Center, Agartala. All participants will be randomized (1:1) to receive either the institutional management protocol (IMP) plus individualized homeopathic medicines or IMP plus placebo for 12 months. The primary outcome is overall survival, assessed monthly over 12 months. Secondary outcomes include tumor response (revised RECIST), QOL (FACT-G questionnaire), performance status (Eastern Cooperative Oncology Group scale), and adverse events (CTCAE v5.0). Data were analyzed on an intention-to-treat basis using Kaplan–Meier survival analysis and log-rank tests, with P < 0.05 considered statistically significant. Results: As a pilot trial, the results will emphasize the feasibility, recruitment, adherence, safety, and preliminary efficacy data of adjunctive homeopathic medicines. Conclusion: This study will explore the feasibility, safety, and potential efficacy of individualized homeopathic medicines as an adjunct to standard care in unresectable GBC. Findings may provide a foundation for larger, definitive randomized controlled trials evaluating homeopathy in advanced GBC management. Trial Registration: CTRI/2025/02/080420.
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7117651487