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Title
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Randomized controlled trial to assess blockade of voltage gated sodium channels during surgery in operable breast cancer. (VGSC Study) Study design / Type : Phase III randomized trial |
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Principal Investigator
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Dr. Rajendra A Badwe |
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Participating Centres
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Number of participants
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1600 |
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Status
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Recruitment completed & follow up ongoing |
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Synopsis
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Voltage gated sodium channels (VGSC) expressed in non-nervous tissue or non-muscular organs are often associated with metastatic behavior of different cancers. A correlation between sodium transport and oncogenesis has been widely reported in literature. Also, growth and proliferation of mammary adenocarcinoma cells can be inhibited by Amiloride suggesting that epithelial Na channels (ENaC) activity is correlated with proliferation of breast cancer cells. Current evidence suggests that VGSC activity is necessary and sufficient for cancer cell invasiveness.
Surgical operations for cancer have been reported to induce dissemination of cancer cells into surrounding tissues or into the circulation and infiltration anesthetics can inhibit immune response. Although the mechanism remains to be elucidated, infiltration anesthetics such as lidocaine have membrane-stabilizing action (Seeman, 1972) and these agents could have direct effects on cancer cells. Therefore, it is important to clarify the effects of infiltration anesthetics on behavior of the tumor cells. Commonly used local anesthetic agents inhibit the VGSCs and also possess a unique membrane stabilizing action through other unknown mechanisms. The primary objective of the study is to assess the in-vivo ability of local anesthetics agents like lignocaine to decrease the dissemination of cancer cells during surgery and improve the disease free interval & secondary objective to assess the in-vivo ability of local anesthetics agents like lignocaine on impacting long term survival. The study drug will be tested in the intra-operative setting prior to surgery in a randomized setting. The dose of lidocaine will be calculated based upon body weight, limiting to the maximum tolerated dose of 4.5mg/kg. The quantity of 0.5 % of maximum tolerated dose (as per the patient’s body weight) will be distributed such that 1/6th of this solution will be instilled on each of the 6 surfaces of the tumor. The excision will be done after 7 minutes of injection of lignocaine. Arm A: Lignocaine solution (as mentioned above) will be injected peritumoral prior to excision. (Intervention arm) Arm B: No injection of lignocaine prior to excision (Control arm) |
VGSC Study
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