A Randomized, Open Labeled, Single Center, Parallel Group, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of â??RV CAPSâ?? in Comparison with Grape Seed Capsule in Preventing Recurrence of Cancer in Patients Who Have Undergone Surgery for Cancer - NI

RV Newvisions Healthcare Pvt Ltd0 个研究点目标入组 120 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.History of stage 0-II cancer with primary curative resection of the tumour (R0) within last 1 year,
•2.Male and female patients are required to be > 18 years and <70 years of age,
•3.No evidence of recurrent disease since completion of initial treatment confirmed within last 1 year prior to randomization,
•4.Patient with preoperative Neo-Adjuvant Chemo Therapy (NACT) or radiation therapy,
•5.Patient who has an ECOG (Eastern Co-operative Oncology Group) performance status of 0-1,
•6.Patient with
•i.Adequate bone marrow function (Leucocytes > 4,000 per mm3, Platelets > 100,000 per mm3),
•ii.Adequate liver function (Bilirubin < 1.5 mg/dl),
•iii.Adequate renal function (Creatinine < 1.5 mg/dl),
•7.Patient with PET/CT scan showing no evidence of recurrence,
•8.Patient with USG (whole abdomen, pelvis and chest) of showing no evidence of tumour,
•9.Patient able to swallow oral medications,
•10. Patient of low risk or moderate risk of cardiovascular events,
•11. Patient who was not participated in any other clinical trial within last one month and who will not participated in any other clinical trial during the study period,
•12. Patient who is fully informed of the both investigational products,
•13. Patient willing to give his/her written informed consent for study participation and come for follow-up visits.

•1.Patient who has serious or uncontrolled concurrent medical illness, and other active malignancy,
•2.Patient who has advised post-operative radiation therapy or chemotherapy,
•3.Patient having history of organ transplant,
•4.Patient who has history of immunosuppressive therapy in last 1 month period form screening visit,
•5.Patient who has been taking opoid analgesics except tramadol for pain management,
•6.Patient is having pregnancy (in case of female patient),
•7.Women/men of reproductive potential must agree to use effective contraception till the end of study,
•8.History of colon resection > 40 cm,
•9.High cardiovascular risk, uncontrolled hypertension and diabetes mellitus
•10.Documented history of gastric/duodenal ulcer within last 12 months and/or current treatment or active symptoms of gastric/duodenal ulcer
•11.Patient having dependency for any drug
•12.Significant medical or psychiatric condition that would preclude study completion,
•13.Basal cell or squamous cell skin cancer,
•14.Patient operated for Glioma,
•15.History of HIV infection
•16.Subject undergoing renal dialysis,
•17.Uncontrolled ascites (defined as not easily controlled with diuretic treatment),
•18.Encephalopathy.

发起方

RV Newvisions Healthcare Pvt Ltd