A Clinical trial of RV CAPS in Comparison with Grape Seed Capsule in Preventing Recurrence of Cancer.

Phase 2

Recruiting

• Conditions: Prevention of cancer following surgery

• Registration Number: CTRI/2014/02/004371
• Lead Sponsor: RV Newvisions Healthcare Pvt Ltd

Brief Summary

This study is an open label, randomized, comparative, parallel group, single center, prospective, interventional, clinical study to evaluate efficacy and safety of ‘RV CAPS’ in comparison with ‘Grape Seed Capsule’ in preventing recurrence of cancer in patients who have undergone surgery for cancer. The study will be conducted in 120 subjects of having history of stage 0-II cancer with primary curative resection of the tumour (R0) and with no evidence of recurrence within last 1 year. The study will be conducted at Lokmanya Medical Research Centre and Lokmanya Hospital, Chinchwad Pune. The primary outcome will be to evaluate the efficacy of ‘RV CAPS’ in comparison with ‘Grape Seed Capsule’ by assessing the disease (recurrence) free survival of subject for three years. Subjects will be called at study site for 3 monthly follow-up including Screening visit (day -7), and baseline visit (Day 0) i.e. 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, Visit 24 month, 27 month, 30 month, 33 month and 36 month.The secondary objectives will be to evaluate the efficacy and safety of RV CAPS in comparison with Grape Seed capsule in prevention of recurrence of cancer by assessing specific tumor biomarker level (3 monthly), PET/CT scans (12 monthly), USG (whole abdomen, pelvis and chest) (on 6 month, 18 month, 30 month), Chest X-ray (PA-View) (6 monthly), Eastern Co-operative Oncology Group (ECOG) performance scale (on every follow up visit), clinical signs and symptoms (3 monthly),WHOQOL (3 monthly) and laboratory investigations viz. CBC, Hb%, ESR, LFTs, RFTs, Lipid Profile, Urine R & M, and Blood Sugar Level-Fasting (on screening visit and at the end of the study). Also, drug compliance (on every follow-up visit), treatment acceptability/tolerability by patient and physician, and clinical global evaluation for overall improvement by physician and by the patient himself/herself will be assessed as secondary outcomes [on Day 0 and Visit 12 (36 months)].

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2014-01-18
• Study Start: 2014-01-30

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease (recurrence) Free Survival for Three Years	Day 0, 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, 24 month, 27 month, 30 month, 33 month, 36 month

Secondary Outcome Measures

Name	Time	Method
1.Assessment of specific tumor biomarker level	2.Assessment of cancer recurrence by PET/CT scans.

Trial Locations

Locations (1)

Department of Oncology; 🇮🇳 Pune, MAHARASHTRA, India

Department of Oncology

🇮🇳Pune, MAHARASHTRA, India

Dr Vidyadhar Govind Vaidya

Principal investigator

9822057766

vgvaidya@hotmail.com