A randomized controlled trial to study the adjunctive role of combo herbal supplement powder in reducing the chemotherapy associated toxicity in patients undergoing treatment for NON-HODGKIN LYMPHOMA

Dr Sukhjindar Singh Ghotra0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

试验速览

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•1.Signed and dated Independent Ethics Committee (IEC)-approved written informed consent.
•2.Age >=13 years and <=60 years.
•3.Histological documentation of aggressive B cell NHL.
•4.Planned to receive systemic anticancer therapy with at least 4 cycles of R-CHOP-21, according to local standards.
•5.ECOG score <=2.
•6.Life expectancy of at least 3 months.
•7.Adequate bone marrow, renal and hepatic function to be normal within 14 days before start of chemotherapy.
•8.The patient is capable of understanding and complying with parameters as outlined in the protocol.
•9.Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment and for 30 days after discontinuation of study drug.
•10.The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the treatment (and for 90 days after taking the last dose of study.
•11.Able to read
•12.Have personal mobile phone/ Access to a telephone

•1 Any preexisting condition/contraindications (abnormal creatinine levels, liver dysfunction).
•2 Bedridden patients and patients due for operations
•3 Enrolled in other active intervention research studies.
•4.Participation in a clinical study within 30 days before randomization.
•5. Any chemotherapy within the last 3 months before the start of chemotherapy. A paraphrase to reduce tumor burden prior to the start of R-CHOP is allowed.
•6.The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
•7.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before the start of chemotherapy.
•8.Active cardiac disease
•9.Arterial or venous thrombotic or embolic events such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 6 months before the start of chemotherapy.
•10.Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C.
•11.Patients with evidence or history of bleeding diathesis
•12.Non-healing wound, ulcer, or bone fracture

发起方

Dr Sukhjindar Singh Ghotra