Health Condition 1: C810- Nodular lymphocyte predominant Hodgkin lymphoma
Conditions
Interventions
Intervention1: Different herbs in powder form: Gymnema Sylvestre
Azadiracta Indica
Citrullus colocynthis
Berberis aristata
Tribulus terrestris
Withania somnifera
Simarouba glauca
Ocimum tenuiflorum
Sponsors
Dr Sukhjindar Singh Ghotra
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed and dated Independent Ethics Committee (IEC)-approved written informed consent. 2. Age >=13 years and 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 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
Exclusion criteria
Exclusion criteria: 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 (Any woman becoming pregnant during the study will be withdrawn from the study.) 7.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before the start of chemotherapy. 8.Active cardiac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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Anthropometric factors Weight, BMI- Weight loss alteration -(Monthly weight record) 2.Chemotherapy Induced Nausea & Vomiting (CINV)- (Monthly grading will be done according to the CTCAE grade system) 3.Incidence of mucositis - (Monthly assessment will be done) Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 4.Nutrient intakes (Macronutrient) assessment using FFQ/24-hour recall 5.CR rate (Cancer Remission) 6.Metabolic factor/ Biochemical- (whenever test done) 7.Quality of life and participant satisfactionTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Sukhjindar Singh Ghotra
Postgraduate Institute of Medical Education & Research
Outcome results
None listed