Health Condition 1: 8- Other Procedures
Conditions
Interventions
Intervention1: HuMOLYTE electrolyte mix With 2 Fucosyllactose versus standard treatment in subjects going through chemotherapy for solid tumors: Patients involving Solid Tumors 16 will be treated with
Sponsors
IGH NATURALS INC
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Voluntarily participating in the clinical study fully understanding and being fully informed of the study and having signed the Informed Consent Form willingness and capability to complete all the study procedures Age 18 70 years both inclusive at the time of signing ICF Confirmed histological diagnosis of cancer and scheduled to receive 1st dose of chemotherapy Cancer Types Eligible for Inclusion Head and neck oral cancer Solid tumors including breast ovarian colon lung or liver cancer Cohort A Hematological malignancies including leukemia or lymphoma receiving high dose chemotherapy for treatment of primary disease or for preparation of bone marrow transplantation Cohort B Patients at a high risk of developing a minimum of 02 grade in WHO Mucositis Scale 1979 Subject willing and able to understand and comply with the requirements of the study Not participating in any other interventional drug clinical studies before completion of the present study
Exclusion criteria
Exclusion criteria: Patients who have already begun chemotherapy Known hypersensitivity reaction to any ingredient of the formulation or its active ingredients Unstable patients with infections or heart failure Use of any recreational drugs or history of drug addiction Uncontrolled hypertension at screening visit Females who are pregnant breastfeeding or planning a pregnancy Significant heart lung or liver disease HIV or hepatitis infections or those deemed unstable by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of severity and extent of oral sores on Prior to Day -04 end of week 01 02 03 and 04 based on WHO scale Assessment of gastrointestinal symptoms nausea vomiting diarrhea on Prior to Day -04 end of week 01 02 03 and 04 using a Gastrointestinal GIS score Change in the Quality of Life of patients Wellbeing index score before and after the treatmentTimepoint: Baseline Day -04 Week 01 Week 02 Week 03 Week 04 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Serum electrolytes sodium potassium & magnesium Blood Urea Nitrogen BUN and creatinine C reactive protein Complete Blood Count CBC AST ALT and Serum albumin on Prior to Day -04, end of week 01 02 and 04 Gut injury marker Quantitative fecal calprotectin level on Prior to Day -04 and end of week 02 Overall reduction in the Adverse events and Patient compliance for the new treatmentTimepoint: Baseline Day -04 Week 01 Week 02 Week 03 Week 04 | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed