Health Condition 1: C50-C50- Malignant neoplasms of breast Health Condition 2: C15-C26- Malignant neoplasms of digestive organs Health Condition 3: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Lactoferrin: a dose of 100 mg twice (BD) daily will be administered to the patients orally for the period of 3 months
Control Intervention1: Placebo: a dose of placebo will be administe
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with the age more than 18 years and who can give informed consent for the study. 2.Histologically or radiologically confirmed diagnosis of cancer. 3.ECOG performance-status score of 0 to 2. 4.Hemoglobin less than 10, Serum Ferritin more than than normal and Iron sat less than or equal to 20 % 5.Adequate organ function based on biochemistry Liver functions bilirubin les than or equal to 2 times into upper limit normal (ULN),AST/ALT/ALP less than 2.5 times into ULN,S.albumin more than equal to 30 g/L. Renal function Creatinine less than or equal to 1.5 ULN, Creatinine clearance more than 50 mL per min. 6.Women of childbearing age should have a negative pregnancy test at the time of enrollment and should be willing to use adequate contraception during the treatment phase of the trial. 7.No clinical or radiological evidence of infection/sepsis.
Exclusion criteria
Exclusion criteria: 1.History of blood transfusion prior to 15 days of randomization. 2.Allergic to the study medicine. 3.Patients with lactose intolerance. 4.Patients with brain metastasis. 5.Serious comorbidities such as, but not limited to severe cardiac failure severe pulmonary compromise or severe and active infections. 6.Patients on other investigational drugs within the last 30 days. 7.Patients with inability to swallow oral medications. 8.The patient has a history active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure , or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may impair swallowing or capability of oral intake of tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the improvement in grades of anemia (grade 2 or grade 3 anemia ) with increase in Hb by at least 1 gm/dl after administration of Lactoferrin diSodium GMP from baseline counts as a response to therapy. 2.The primary efficacy will be defined as the change in Hb from baseline.Timepoint: The time at which increase the HB will be observed during treatment of 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety & efficacy of Oral Lactoferrin dGMP Supplementation along with chemotherapy & To assess the need for admissions & blood transfusions related to the drop in Hb.Timepoint: Anytime at which drop in Hb is observed. | — |
Countries
India
Contacts
Public ContactDr Vikas Ostwal
Tata Memorial Hospital
Outcome results
None listed