None listed
Conditions
Brief summary
Our hypothesis is bovine lactoferrin may increase level of haemoglobin in patients with cachexia related to underlying stage IV non-small cell lung cancer. Our primary object is to compare the level of haemoglobin in comparison with the placebo, after adminstration of 250 my of bovine lactoferrin. The secondary object is the comparison with the placebo ,the effect of two different doses of bovine lactoferrin 250 mg versus 500 mg and will check the effect on increase in serum iron, red blood cell count and haemoglobin concentration. Also to compare the effect of 250 mg of bovine lactoferrin in cancer cachexia versus apparent healthy
Interventions
Oral administration of 250 mg, 500 mg of bovine lactoferrin once daily for 12 weeks
, one arm will receive 250 mg bovine Lactoferrin, one arm will receive 500 mg of bovine Lactoferrin and one arm will receive placebo. and the apparent healthy will receive 250 mg bovine Lactoferrin.
All the group one tablet once dailyParticipants were the same for phase 1 and phase 2.
Phase 1 started on December 2016 and finished in March 2017, we measured Hb, RBCs count and serum iron level.
Second Phase star
Oral administration of 250 mg, 500 mg of bovine lactoferrin once daily for 12 weeks , one arm will receive 250 mg bovine Lactoferrin, one arm will receive 500 mg of bovine Lactoferrin and one arm will receive placebo. and the apparent healthy will receive 250 mg bovine Lactoferrin. All the group one tablet once dailyParticipants were the same for phase 1 and phase 2. Phase 1 started on December 2016 and finished in March 2017, we measured Hb, RBCs count and serum iron level. Second Phase started in May 2017 and last date for collection of the data was August 2017, and we measured human lactoferrin in the serum. Time between two phases about one month.
Sponsors
National Cancer Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Patients with cachexia related to underlying stage IV non-small cell lung cancer, Apparent healthy controls should not being diagnosed with any type of cancer or have been treated from cancer.
Exclusion criteria
Metastasis in the brain or in bone, patients with severe illness, unstable angina, congestive heart failure, heart attack during the last month, cognitive impairment, unable to give a consent.
Outcome results
None listed