Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000913370
Ethics application status
Approved
Date submitted
15/06/2017
Date registered
22/06/2017
Date last updated
11/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bovine Lactoferrin for treatment of anaemia associated with advanced cancer
Scientific title
Bovine Lactoferrin for the treatment of anaemia associated with cancer cachexia related to underlying stage IV non-small cell lung cancer'
Secondary ID [1] 292206 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 303692 0
Cancer Cachexia 303703 0
Condition category
Condition code
Blood 303066 303066 0 0
Anaemia
Cancer 303107 303107 0 0
Lung - Non small cell
Musculoskeletal 303108 303108 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298360 0
Treatment: Other
Comparator / control treatment
RCT, single blinded, two group of controls, apparent healthy, the other group patients with cacherxia related to underlying stage IV non-small cell lung cancer

We have two controls, one will receive placebo and the apparent healthy will receive 250 mg of bovine lactoferrin
Cachexia control group will receive placebo (microcellulose tablets).
Apparent healthy group will receive 250 mg bovine Lactoferrin
Control group
Placebo

Outcomes
Primary outcome [1] 302444 0
We will measure haemoglobin concentration by using blood samples on two occasions, 1st before starting the study as baseline and 2nd sample will be taken after 12 weeks (end of the study).
Timepoint [1] 302444 0
12 weeks
Secondary outcome [1] 336092 0
Change in serum level of iron
Timepoint [1] 336092 0
after 12 weeks
Secondary outcome [2] 336152 0
Change in red blood cells (RBCs) count
Timepoint [2] 336152 0
12 weeks
Secondary outcome [3] 345354 0
measure human lactoferrin from serum using Lactoferrin Human Simple Step ELISA Kit
Timepoint [3] 345354 0
12 weeks from start of the second phase, which is the end of second phase.

Eligibility
Key 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.
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by the computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
It was two phases, first phase started in December 2016 and completed in March 2017, in this phase we measured HB, serum iron level and RBCs count.
Second Phase started in May 2017 and last date for collection of data was in August 2017, and we measured human lactoferrin in the second phase.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS 23

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
5/12/2016
Date of last participant enrolment
Anticipated
29/12/2017
Actual
8/05/2017
Date of last data collection
Anticipated
22/03/2018
Actual
8/08/2017
Sample size
Target
130
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 8986 0
Egypt
State/province [1] 8986 0
Cairo

Funding & Sponsors
Funding source category [1] 296745 0
University
Name [1] 296745 0
National Cancer Institute
Country [1] 296745 0
Egypt
Primary sponsor type
University
Name
National Cancer Institute
Address
Fom El Khalid Cairo 11796 Egypt
Country
Egypt
Secondary sponsor category [1] 295719 0
None
Name [1] 295719 0
None
Address [1] 295719 0
None
Country [1] 295719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297972 0
National Cancer Institute, Cairo University, Egypt
Ethics committee address [1] 297972 0
Ethics committee country [1] 297972 0
Date submitted for ethics approval [1] 297972 0
Approval date [1] 297972 0
04/10/2016
Ethics approval number [1] 297972 0
201617001.2P

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75626 0
Prof Wafaa Taha
Address 75626 0
Fom El Khalid Cairo 11796 Egypt
Country 75626 0
Egypt
Phone 75626 0
+201222168097
Fax 75626 0
Email 75626 0
wafataha1212@hotmail.com
Contact person for public queries
Name 75627 0
Wafa Taha
Address 75627 0
Fom El Khalid Cairo 11796 Egypt National Cancer Institute, Cairo
Country 75627 0
Egypt
Phone 75627 0
+201222168097
Fax 75627 0
+61352271148
Email 75627 0
wafataha1212@hotmail.com
Contact person for scientific queries
Name 75628 0
Wafa Taha
Address 75628 0
Fom El Khalid Cairo 11796 National Cancer Institute, Cairo
Country 75628 0
Egypt
Phone 75628 0
+201222168097
Fax 75628 0
Email 75628 0
wafataha1212@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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