Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000860268
Ethics application status
Approved
Date submitted
3/08/2009
Date registered
2/10/2009
Date last updated
2/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
'Madu tualang' honey as prophylaxis against febrile neutropenia in patients with haematological malignancy
Scientific title
In neutropenic patients with haematological malignancy, does the use of madu tualang honey lead to less febrile neutropenia compared to oral ciprofloxacin: Open, Randomised, Controlled, Two-Period Cross-Over study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Febrile Neutropenia 243434 0
Haematological malignancies 243454 0
Condition category
Condition code
Alternative and Complementary Medicine 239738 239738 0 0
Other alternative and complementary medicine
Infection 239751 239751 0 0
Studies of infection and infectious agents
Cancer 239752 239752 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Madu tualang honey, 20 gm twice a day consumed orally till recovery of neutropenia, i.e absolute neutrophil count above 1.0 x 10^6/liter
Intervention code [1] 237058 0
Prevention
Comparator / control treatment
Oral Ciprofloxacin (Ciprodac) 500mg twice a day till recovery of neutropenia, i.e absolute neutrophil count above 1.0 x 10^6/liter
Control group
Active

Outcomes
Primary outcome [1] 240490 0
Rate of febrile neutropenia (FN).
4 hourly oral temperature monitoring using digital oral thermometer (Terumo) .
Full blood count (including absolute neutrophil count) is measured from Day 7 of chemotherapy till recovery from neutropenia (> 1.0 x 10^6/Liter). Onset of fever [defined as either (38 degree celcius twice an hour apart when there is no evidence of sepsis) OR (38C once when there is evidence of sepsis)
] during neutropenia indicate febrile neutropenia. (primary outcome).
Timepoint [1] 240490 0
Temperature measurement is started immediately upon commencing chemotherapy until recovery from neutropenia.
If the blood count is normal at starting chemotherapy, full blood count (FBC) including absolute neutrophil count is measured every other day from Day 7 of chemotherapy till recovery from neutropenia (> 1.0 x 10^6/Liter). FBC measurement is started earlier if subject have evidence of marrow infiltration.
Primary outcome [2] 240517 0
Duration of neutropenia
Full blood count (including absolute neutrophil count) is measured from Day 7 of chemotherapy till recovery from neutropenia (> 1.0 x 10^6/Liter).
Timepoint [2] 240517 0
If the blood count is normal at starting chemotherapy, full blood count (FBC) including absolute neutrophil count is measured every other day from Day 7 of chemotherapy till recovery from neutropenia (> 1.0 x 10^6/Liter). FBC measurement is started earlier if subject have evidence of marrow infiltration.
Secondary outcome [1] 257040 0
Difference in the depth of neutropenia
Timepoint [1] 257040 0
If the blood count is normal at starting chemotherapy, full blood count (including absolute neutrophil count) is measured every other day from Day 7 of chemotherapy till recovery from neutropenia (> 1.0 x 10^6/Liter). FBC measurement is started earlier if subject have evidence of marrow infiltration.

Eligibility
Key inclusion criteria
Confirmed to suffer from blood cancer and Plan to receive at least 2 cycles of same chemotherapy regime.
Functional status of European Cooperative Oncology Group (ECOG) score of 3 and better.
Consented and signed the consent form.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of allergy to ciprofloxacin.
history of allergy to honey product.
undergoing high dose chemotherapy for stem cell transplantation.
serius diabetes requiring intravenous insulin infusion.
pregnant or breast-feeding.
already ommenced on antibiotics for other than prophylactic indications prior to chemotherapy making the use of ciprofloxacin unnecessary.
Impaired renal function (serum creatinine > 300 micromol/L).
Impaired liver excretory function (serum bilirubin > 85 micromol/L).
Impaired liver cell integrity (alanin transaminase [ALT] > 5x upper limit of normal

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment outside Australia
Country [1] 1931 0
Malaysia
State/province [1] 1931 0
Kota Bharu

Funding & Sponsors
Funding source category [1] 237433 0
University
Name [1] 237433 0
Universiti Sains Malaysia (USM)
Country [1] 237433 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia
Address
School of Medical Sciences
Health Campus
USM
16150 Kota Bharu
Kelantan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 236924 0
None
Name [1] 236924 0
Address [1] 236924 0
Country [1] 236924 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239561 0
USM Human Reserch Ethical Committee
Ethics committee address [1] 239561 0
Ethics committee country [1] 239561 0
Malaysia
Date submitted for ethics approval [1] 239561 0
Approval date [1] 239561 0
Ethics approval number [1] 239561 0

Summary
Brief summary
Patient receiving myeloablative chemotherapy are at risk of developing febrile neutropenia (FN) which is an oncology emergency. Most FN are microbilogically negative but infection are mainly opportunistic infection arising from the gastrointestinal tract. Chemotherapy leads to mucosal injury besides the marked drop in peripheral white cell count. Ciprofloxacin has been used as a selective gut decontamination to reduce the amount of gut flora. Honey has been shown to have both antimicrobial activiti as well as mucosal protectation. Uncontrolled study also showed that honey shortened period of neutropenia. We do not know if this is due to true accelerated marrow rejuvenation or that the level of chemotheray was depressed following drug-honey interaction. 'Madu tualang' is a local honey product which is being studied if the above research question can be answered in controlled clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30000 0
Address 30000 0
Country 30000 0
Phone 30000 0
Fax 30000 0
Email 30000 0
Contact person for public queries
Name 13247 0
Abu Dzarr Abdullah
Address 13247 0
Department of Medicine
School of Medical Sciences
Health Campus
USM, 16150 Kota Bharu, Kelantan
Country 13247 0
Malaysia
Phone 13247 0
+60 9 7673878
Fax 13247 0
Email 13247 0
abudzarr@hematologi.net
Contact person for scientific queries
Name 4175 0
Abu Dzarr Abdullah
Address 4175 0
Department of Medicine
School of Medical Sciences
Health Campus
USM, 16150 Kota Bharu, Kelantan
Country 4175 0
Malaysia
Phone 4175 0
+60 9 7673878
Fax 4175 0
Email 4175 0
abudzarr@hematologi.net

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
No documents have been uploaded by study researchers.

Documents added automatically
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