RecruitingACTRN12609000860268

Madu tualang' honey as prophylaxis against febrile neutropenia in patients with haematological malignancy

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


Sponsor

Universiti Sains Malaysia

Enrollment

135 participants

Start Date

Aug 5, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a traditional honey product called 'Madu Tualang' can help prevent dangerous infections in people with blood cancer who are receiving chemotherapy. Chemotherapy can severely reduce white blood cell counts, leaving patients very vulnerable to infection. Researchers want to find out if taking honey alongside a standard antibiotic (ciprofloxacin) can further protect patients by reducing bacteria in the gut and protecting the gut lining. You may be eligible if: - You have a confirmed diagnosis of blood cancer (haematological malignancy) - You are planning to receive at least 2 cycles of the same chemotherapy regimen - Your functional status (ECOG score) is 3 or better - You are 12 years or older - You have signed the consent form You may NOT be eligible if: - You have a known allergy to ciprofloxacin - You have a known allergy to honey products - You are having high-dose chemotherapy for a stem cell transplant - You have severe diabetes requiring intravenous insulin - You are pregnant or breastfeeding - You already have an active infection requiring antibiotics - You have severe kidney or liver disease Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

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


Locations(1)

Kota Bharu, Malaysia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12609000860268


Related Trials