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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000860268

Enrollment

135

Registered

2009-10-02

Start date

2009-08-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Healthy volunteers

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.

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

Outcome results