Simultaneous integrated boost for adjuvant treatment of breast cancer--intensity modulated vs. conventional radiotherapy: the IMRT-MC2 trial.

BACKGROUND: Radiation therapy is an essential modality in the treatment of breast cancer. Addition of radiotherapy to surgery has significantly increased local control and survival rates of the disease. However, radiotherapy is also associated with side effects, such as tissue fibrosis or enhanced vascular morbidity. Modern radiotherapy strategies, such as intensity modulated radiotherapy (IMRT), can shorten the overall treatment time by integration of the additional tumor bed boost significantly. To what extent this might be possible without impairing treatment outcome and cosmetic results remains to be clarified. METHODS/DESIGN: The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery. 502 patients will be recruited and randomized into two arms: patients in arm A will receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor bed by integrated boost, while patients in arm B will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 Gy and consecutive boost in 8 fractions to a total dose of 66.4 Gy. DISCUSSION: Primary objectives of the study are the evaluation of the cosmetic results 6 weeks and 2 years post treatment and the 2- and 5-year local recurrence rates for the two different radiotherapy strategies. Secondary objectives are long term overall survival, disease free survival and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov Protocol ID: NCT01322854.

Daily honey consumption does not change CYP3A activity in humans.

Several studies investigating the interaction of honey and drug-metabolizing enzymes showed controversial results, with some suggesting that honey induces CYP3A-mediated metabolism in mammals and humans. This clinical trial was conducted to determine the effect of repeated honey administration on human CYP3A enzyme activity using midazolam as a marker substance. In a randomized, single-blind, parallel-group study, 20 healthy volunteers were randomly assigned to receive either honey (2 × 20 g/d) or artificial honey (2 × 20 g/d) over a period of 10 days. To determine intestinal and hepatic CYP3A activity, oral (4 mg) and intravenous (2 mg) midazolam was administered in a semi-simultaneous way before honey administration, after the last honey administration, and 1 and 6 days thereafter. At baseline after oral midazolam, the partial metabolic clearance was similar in both groups (honey: 917.8 ± 234.6 mL/min vs artificial honey: 973.5 ± 373.8 mL/min). Ten days of honey administration did not change partial metabolic clearance (honey: 1016 ± 268 mL/min vs artificial honey: 1043 ± 450 mL/min), which was also true 1 and 6 days later. Neither honey nor artificial honey in amounts usually consumed affected the intestinal and hepatic CYP3A activity in healthy volunteers.