None listed
Conditions
Brief summary
Background. Although the use of complementary and alternative medicines is widespread in cancer patients, clinical evidence of their benefits is sparse. Furthermore, while they are often assumed to be safe with regards to concurrent use of anti-cancer therapies, few studies have been carried out to investigate possible interactions. Fucoidans are a group of sulfated carbohydrates, derived from marine brown algae, which have long been used as dietary supplements due to their reported medicinal properties, including anti-cancer activity. The aim of this study was to investigate the effect of co-administration of fucoidan, derived from Undaria pinnatifida, on the pharmacokinetics of two commonly used hormonal therapies, letrozole and tamoxifen, in patients with breast cancer. Methods. This was an open label non-crossover study in patients with active malignancy taking letrozole or tamoxifen (n = 10 for each group). Patients took oral fucoidan, given in the form of Maritech ('Registered Trademark') extract, for a three-week period (500mg twice daily). Trough plasma concentrations of letrozole, tamoxifen, 4-hydroxytamoxifen and endoxifen were measured using HPLC-CAD, at baseline and after concomitant administration with fucoidan. Results. No significant changes in steady-state plasma concentrations of letrozole, tamoxifen or tamoxifen metabolites were detected after co-administration with fucoidan. In addition, no adverse effects of fucoidan were reported and toxicity monitoring showed no significant differences in all parameters measured over the study period. Conclusions. Administration of Undaria pinnatifida fucoidan had no significant effect on the steady-state trough concentrations of letrozole or tamoxifen, and was well tolerated. These results suggest that fucoidan in the studied form and dosage could be taken concomitantly with letrozole and tamoxifen without the risk of clinically significant interactions.
Interventions
This study will investigate the possible interaction between a commonly used CAM and standard anti-cancer therapies (namely hormonal agents & chemotherapy) for breast cancer. Patients with active malignancy who have been taking once daily oral doses of either letrozole (2.5mg) or tamoxifen (20mg) for a minimum of four weeks prior to the study, to ensure steady-state had been achieved, with at least three weeks of therapy remaining in their treatment course, are to be included. Patients will take
This study will investigate the possible interaction between a commonly used CAM and standard anti-cancer therapies (namely hormonal agents & chemotherapy) for breast cancer. Patients with active malignancy who have been taking once daily oral doses of either letrozole (2.5mg) or tamoxifen (20mg) for a minimum of four weeks prior to the study, to ensure steady-state had been achieved, with at least three weeks of therapy remaining in their treatment course, are to be included. Patients will take oral fucoidan (derived from seaweed), given in the form of Maritech ('Registered Trademark') extract, for a three-week period (500mg twice daily). Adherence will be monitored by pill count.
Sponsors
Gregory Peterson
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants had active (locally advanced/recurrent or metastatic) breast cancer and had been taking a stable once daily oral dose of either letrozole (2.5mg) or tamoxifen (20mg) for a minimum of four weeks prior to the study, to ensure steady-state had been achieved, with at least three weeks of therapy remaining in their treatment course. Other inclusion criteria were as follows: aged greater than or equal to 18 years; able to complete documentation of the treatment and adverse events, and attend follow-up; and able to swallow capsules whole.
Exclusion criteria
Patients were excluded if they met any of the following criteria: reluctance or inability to cease other CAM at least a week prior to trial commencement; ECOG performance of greater than or equal to 3; life expectancy of less than or equal to 12 weeks; impaired haematopoietic (WBC < 3.0 x 109/L, ANC < 1.5 x 109/L, platelet < 100 x 109/dL), renal (GFR < 50mL/min) or hepatic function (either AST/ALT > 2.5 ULN, or > 5 x ULN in case of liver metastases, or bilirubin > 1.5 x ULN); pregnancy or lactation; cerebral or leptomeningeal metastases that were unstable in spite of appropriate therapy; serious intercurrent illness; major surgery within two weeks prior to study commencement; concurrent radiotherapy; bowel obstruction; documented allergy to fucoidan; concurrent warfarin therapy; and participation in trials of other pharmacological agents during the time of this study.
Outcome results
None listed