Study of the interaction between Complementary and Alternative Medicine and standard anti-cancer therapy in women with breast cancer

Phase 4

Completed

• Conditions: Breast cancer; Cancer - Breast; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12615000673549
• Lead Sponsor: Gregory Peterson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified