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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000673549
• Date of registration: 29/06/2015
• Prospective Registration: No
• Primary sponsor: Gregory Peterson
• Public title: Study of the interaction between Complementary and Alternative Medicine and standard anti-cancer therapy in women with breast cancer
• Scientific title: A Pilot pharmacokinetic study of the interaction between two systemic Complementary and Alternative Medicines and standard therapy in patients with active breast cancer malignancy
• Date of first enrolment: 08/04/2013
• Target sample size: 20
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000673549.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Pharmacokinetics;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Prof Gregory Peterson

• Name: Prof Gregory Peterson

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Alternative and Complementary Medicine - Other alternative and complementary medicine

Cancer - Breast

Breast cancer;
Breast cancer

Intervention(s)

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.

Primary Outcome(s)

Steady-state plasma levels of letrozole.[Three weeks after concomitant dosing of fucoidan]

Steady-state plasma levels of tamoxifen metabolites (4-hydroxytamoxifen and endoxifen).[Three weeks after concomitant therapy with fucoidan.]

Steady-state plasma levels of tamoxifen.[Three weeks after concomitant therapy with fucoidan.]

Secondary Outcome(s)

Adverse reactions possibly due to fucoidan or cancer therapy.
At baseline, patients underwent a physical examination and demographics were collected. Blood samples were also collected for toxicity and pharmacokinetic analysis. At the end of the dosing interval, patients underwent the same physical examination and blood samples were collected for toxicity and pharmacokinetic analysis. Blood tests were urea, electrolytes and creatinine (UEC), liver function tests (LFTs) and full blood count (FBC).
Adverse drug reactions of letrozole and tamoxifen were graded using the NCI Common Terminology Criteria for Adverse Events Version 4.0 for haematological and non-haematological toxicities. [Three weeks after concomitant therapy with fucoidan]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Royal Hobart Hospital Research Foundation

Secondary Sponsor(s)

Raymond Lowenthal

Ethics review

Status: Approved
Approval date:
Contact:

Human Research Ethics Committee (Tasmania) Network