Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression (DAGMAR)

Danish Cancer Society

Status: Withdrawn

Conditions: Breast Cancer; Breast Cancer Female; Breast Neoplasms

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lignans; Dietary Supplement: Soy isoflavones

Study type: Interventional

Funder types: Other

Identifiers

NCT04880369

R174-A11507-17-S52

Details and patient eligibility

About

The aim is to investigate if soy isoflavones and lignans affect markers of disease progression and gene expression among breast cancer patients receiving neo-adjuvant treatment in a three arm, double-blinded, randomized placebo-controlled trial (RCT) comparing: soy isoflavone supplementation, lignan supplementation, and placebo.

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with breast cancer at "Brystkirurgisk Afdeling" at Rigshospitalet and Herlev Hospitals (within the last 30 days).
• Advised (and accepted) to receive neo-adjuvant treatment
• Primary unilateral breast cancer
• Treatment is expected to be curative
• Is expected to be able to attend surgery

Exclusion criteria

• Allergic to soy
• Celiac disease
• Inflammatory bowel disease
• Not understanding Danish (patient material and questionnaires are in Danish)
• Prior diagnosis of breast cancer
• Use of dietary supplements containing lignans or isoflavones three months prior to diagnosis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Lignan capsule

Experimental group

Description:

1 capsule/day from baseline to end-of-follow-up (approx. 4 months)

Treatment:

Dietary Supplement: Lignans

Isoflavones capsule

Experimental group

Description:

1 capsule/day from baseline to end-of-follow-up (approx. 4 months)

Treatment:

Dietary Supplement: Soy isoflavones

Placebo capsule

Placebo Comparator group

Description:

1 capsule/day from baseline to end-of-follow-up (approx. 4 months)

Treatment:

Dietary Supplement: Placebo