Yunzhi as Dietary Supplement in Breast Cancer (YUNZHI-BC)

Hospital Clinic of Barcelona

Status and phase: Unknown; Phase 4

Conditions: Breast Cancer

Treatments: Dietary Supplement: Yunzhi extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00647075

YUNZHI-BC

Details and patient eligibility

About

The purpose of this study is to assess the effects of a dietary supplement, the traditional Asian mushroom Yunzhi, as adjuvant in the treatment of patients with breast cancer.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women with diagnosis of breast cancer
2. Undergoing adjuvant/neoadjuvant chemotherapy with either FEC, FAC, TAC, or EC + docetaxel combinations.
3. ≥ 18 years of age
4. Performance status: 0-2
5. Ability to provide written informed consent

Exclusion criteria

1. Any prior history of yunzhi use
2. Use of other herbal remedies during the study duration
3. Significant cardiac, pulmonary, renal, hepatic, gastrointestinal, CNS, psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the participant a poor candidate for study participation
4. Pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization)
5. Systemic use of progestins, androgens or other steroids (dexamethasone is allowed if used as antiemetic therapy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Yunzhi extract 3.5 g/day

Treatment:

Dietary Supplement: Yunzhi extract

2

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo