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A Randomized, Parallel, Double-blind, Placebo-controlled, Pilot Clinical Study on the Effects of Yunzhi as Dietary Supplement in 60 Adult Patients Undergoing Adjuvant/Neoadjuvant Chemotherapy for Breast Cancer.


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Randomized, Parallel, Double-blind, Placebo-controlled, Pilot Clinical Study on the Effects of Yunzhi as Dietary Supplement in 60 Adult Patients Undergoing Adjuvant/Neoadjuvant Chemotherapy for Breast Cancer.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Pere Gascon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Clinic

Authority:

Spain: Ethics Committee

Study ID:

YUNZHI-BC

NCT ID:

NCT00647075

Start Date:

November 2007

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • undergoing
  • adjuvant/neoadjuvant chemotherapy
  • symptomatic therapy
  • Breast Neoplasms

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