Yunzhi as Dietary Supplement in Breast Cancer (YUNZHI-BC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Clinic of Barcelona
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00647075
First received: March 26, 2008
Last updated: December 14, 2010
Last verified: March 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Dietary Supplement: Yunzhi extract Dietary Supplement: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Treatment adherence Clinical and laboratory (including RBC, WBC and platelets) adverse events Adherence to chemotherapy schedule EPO and blood transfusion needs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Yunzhi extract 3.5 g/day
|
Dietary Supplement: Yunzhi extract
3.5 g/day
|
|
Placebo Comparator: 2
Placebo
|
Dietary Supplement: Placebo
Placebo (starch)
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women with diagnosis of breast cancer
- Undergoing adjuvant/neoadjuvant chemotherapy with either FEC, FAC, TAC, or EC + docetaxel combinations.
- ≥ 18 years of age
- Performance status: 0-2
- Ability to provide written informed consent
Exclusion Criteria:
- Any prior history of yunzhi use
- Use of other herbal remedies during the study duration
- 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
- Pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization)
- Systemic use of progestins, androgens or other steroids (dexamethasone is allowed if used as antiemetic therapy)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647075
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647075
Contacts
| Contact: Pere Gascon, MD | +342275400 | pgascon@clinic.ub.es |
Locations
| Spain | |
| Hospital Parc Tauli | Recruiting |
| Sabadell, Barcelona, Spain, 08208 | |
| Principal Investigator: Miquel A Segui, MD | |
| Hospital Clinic | Recruiting |
| Barcelona, Spain, 08036 | |
| Sub-Investigator: Montse Muñoz, MD | |
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
| Principal Investigator: | Pere Gascon, MD | Hospital Clinic |
More Information
| Responsible Party: | Vita Green Health Products Co. Ltd., Vita Green Europe, S.A. |
| ClinicalTrials.gov Identifier: | NCT00647075 History of Changes |
| Other Study ID Numbers: | YUNZHI-BC |
| Study First Received: | March 26, 2008 |
| Last Updated: | December 14, 2010 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospital Clinic of Barcelona:
|
Breast cancer undergoing adjuvant/neoadjuvant chemotherapy symptomatic therapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on September 30, 2016