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NCT00046891 · ClinicalTrials.gov registry record · Phase 3
EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
A Phase 3 study of Breast Cancer and Neurotoxicity, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
- 20
- Study locations
NCT00046891: Completed Phase 3 study of Breast Cancer and Neurotoxicity, sponsored by Alliance for Clinical Trials in Oncology.
NCT00046891 is a Phase 3 study of Breast Cancer and Neurotoxicity that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 226 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00046891, a Phase 3 study of Breast Cancer and Neurotoxicity, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Chemotherapy may cause memory loss, attention loss, and other problems that make it difficult for patients to think clearly. EGb761 may help maintain mental clarity in patients undergoing chemotherapy. PURPOSE: Randomized clinical trial to study the effectiveness of EGb761 in preventing loss of mental clarity in women who are receiving chemotherapy for newly diagnosed breast cancer.
Primary Outcome
The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Ginkgo Biloba
Study Locations (20)
Colorado
- Aurora Presbyterian Hospital - Aurora
- Boulder Community Hospital - Boulder
- Penrose Cancer Center at Penrose Hospital - Colorado Springs
- Porter Adventist Hospital - Denver
- Presbyterian - St. Luke's Medical Center - Denver
- St. Joseph Hospital - Denver
- Rose Medical Center - Denver
- CCOP - Colorado Cancer Research Program, Incorporated - Denver
- Swedish Medical Center - Englewood
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center - Grand Junction
- Sky Ridge Medical Center - Lone Tree
- Hope Cancer Care Center at Longmont United Hospital - Longmont
- St. Mary-Corwin Regional Medical Center - Pueblo
- North Suburban Medical Center - Thornton
California
- Santa Barbara Hematology Oncology - Lompoc - Lompoc
- Sansum Medical Clinic - Santa Barbara
- Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara - Santa Barbara
- Cancer Center of Santa Barbara - Snata Barbara
- Santa Barbara Hematology Oncology - Solvang - Solvang
Arizona
- Mayo Clinic Scottsdale - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2002-12 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT00046891 record still lists
NCT00046891 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00046891 names 20 study sites across 3 states, led by Colorado, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT00046891 about?
NCT00046891 is a clinical study titled "EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer". RATIONALE: Chemotherapy may cause memory loss, attention loss, and other problems that make it difficult for patients to think clearly. EGb761 may help maintain mental clarity in patients undergoing chemotherapy. PURPOSE: Randomized clinical trial to study the effectiveness of EGb761 in preventing ...
What is the current status of trial NCT00046891?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2002-12. Estimated completion is 2015-04.
What conditions does trial NCT00046891 study?
This clinical trial studies the following conditions: Breast Cancer, Neurotoxicity.
What interventions are being tested in trial NCT00046891?
The interventions under investigation include: Placebo (OTHER), Ginkgo Biloba (DRUG).
Who is sponsoring clinical trial NCT00046891?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00046891 being conducted?
This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00046891's enrollment target sits among peer trials
226 340th of 1224 higher than 885 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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