Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028964
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2002-01-04
Brief Title:
Combination Chemotherapy After Surgery With or Without Chinese Herbal Therapy to Treat Symptoms in Women With Breast Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Randomized Double Blind Pacebo-Controlled Study to Assess The Feasibility Toxicity And Efficacy Phase III Of A Chinese Herbal Therapy CHT For Symptom Management In Women Undergoing Chemotherapy For Stage IIIIII Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Herbs used in traditional Chinese medicine may decrease the side effects of chemotherapy
PURPOSE Randomized phase III trial to study the effectiveness of herbs used in traditional Chinese medicine in decreasing the side effects of chemotherapy after surgery in women who have stage I stage II or early stage III breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of herbs used in traditional Chinese medicine in decreasing the side effects of chemotherapy after surgery in women who have stage I stage II or early stage III breast cancer
Detailed Description:
OBJECTIVES
Determine the toxic effects and safety of chinese herbal therapy CHT when administered for toxicity attenuation in combination with adjuvant doxorubicin and cyclophosphamide in women with stage I II or early stage III breast cancer
Determine patient compliance and the feasibility of using CHT by daily treatment calendars weekly symptom inventories and quality of life and mood state questionnaires completed by these patients
Determine patient preferences and concerns about CHT
Determine preliminarily the efficacy of CHT in ameliorating the toxic effectsside effects of adjuvant chemotherapy with doxorubicin and cyclophosphamide in terms of the incidence and severity of adverse events in these patients
OUTLINE This is a randomized placebo-controlled double-blind study Patients are randomized to one of two treatment arms
Arm I Patients receive adjuvant doxorubicin IV and cyclophosphamide IV over 1 hour on days 0 21 42 and 63 Patients also receive oral chinese herbal therapy three times daily on days -10 to 105
Arm II Patients receive adjuvant chemotherapy as in arm I and oral placebo three times daily on days -10 to 105
Quality of life is assessed at baseline and on days 3 24 45 66 84 and 105
Patients are followed at day 105
PROJECTED ACCRUAL A total of 60 patients 30 per treatment arm will be accrued for this study
Determine the toxic effects and safety of chinese herbal therapy CHT when administered for toxicity attenuation in combination with adjuvant doxorubicin and cyclophosphamide in women with stage I II or early stage III breast cancer
Determine patient compliance and the feasibility of using CHT by daily treatment calendars weekly symptom inventories and quality of life and mood state questionnaires completed by these patients
Determine patient preferences and concerns about CHT
Determine preliminarily the efficacy of CHT in ameliorating the toxic effectsside effects of adjuvant chemotherapy with doxorubicin and cyclophosphamide in terms of the incidence and severity of adverse events in these patients
OUTLINE This is a randomized placebo-controlled double-blind study Patients are randomized to one of two treatment arms
Arm I Patients receive adjuvant doxorubicin IV and cyclophosphamide IV over 1 hour on days 0 21 42 and 63 Patients also receive oral chinese herbal therapy three times daily on days -10 to 105
Arm II Patients receive adjuvant chemotherapy as in arm I and oral placebo three times daily on days -10 to 105
Quality of life is assessed at baseline and on days 3 24 45 66 84 and 105
Patients are followed at day 105
PROJECTED ACCRUAL A total of 60 patients 30 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2042 | None | None | None |
| UCSF-CRO-97755 | None | None | None |
| UCSF-IND-54870 | None | None | None |