Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182780
Status:
COMPLETED
Last Update Posted:
2017-10-31
First Post:
2005-09-15
Brief Title:
American Ginseng in Treating Patients With Cancer-Related Fatigue
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
The Use of American Ginseng Panax Quinquefolius to Improve Cancer-Related Fatigue A Randomized Double-Blind Dose-Finding Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2017-10
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 American ginseng may help relieve cancer-related fatigue
PURPOSE This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue
PURPOSE This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of American ginseng administered at 3 different doses vs placebo in patients with cancer-related fatigue
Secondary
Determine the toxic effects and tolerability of American ginseng in these patients
Determine the impact of American ginseng on quality of life-related variables eg sleep vitality and quality of life domains in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease stage I or II vs III or IV vs unknown gender male vs female baseline fatigue score 4-7 vs 8-10 concurrent chemotherapy yes vs no and concurrent radiotherapy yes vs no Patients are randomized to 1 of 4 treatment arms
Primary
Compare the efficacy of American ginseng administered at 3 different doses vs placebo in patients with cancer-related fatigue
Secondary
Determine the toxic effects and tolerability of American ginseng in these patients
Determine the impact of American ginseng on quality of life-related variables eg sleep vitality and quality of life domains in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease stage I or II vs III or IV vs unknown gender male vs female baseline fatigue score 4-7 vs 8-10 concurrent chemotherapy yes vs no and concurrent radiotherapy yes vs no Patients are randomized to 1 of 4 treatment arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02670 | REGISTRY | None | None |
| CDR0000440907 | REGISTRY | PDQ Physician Data Query | None |