Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395441
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-29
Brief Title:
Wisconsin Ginseng for Decreasing Cancer Related Fatigue
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase III Study of Ginseng for Cancer Related Fatigue
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares the effect of Wisconsin ginseng panax quinquefolius to placebo in patients with cancer that suffer from significant fatigue Fatigue is among the most challenging symptoms to manage in patients with cancer both on or off active treatment This symptom complex meaningfully contributes to psychosocial distress healthcare costs and it also interferes with the delivery of anticancer therapies American ginseng Western ginseng appears to be a promising appearing agent for treating cancer related fatigue Western ginseng may reduce cancer-related fatigue
Detailed Description:
PRIMARY OBJECTIVE
I To determine the efficacy of ginseng as assessed by a single item measure of fatigue at 8 weeks
SECONDARY OBJECTIVES
I To estimate changes in fatigue via the single item measure of fatigue from baseline to week 4 the Global Impression of Change at week 4 and 8 and the Functional Assessment of Chronic Illness Therapy-Fatigue Scale FACIT-Fatigue at week 4 and 8
II To evaluate the frequency and severity of toxicity as reported by the patient on the Ginseng Symptom Experience Diary where patients rate on a 0 to 10 scale their toxicities experienced while on study
OUTLINE Patients are randomized to 1 of 2 groups
GROUP I Patients receive Western ginseng orally PO twice daily BID on days 1-56
GROUP II Patients receive placebo PO BID on days 1-56
I To determine the efficacy of ginseng as assessed by a single item measure of fatigue at 8 weeks
SECONDARY OBJECTIVES
I To estimate changes in fatigue via the single item measure of fatigue from baseline to week 4 the Global Impression of Change at week 4 and 8 and the Functional Assessment of Chronic Illness Therapy-Fatigue Scale FACIT-Fatigue at week 4 and 8
II To evaluate the frequency and severity of toxicity as reported by the patient on the Ginseng Symptom Experience Diary where patients rate on a 0 to 10 scale their toxicities experienced while on study
OUTLINE Patients are randomized to 1 of 2 groups
GROUP I Patients receive Western ginseng orally PO twice daily BID on days 1-56
GROUP II Patients receive placebo PO BID on days 1-56
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03375 | REGISTRY | None | None |
| 23-012122 | OTHER | None | None |
| MC231004 | OTHER | Mayo Clinic in Rochester | None |