Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-31 @ 5:55 PM
Study NCT ID:
NCT02581059
Status:
TERMINATED
Last Update Posted:
2024-06-26
First Post:
2015-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Ginseng for Patients on Regorafenib
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Randomized Phase II Trial to Evaluate the Efficacy of Supportive Therapy With Ginseng for Patients on Treatment With Regorafenib
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funder terminated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.
Detailed Description:
OUTLINE: This is a multi-center study.
INVESTIGATIONAL TREATMENT:
Regorafenib will be administered 160 mg orally once daily for the first 21 days of each 28-day cycle. Subjects that randomize to receive ginseng will take 1,000 mg orally twice daily every day for 4 weeks (2 cycles). Subjects that randomize to NOT receive ginseng will not be given ginseng. Subjects will be instructed to take regorafenib with a low-fat meal.
Subjects will undergo fatigue assessments, using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument and Patient-Reported Outcomes Measurement Information System (PROMIS). Subjects will have a pill count cycle 2 day 1 (C2D1) and at the end of treatment visit. Subjects will have the re-staging scan (CT of chest/abdomen/pelvis) at the end of Cycle 2/ week 8 (±5).
Adequate bone marrow, liver and renal function assessed by the following laboratory values obtained within 7 days prior to registration for protocol therapy:
Hematopoietic:
* Absolute neutrophil count (ANC) count \> 1,500/mm\^3
* Hemoglobin (Hgb) \> 9g/dL
* Platelet count \> 100,000/mm\^3
Renal:
* Serum creatinine ≤ 1.5 × the upper limit of normal (ULN)
Hepatic:
* Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
* Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
* Alkaline phosphatase (ALP) limit ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
Coagulation:
* International normalized ratio (INR)/Partial thromboplastin time (PTT) ≤ 1.5 × ULN. NOTE: Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable, based on a measurement that is pre-dose as defined by the local standard of care. Warfarin does should not exceed 1 mg.
INVESTIGATIONAL TREATMENT:
Regorafenib will be administered 160 mg orally once daily for the first 21 days of each 28-day cycle. Subjects that randomize to receive ginseng will take 1,000 mg orally twice daily every day for 4 weeks (2 cycles). Subjects that randomize to NOT receive ginseng will not be given ginseng. Subjects will be instructed to take regorafenib with a low-fat meal.
Subjects will undergo fatigue assessments, using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument and Patient-Reported Outcomes Measurement Information System (PROMIS). Subjects will have a pill count cycle 2 day 1 (C2D1) and at the end of treatment visit. Subjects will have the re-staging scan (CT of chest/abdomen/pelvis) at the end of Cycle 2/ week 8 (±5).
Adequate bone marrow, liver and renal function assessed by the following laboratory values obtained within 7 days prior to registration for protocol therapy:
Hematopoietic:
* Absolute neutrophil count (ANC) count \> 1,500/mm\^3
* Hemoglobin (Hgb) \> 9g/dL
* Platelet count \> 100,000/mm\^3
Renal:
* Serum creatinine ≤ 1.5 × the upper limit of normal (ULN)
Hepatic:
* Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
* Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
* Alkaline phosphatase (ALP) limit ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
Coagulation:
* International normalized ratio (INR)/Partial thromboplastin time (PTT) ≤ 1.5 × ULN. NOTE: Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable, based on a measurement that is pre-dose as defined by the local standard of care. Warfarin does should not exceed 1 mg.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HCRN GI14-191 | OTHER | Hoosier Cancer Research Network | View |