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Fatigue

Neoplasms, Second Primary

Herbal and Botanical

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Ginseng

Participants will be instructed to take two (2) capsules, three (3) times a day in the morning, at noon and in the evening (before going to bed), for a total of 6 capsules a day, with food for 12 weeks. If a dose is missed participants are instructed to take the missed dose as soon as possible.

Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).

Redsenol-1 Plus

Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).

Placebo

Erin Lewis, PhD

David Crowley, MD

The primary objective of this study is to evaluate the safety and efficacy of Redsenol-1 Plus on cancer-related fatigue (CRF) in adults. The change in the severity of CRF from baseline at week 12 will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale, and compared between Redsenol-1 Plus and placebo groups. Additionally, the safety and tolerability of Redsenol-1 Plus, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).

The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults

A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults

The change in the severity of cancer-related fatigue from baseline to week 12 as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale will be compared between Redsenol-1 Plus and placebo.

The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8 as assessed by the FACIT-F fatigue subscale will be compared between Redsenol-1 Plus and placebo.

The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F total score.

The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F physical well-being (PWB) sub-scale.

The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the social well-being (SWB) sub-scale.

The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the emotional well-being (EWB) sub-scale.

The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the functional well-being (FWB) sub-scale.

The difference in the proportion of participants who have a clinically important change in severity of cancer-related fatigue as assessed by the FACIT-F fatigue subscales from baseline to 4 weeks, 8 weeks, and 12 weeks between Redsenol-1 Plus compared to placebo.

The difference in performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) tool from baseline to weeks 4, 8, and 12 between Redsenol-1 Plus compared to placebo.

The difference in mood as assessed by the Profile of Mood States (POMS) questionnaire from baseline to weeks 4, 8, and 12 between Redsenol-1 Plus compared to placebo.

Incidence of pre-emergent and post-emergent adverse events following supplementation with Redsenol-1 Plus or placebo for 12 weeks will be collected at screening and baseline and will be compared to post-emergent AEs to enable identification of AEs that may be potentially related to the investigational product.

Blood pressure at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks. Blood pressure will be determined from 3 measurements obtained at least 1 minute apart. One arm will be chosen and used consistently throughout the study. Blood pressure will be checked in both arms at the first examination.

Heart rate at baseline and following supplementation with Redsenol-1 Plus or placebo will be will be determined from 3 measurements obtained at least 1 minute apart. One arm will be chosen and used consistently throughout the study. Blood pressure will be checked in both arms at the first examination.

Aspartate aminotransferase (AST) will be measured in blood from study participants at 12 weeks.

Alanine aminotransferase (ALT) will be measured in blood from study participants at 12 weeks.

Alkaline phosphatase (ALP) will be measured in blood from study participants at 12 weeks.

Total bilirubin will be measured in blood from study participants at 12 weeks.

Creatinine will be measured in blood from study participants at 12 weeks.

Electrolytes will be measured in blood from study participants at 12 weeks.

Glucose will be measured in blood from study participants at 12 weeks.

Estimated glomerular filtration rate (eGFR) will be measured in blood from study participants at 12 weeks.

White blood cell count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils) will be measured in blood from study participants at 12 weeks.

Red blood cell count will be measured in blood from study participants at 12 weeks.

Hemoglobin will be measured in blood from study participants at 12 weeks.

Hematocrit will be measured in blood from study participants at 12 weeks.

Platelet count will be measured in blood from study participants at 12 weeks.

Mean corpuscular volume will be measured in blood from study participants at 12 weeks.

Mean corpuscular hemoglobin will be measured in blood from study participants at 12 weeks.

Mean corpuscular hemoglobin concentration will be measured in blood from study participants at 12 weeks.

Red blood cell distribution will be measured in blood from study participants at 12 weeks.

Immature granulocytes will be measured in blood from study participants at 12 weeks.

Nucleated red blood cells will be measured in blood from study participants at 12 weeks.

Incidence of adverse events during the 4-week follow-up period (weeks 12-16).

KGK Science Inc.

Canada Royal Enoch Phytomedicine Co., Ltd.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle. Subjects will receive 1,000 mg ginseng orally twice daily every day for 4 weeks (2 cycles).

Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle for 2 cycles.

All subjects will receive regorafenib 160 mg orally once daily for the first 21 days of each 28-day cycle for 2 cycles.

Regorafenib

Subjects randomized to ginseng will receive 1,000 mg orally twice every day of each 28-day cycle for 2 cycles.

Rodwige J. Desnoyers, M.D.

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.

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 MFSI-SF instrument and PROMIS. Subjects will have a pill count 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.

Efficacy of Ginseng for Patients on Regorafenib

A Randomized Phase II Trial to Evaluate the Efficacy of Supportive Therapy With Ginseng for Patients on Treatment With Regorafenib

Fatigue will be assessed for subjects on each arm using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) and Patient-Reported Outcomes Measurement Information System (PROMIS)

Pill counts will be used to assess adherence to regorafenib for subjects on each arm

Toxicity assessed using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0) criteria

Retention will be determined by the proportion of subjects on each arm who complete the study.

the proportion of all subject with confirmed PR or CR according to RECIST v.1.1, from the start of treatment until disease progression/recurrence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults	NCT05664009	Fatigue Cancer, Treatme...	Redsenol-1 Plus Placebo	18 Years -	Canada Royal Enoch Phytomedicine Co., Ltd.
Efficacy of Ginseng for Patients on Regorafenib	NCT02581059	Colorectal Canc... Palliative Medi... Supportive Care	Regorafenib Ginseng	18 Years -	Hoosier Cancer Research Network
Efficacy of Ginseng for Patients on Regorafenib	NCT02581059	Colorectal Canc... Palliative Medi... Supportive Care	Regorafenib Ginseng	18 Years -	Hoosier Cancer Research Network

Spots Global Cancer Trial Database for ginseng

Every month we try and update this database with for ginseng cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ginseng

Every month we try and update this database with for ginseng cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ginseng cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.