Redsenol-1 Plus for Cancer-related Fatigue

Overseen By Erin Lewis, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Canada Royal Enoch Phytomedicine Co., Ltd.

Must not be taking: Antidepressants, Antihypertensives, others

Disqualifiers: Pregnancy, CNS malignancies, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Redsenol-1 Plus (Noble Ginsenoside Capsules) to determine if it can reduce fatigue in individuals who have had cancer and continue to experience tiredness. Participants will be divided into two groups: one receiving the actual treatment and the other receiving a placebo (a pill with no active ingredients) to compare results over 12 weeks. The trial seeks adults who have experienced this type of fatigue for at least a month and have completed their cancer treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does require you to maintain your current lifestyle habits, including medications, as much as possible. However, you should avoid taking new supplements during the study period.

Is there any evidence suggesting that Redsenol-1 Plus is likely to be safe for humans?

Research shows that Redsenol-1 Plus is under study for its effects on cancer-related tiredness. Early studies have not identified any major harmful effects. Redsenol-1 Plus is a concentrated form of ginseng, containing active ingredients called ginsenosides. In other treatments, ginsenosides have generally been safe for patients.

As this treatment is in a phase 2 trial, early evidence suggests it is safe enough for testing in more people. Ongoing trials will provide more information about its safety. Researchers closely monitor participants to quickly identify any unexpected problems. Always consult a healthcare professional before joining a trial to understand the risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer-related fatigue?

Researchers are excited about Redsenol-1 Plus for cancer-related fatigue because it offers a unique approach compared to standard treatments like exercise, cognitive behavioral therapy, and medications such as psychostimulants. Unlike these options, Redsenol-1 Plus is derived from ginsenosides, which are compounds found in ginseng that may have energizing properties. This treatment aims to directly combat fatigue by potentially boosting energy levels naturally, without the side effects often associated with stimulants. Additionally, its oral capsule form allows for easy administration, making it a convenient option for patients.

What evidence suggests that Redsenol-1 Plus might be an effective treatment for cancer-related fatigue?

Research has shown that ginseng, a key ingredient in Redsenol-1 Plus, effectively reduces cancer-related tiredness in several studies. This supplement contains a high amount of rare ginsenosides, active ingredients believed to increase energy and reduce fatigue. In past studies, patients taking ginseng reported noticeable improvements in their tiredness levels. This trial will compare Redsenol-1 Plus to a placebo to evaluate its potential in helping people experiencing fatigue due to cancer. While promising, more research is needed to confirm its effectiveness. ^{1 3 6 7 8}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

Adults aged 18-65 who have completed cancer treatment and are experiencing fatigue, with a CRF score of ≥4. Women must not be pregnant or planning pregnancy, using reliable birth control if applicable. Participants should have stable health without certain conditions like CNS malignancies, untreated high blood pressure, recent major surgery, or substance abuse.

Inclusion Criteria

I have cancer-related fatigue rated 4 or higher.

I am able to bear children, have a negative pregnancy test, and will use birth control during the study.

CRF present for at least one month prior to screening

Exclusion Criteria

I haven't had major surgery in the last 3 months and don't plan any during the study.

I am unable to understand and give consent for treatment.

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Redsenol-1 Plus or placebo for cancer-related fatigue, taking 6 capsules daily for 12 weeks

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on adverse events

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Redsenol-1 Plus

Trial Overview

The trial is testing Redsenol-1 Plus against a placebo to see if it helps reduce cancer-related fatigue in adults post-cancer treatment. The main measure is the change in fatigue severity at week 12 using the FACIT-F scale.

How Is the Trial Designed?

Group I: Redsenol-1 Plus Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Canada Royal Enoch Phytomedicine Co., Ltd.

Lead Sponsor

Trials

1

Recruited

70+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Published Research Related to This Trial

A systematic review of seven randomized controlled trials found that ginseng significantly reduces cancer-related fatigue (CRF), with a standard mean difference of -0.21, indicating its potential effectiveness in improving patient energy levels.

Ginseng also showed improvements in physical and emotional well-being, suggesting it may enhance overall quality of life for cancer patients, although the effects can vary based on production methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Ginseng on Cancer-Related Fatigue: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Luo, WT., Huang, TW.[2023]

In a phase III trial involving 364 cancer survivors, American ginseng (2000mg daily) significantly reduced cancer-related fatigue (CRF) after 8 weeks compared to a placebo, with a notable change score of 20 versus 10.3 (P = .003).

The treatment was well-tolerated, showing no significant differences in toxicities between the ginseng and placebo groups, indicating it is a safe option for managing CRF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2. Barton, DL., Liu, H., Dakhil, SR., et al.[2022]

In a study of 30 patients with advanced renal cell carcinoma, the combination of Koujin powder and Ninjin-youeito significantly reduced general fatigue, as measured by the Cancer Fatigue Scale, indicating its potential as a supportive treatment during targeted therapy.

While the ginseng combination group showed a decrease in fatigue levels, the control group experienced an increase in fatigue, highlighting the effectiveness of the ginseng combination in managing treatment-related fatigue and potentially improving patient adherence to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[KOUJIN POWDER (RED GINSENG POWDER) WITH NINJIN-YOUEITO FOR FATIGUE DUE TO TARGETED THERAPY FOR ADVANCED RENAL CELL CARCINOMA: A RETROSPECTIVE COHORT STUDY]. Nakamura, K., Goto, Y., Sazuka, T., et al.[2019]

In a randomized double-blind trial involving 438 colorectal cancer patients, Korean red ginseng (KRG) significantly improved cancer-related fatigue (CRF) over 16 weeks compared to a placebo, particularly enhancing mood and walking ability.

While KRG was associated with a higher incidence of neutropenia, the overall rate of adverse events was similar to the placebo group, indicating that KRG can be safely combined with mFOLFOX-6 chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Korean red ginseng for cancer-related fatigue in colorectal cancer patients with chemotherapy: A randomised phase III trial. Kim, JW., Han, SW., Cho, JY., et al.[2020]

In a preliminary study involving 30 patients with cancer-related fatigue (CRF), high-dose Panax ginseng (800 mg daily for 29 days) was found to be safe, with no severe adverse events reported.

The study showed that 87% of patients experienced significant improvements in fatigue levels, as measured by the FACIT-F scale, and also reported better overall well-being and appetite, suggesting that Panax ginseng may enhance quality of life for CRF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Asian Ginseng (Panax Ginseng) for Cancer-Related Fatigue: A Preliminary Report. Yennurajalingam, S., Reddy, A., Tannir, NM., et al.[2015]

BST204, a mixture of ginsenosides, significantly improved cancer-related fatigue in mice treated with 5-fluorouracil (5-FU), as evidenced by increased running wheel activity and forced swimming times.

BST204 also enhanced muscle glycogen levels and improved blood parameters, while reducing inflammatory cytokines and liver enzymes, suggesting it may alleviate both fatigue and toxic side effects of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ginseng Purified Dry Extract, BST204, Improved Cancer Chemotherapy-Related Fatigue and Toxicity in Mice. Park, HJ., Shim, HS., Kim, JY., et al.[2022]

In a study involving 409 patients with advanced hepatocellular carcinoma, the Renshenguben (RSGB) oral solution significantly reduced cancer-related fatigue (CRF) after 8 weeks of treatment, as evidenced by lower scores on fatigue assessment scales.

The RSGB treatment was found to be safe, with no serious drug-related adverse events reported, suggesting it can be a beneficial adjunctive therapy for managing CRF in patients undergoing antitumor treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ginseng-based Renshenguben oral solution for cancer-related fatigue among patients with advanced-stage hepatocellular carcinoma: A prospective multicenter cohort study. Wang, MD., Yuan, C., Wang, KC., et al.[2023]

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Redsenol-1 Plus for Cancer-related Fatigue

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Canada Royal Enoch Phytomedicine Launches Clinical Trial

Redsenol-1 Plus featuring a remarkably high rare ginsenoside content is expected to achieve groundbreaking results in the coming clinical trial.

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The primary objective of this study is to evaluate the safety and efficacy of Redsenol-1 Plus on cancer-related fatigue (CRF) in adults.

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prnewswire.com/news-releases/canada-royal-enoch-phytomedicine-launches-clinical-trial-of-its-ginseng-derived-redsenol-1-plus-noble-ginsenoside-capsules-301720005.html

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REDSENOL-1 Plus Highly Concentrated Ginseng Extract

Redsenol-1 Plus Noble Ginsenoside Capsules contain sixteen rare ginsenosides, i.e. Rk2, Rg3, Rh2, Rg5, Rk1, Rk3, Rh1, Rh3, Rh4, aPPT, aPPD.