72 Participants Needed

Redsenol-1 Plus for Cancer-related Fatigue

EL
Overseen ByErin Lewis, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Canada Royal Enoch Phytomedicine Co., Ltd.
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.13678

Who Is on the Research Team?

KGK Science – Dr. Crowley - JoinAStudy.ca

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
See 6 more

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
See 15 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Redsenol-1 PlusExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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.
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.
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.
[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]

Citations

Redsenol-1 Plus for Cancer-related FatigueResearch shows that ginseng, a key component in Redsenol-1 Plus, has been effective in reducing cancer-related fatigue in several studies, including trials with ...
Canada Royal Enoch Phytomedicine Launches Clinical TrialRedsenol-1 Plus featuring a remarkably high rare ginsenoside content is expected to achieve groundbreaking results in the coming clinical trial.
Ginsenoside Supplement Redsenol-1 Plus Included in ...The trial is designed to evaluate the efficacy of Redsenol-1 Plus in mitigating cancer-related fatigue, a common and debilitating symptom ...
The Safety and Efficacy of Redsenol-1 Plus on Cancer-related ...The primary objective of this study is to evaluate the safety and efficacy of Redsenol-1 Plus on cancer-related fatigue (CRF) in adults.
Canada Royal Enoch Phytomedicine Launches Clinical ...Clinical trial will examine Redsenol-1 Plus efficacy for cancer-related fatigue. VANCOUVER, BC, Jan. 12, 2023 /PRNewswire/ -- Canada Royal ...
Ginsenoside Supplement Redsenol-1 Plus Included in ...The success of this trial could position Redsenol-1 Plus as a groundbreaking solution for cancer-related fatigue. About Canada Royal Enoch ...
Investigating the Effects of Oral Ginseng on the Cancer- ...The fatigue, faint, and disability are observed in 59 % of cancer patients who finished their chemotherapy sessions and 65-100 % of the patients who are under ...
REDSENOL-1 Plus Highly Concentrated Ginseng ExtractRedsenol-1 Plus Noble Ginsenoside Capsules contain sixteen rare ginsenosides, i.e. Rk2, Rg3, Rh2, Rg5, Rk1, Rk3, Rh1, Rh3, Rh4, aPPT, aPPD.
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