Redsenol-1 Plus for Cancer-related Fatigue
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Redsenol-1 Plus or placebo for cancer-related fatigue, taking 6 capsules daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Redsenol-1 Plus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canada Royal Enoch Phytomedicine Co., Ltd.
Lead Sponsor
KGK Science Inc.
Industry Sponsor
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