Redsenol-1 Plus for Cancer-related Fatigue

Recruiting in Palo Alto (17 mi)

Overseen by David Crowley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Canada Royal Enoch Phytomedicine Co., Ltd.

Must not be taking: Antidepressants, Antihypertensives, others

Disqualifiers: Pregnancy, CNS malignancies, Diabetes, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing Redsenol-1 Plus to see if it can help reduce tiredness in adults with cancer. They will also check if the treatment is safe and if there are any side effects.

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.

What data supports the effectiveness of the drug Redsenol-1 Plus for cancer-related fatigue?

Research shows that ginseng, a key component in Redsenol-1 Plus, has been effective in reducing cancer-related fatigue in several studies, including trials with American ginseng and Korean red ginseng, which have shown improvements in fatigue symptoms for cancer patients. ^{1 2 3 4 5}

Is Redsenol-1 Plus safe for humans?

Research on ginseng, which is similar to Redsenol-1 Plus, suggests it is generally safe for humans. Studies have shown that ginseng can improve cancer-related fatigue without significant harmful effects. ^{1 2 3 5 6}

How is the drug Redsenol-1 Plus different from other treatments for cancer-related fatigue?

Redsenol-1 Plus is unique because it contains noble ginsenosides, which are a specific type of compound found in ginseng that may help improve energy levels and reduce fatigue. This makes it different from other treatments that may not specifically target these compounds. ^{1 2 3 5 7}

Eligibility Criteria

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.

I am able to care for myself and perform daily activities.

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

Trial Timeline

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)

Treatment Details

Interventions

• Placebo (Other)
• Redsenol-1 Plus (Dietary Supplement)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

KGK Science Inc. London, Canada

Who Is Running the Clinical Trial?

Canada Royal Enoch Phytomedicine Co., Ltd. Lead Sponsor

KGK Science Inc. Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2. [2022] Safe, effective interventions to improve cancer-related fatigue (CRF) are needed because it remains a prevalent, distressing, and activity-limiting symptom. Based on pilot data, a phase III trial was developed to evaluate the efficacy of American ginseng on CRF.

2. England pubmed.ncbi.nlm.nih.gov

Korean red ginseng for cancer-related fatigue in colorectal cancer patients with chemotherapy: A randomised phase III trial. [2020] Cancer-related fatigue (CRF) is a common symptom and has a negative impact on prognosis in cancer patients. CRF could be improved by Korean red ginseng (KRG).

3. United States pubmed.ncbi.nlm.nih.gov

High-Dose Asian Ginseng (Panax Ginseng) for Cancer-Related Fatigue: A Preliminary Report. [2015] Cancer-related fatigue (CRF) is the most common and severe symptom in patients with cancer. The number and efficacy of available treatments for CRF are limited. The objective of this preliminary study was to assess the safety of high-dose Panax ginseng (PG) for CRF.

4. Singapore 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. [2023] Cancer-related fatigue (CRF) is a common and debilitating symptom experienced by patients with advanced-stage cancer, especially those undergoing antitumor therapy. This study aimed to evaluate the efficacy and safety of Renshenguben (RSGB) oral solution, a ginseng-based traditional Chinese medicine, in alleviating CRF in patients with advanced hepatocellular carcinoma (HCC) receiving antitumor treatment.

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Ginseng on Cancer-Related Fatigue: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023] Cancer-related fatigue (CRF) is a common yet troublesome adverse effect that compromises patient quality of life (QoL). Ginseng is often used to boost energy.

6. United States pubmed.ncbi.nlm.nih.gov

Ginseng Purified Dry Extract, BST204, Improved Cancer Chemotherapy-Related Fatigue and Toxicity in Mice. [2022] Cancer related fatigue (CRF) is one of the most common side effects of cancer and its treatments. A large proportion of cancer patients experience cancer-related physical and central fatigue so new strategies are needed for treatment and improved survival of these patients. BST204 was prepared by incubating crude ginseng extract with ginsenoside-β-glucosidase. The purpose of the present study was to examine the effects of BST204, mixture of ginsenosides on 5-fluorouracil (5-FU)-induced CRF, the glycogen synthesis, and biochemical parameters in mice. The mice were randomly divided into the following groups: the naïve normal (normal), the HT-29 cell inoculated (xenograft), xenograft and 5-FU treated (control), xenograft + 5-FU + BST204-treated (100 and 200 mg/kg) (BST204), and xenograft + 5-FU + modafinil (13 mg/kg) treated group (modafinil). Running wheel activity and forced swimming test were used for evaluation of CRF. Muscle glycogen, serum inflammatory cytokines, aspartic aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CRE), white blood cell (WBC), neutrophil (NEUT), red blood cell (RBC), and hemoglobin (HGB) were measured. Treatment with BST204 significantly increased the running wheel activity and forced swimming time compared to the control group. Consistent with the behavioral data, BST204 markedly increased muscle glycogen activity and concentrations of WBC, NEUT, RBC, and HGB. Also, tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6), AST, ALT, and CRE levels in the serum were significantly reduced in the BST204-treated group compared to the control group. This result suggests that BST204 may improve chemotherapy-related fatigue and adverse toxic side effects.

7. Japan 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]. [2019] (Purpose) Targeted therapy has been standard therapeutic approach for advanced renal cell carcinoma (RCC). General fatigue is frequently observed in patients who receive targeted therapies for advanced RCC. General fatigue makes it difficult to continue a standard schedule of treatment in many cases. In this preliminary report, we explored the effect of Koujin powder (red ginseng powder) with Ninjin-youeito for general fatigue induced by targeted therapies for advanced RCC. (Material and method) The patients who complained of general fatigue during the treatment of Tyrosine Kinase Inhibitors (TKIs) as targeted therapies for advanced RCC were included in this retrospective analysis. Thirty patients with advanced RCC were enrolled from January 2016 to December 2016 at Chiba University Hospital. Twelve patients were given 3 g of Koujin powder with 9 g of Ninjin-youeito orally for two to four weeks (ginseng combination group). Eighteen patients who were not orally administered were compared as a control group (ginseng non-combination group). General fatigue was assessed with the Cancer Fatigue Scale (CFS), which divides quality of fatigue into three subgroups by using a "physical subscale", an "affective subscale", and a "cognitive subscale". We compared CFS scores at baseline and 2-8 weeks after administration. (Results) There was no statistical difference in the clinical variables between the two groups. The total CFS score was significantly decreased after treatment in the ginseng combination group (average score, 21.8 points at baseline vs 18.5 points after treatment; p=0.041). On subgroup analyses, the physical subscale score was significantly reduced after treatment in the ginseng combination group (average score, 9.7 points at baseline vs 7 points after treatment; p=0.0042). In the ginseng non-combination group, the total CFS score was significantly increased during the course (average score, 16.2 points at baseline vs 20.6 points during the course; p=0.047). On subgroup analyses, the physical subscale score was significantly increased during the course (average score, 4.4 points at baseline vs 7.3 points during the course; p=0.0042). (Conclusions) Koujin powder with Ninjin-youeito can be a therapeutic approach for general fatigue induced by targeted therapies. The precise management for general fatigue can keep patients on therapy, consequently provides a survival benefit.