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 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).

Study Overview

• Status: Recruiting
• Conditions: Fatigue; Cancer, Treatment-Related
• Intervention / Treatment: Dietary supplement: Redsenol-1 Plus; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Erin Lewis, PhD; Phone Number: 248 1-226-242-4551; Email: elewis@kgkscience.com

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6B 3L1
      • Recruiting
      • KGK Science Inc.
      • Contact: Erin Lewis, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females ≥18 years of age.

2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

   Or,

   Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

   • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
   • Double-barrier method
   • Intrauterine devices
   • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
   • Vasectomy of partner at least 6 months prior to screening
3. Individuals previously diagnosed with cancer and have CRF defined as a score of ≥4 on the CRF Single-Item Scale (an 11-point scale where 0 is "no fatigue" and 10 is "as bad as it can be")
4. CRF present for at least one month prior to screening
5. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤2
6. Hemoglobin level of ≥110 g/L for females and ≥129 g/L for males at screening
7. Agrees to maintain current lifestyle habits as much as possible throughout the study depending on ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period

9. Provided voluntary, written, informed consent to participate in the study

10. Otherwise healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI) while taking into consideration the participant's cancer history

Exclusion Criteria:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy, sensitivity, or intolerance to the investigational product's or placebo's active or inactive ingredients
3. Individuals with any CNS malignancies (e.g., brain or spine) and/or estrogen-receptor positive breast cancer
4. Individuals with other primary causes of fatigue, as assessed by the QI (e.g., diagnosed non-cancer related chronic pain, insomnia/sleep disorders, depression/psychiatric disorders, unstable hypothyroidism, diabetes)
5. Individuals with unstable medical conditions as assessed by the QI
6. Individuals with current untreated/uncontrolled high blood pressure or tachycardia/heart rhythm disorders
7. Individuals with >7.5% HbA1c with treatment for high blood sugar/diabetes or individuals with ≥6.5% HbA1c without treatment
8. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
9. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
10. Major non-cancer surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
11. Current use of prescription/OTC medications and/or supplements and food/drinks which may affect the efficacy and/ or safety of the IP (see Sections 7.3.1 and 7.3.2)
12. Alcohol or drug abuse within the last 12 months
13. Frequent (daily) and chronic cannabis users. Occasional (e.g., once per month) cannabis users may be included at the discretion of the QI and if eligible, asked to stop cannabis use for study period
14. Clinically significant abnormal laboratory results at screening as assessed by the QI
15. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
16. Individuals who are unable to give informed consent
17. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
18. Individuals who are on active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, target therapy), have completed cancer treatment within one month of baseline, and/or are scheduled to receive further treatment during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Redsenol-1 Plus; 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.	Dietary supplement: Redsenol-1 Plus; Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).
Placebo Comparator: Placebo; 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.	Other: Placebo; Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the severity of cancer-related fatigue from baseline to week 12.	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.	baseline and 84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.	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.	baseline, 28 days, 56 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.	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.	baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.	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.	baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.	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.	baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.	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.	baseline, 28 days, 56 days, 84 days
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.	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.	baseline, 28 days, 56 days, 84 days
The difference in the proportion of participants who have a clinically important change in severity of cancer-related fatigue from baseline to 4 weeks, 8 weeks, and 12 weeks.	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.	baseline, 28 days, 56 days, 84 days
The difference in performance status from baseline to weeks 4, 8, and 12.	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.	baseline, 28 days, 56 days, 84 days
The difference in mood from baseline to weeks 4, 8, and 12.	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.	baseline, 28 days, 56 days, 84 days
Aspartate aminotransferase (AST) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Aspartate aminotransferase (AST) will be measured in blood from study participants at 12 weeks.	84 days
Alanine aminotransferase (ALT) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Alanine aminotransferase (ALT) will be measured in blood from study participants at 12 weeks.	84 days
Alkaline phosphatase (ALP) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Alkaline phosphatase (ALP) will be measured in blood from study participants at 12 weeks.	84 days
Bilirubin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Total bilirubin will be measured in blood from study participants at 12 weeks.	84 days
Creatinine measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Creatinine will be measured in blood from study participants at 12 weeks.	84 days
Measurement of electrolytes (Na, K ,Cl) following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Electrolytes will be measured in blood from study participants at 12 weeks.	84 days
Measurement of glucose following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Glucose will be measured in blood from study participants at 12 weeks.	84 days
Estimated glomerular filtration rate (eGFR) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Estimated glomerular filtration rate (eGFR) will be measured in blood from study participants at 12 weeks.	84 days
White blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	White blood cell count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils) will be measured in blood from study participants at 12 weeks.	84 days
Red blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Red blood cell count will be measured in blood from study participants at 12 weeks.	84 days
Hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Hemoglobin will be measured in blood from study participants at 12 weeks.	84 days
Hematocrit measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Hematocrit will be measured in blood from study participants at 12 weeks.	84 days
Platelet count measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Platelet count will be measured in blood from study participants at 12 weeks.	84 days
Mean corpuscular volume measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Mean corpuscular volume will be measured in blood from study participants at 12 weeks.	84 days
Mean corpuscular hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Mean corpuscular hemoglobin will be measured in blood from study participants at 12 weeks.	84 days
Mean corpuscular hemoglobin concentration measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Mean corpuscular hemoglobin concentration will be measured in blood from study participants at 12 weeks.	84 days
Red blood cell distribution width measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Red blood cell distribution will be measured in blood from study participants at 12 weeks.	84 days
Immature granulocyte measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Immature granulocytes will be measured in blood from study participants at 12 weeks.	84 days
Nucleated red blood cell measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	Nucleated red blood cells will be measured in blood from study participants at 12 weeks.	84 days
Incidence of pre-emergent and post-emergent adverse events following supplementation with Redsenol-1 Plus or placebo for 12 weeks.	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.	84 days
Blood pressure at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.	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.	baseline, 4 weeks, 8 weeks, 12 weeks
Heart rate at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.	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.	baseline, 4 weeks, 8 weeks, 12 weeks
Incidence of adverse events during the follow-up period (weeks 12-16).	Incidence of adverse events during the 4-week follow-up period (weeks 12-16).	112 days

Collaborators and Investigators

• Sponsor: Canada Royal Enoch Phytomedicine Co., Ltd.
• Collaborators: KGK Science Inc.
• Investigators: Principal Investigator: David Crowley, MD, KGK Science Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Safety and efficacy; Ginseng; Cancer-related fatigue
• Additional Relevant MeSH Terms: Neoplasms; Fatigue; Neoplasms, Second Primary
• Other Study ID Numbers: 22EPRSZ03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No