Clinical trial NCT05664009: The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Fatigue
Cancer, Treatment-Related
Keywords: Safety and efficacy
Cancer-related fatigue
Ginseng
Lead sponsor: Canada Royal Enoch Phytomedicine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2022-12-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: The change in the severity of cancer-related fatigue from baseline to week 12.
timeFrame: baseline and 84 days
Secondary outcomes:
measure: The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.
timeFrame: baseline, 28 days, 56 days
measure: The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
timeFrame: baseline, 28 days, 56 days, 84 days
measure: The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
timeFrame: baseline, 28 days, 56 days, 84 days
measure: The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
timeFrame: baseline, 28 days, 56 days, 84 days
measure: The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
timeFrame: baseline, 28 days, 56 days, 84 days
measure: The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
timeFrame: baseline, 28 days, 56 days, 84 days
measure: 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.
timeFrame: baseline, 28 days, 56 days, 84 days
measure: The difference in performance status from baseline to weeks 4, 8, and 12.
timeFrame: baseline, 28 days, 56 days, 84 days
measure: The difference in mood from baseline to weeks 4, 8, and 12.
timeFrame: baseline, 28 days, 56 days, 84 days
measure: Incidence of pre-emergent and post-emergent adverse events following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Blood pressure at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Heart rate at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Aspartate aminotransferase (AST) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Alanine aminotransferase (ALT) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Alkaline phosphatase (ALP) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Bilirubin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Creatinine measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Measurement of electrolytes (Na, K ,Cl) following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Measurement of glucose following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Estimated glomerular filtration rate (eGFR) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: White blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Red blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Hematocrit measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Platelet count measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Mean corpuscular volume measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Mean corpuscular hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Mean corpuscular hemoglobin concentration measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Red blood cell distribution width measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Immature granulocyte measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Nucleated red blood cell measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
timeFrame: 84 days
measure: Incidence of adverse events during the follow-up period (weeks 12-16).
timeFrame: 112 days
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: