Evaluating Redsenol-1 Plus for 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

This study is testing if a new treatment called Redsenol-1 Plus can help adults with cancer-related fatigue feel better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Canada Royal Enoch Phytomedicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (London, Ontario)
• Trial ID: NCT05664009 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of Redsenol-1 Plus in alleviating cancer-related fatigue (CRF) in adults. Participants will be randomly assigned to receive either Redsenol-1 Plus or a placebo, with their fatigue levels measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at baseline and after 12 weeks. The study will also monitor any adverse events to evaluate the tolerability of the treatment compared to the placebo group.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older experiencing cancer-related fatigue.

Not a fit: Patients who are not experiencing cancer-related fatigue or those with contraindications to the study medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce cancer-related fatigue, improving the quality of life for patients undergoing cancer treatment.

How similar studies have performed: While there have been studies on fatigue management in cancer patients, the specific use of Redsenol-1 Plus is a novel approach that has not been extensively tested.

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.

Where this trial is running

London, Ontario

• KGK Science Inc. — London, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: David Crowley, MD — KGK Science Inc.
• Study coordinator: Erin Lewis, PhD

Conditions Fatigue; Cancer, Treatment-Related; Safety and efficacy; Cancer-related fatigue; Ginseng