The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults

NCT ID: NCT05664009

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2025-06-30

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).

Conditions

Fatigue; Cancer, Treatment-Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Redsenol-1 Plus

Intervention Type: DIETARY_SUPPLEMENT

Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).

Interventions

Redsenol-1 Plus

Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Canada Royal Enoch Phytomedicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Science Inc.

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Erin Lewis, PhD

Role: CONTACT

elewis@kgkscience.com

1-226-242-4551 ext. 248

Facility Contacts

Erin Lewis, PhD

Role: primary

Other Identifiers

22EPRSZ03

Identifier Type: -

Identifier Source: org_study_id