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

NCT05664009 | Recruiting Phase 2

• 1 other identifier: 22EPRSZ03
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

Safety and efficacy; Cancer-related fatigue; Ginseng

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.

  baseline, 28 days, 56 days

• The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.

  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.

  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.

  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.

  baseline, 28 days, 56 days, 84 days

Study Arms (2)

Redsenol-1 Plus

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Redsenol-1 Plus DIETARY_SUPPLEMENT

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

Redsenol-1 Plus

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥18 years of age.
• 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
• 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")
• CRF present for at least one month prior to screening
• Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤2
• Hemoglobin level of ≥110 g/L for females and ≥129 g/L for males at screening
• 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
• \. Provided voluntary, written, informed consent to participate in the study

You may not qualify if:

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, or intolerance to the investigational product's or placebo's active or inactive ingredients
• Individuals with any CNS malignancies (e.g., brain or spine) and/or estrogen-receptor positive breast cancer
• 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)
• Individuals with unstable medical conditions as assessed by the QI
• Individuals with current untreated/uncontrolled high blood pressure or tachycardia/heart rhythm disorders
• Individuals with \>7.5% HbA1c with treatment for high blood sugar/diabetes or individuals with ≥6.5% HbA1c without treatment
• 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
• 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
• 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
• 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)
• Alcohol or drug abuse within the last 12 months
• 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
• Clinically significant abnormal laboratory results at screening as assessed by the QI
• Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI

Sponsors & Collaborators

• Canada Royal Enoch Phytomedicine Co., Ltd.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B 3L1, Canada

RECRUITING

MeSH Terms

Conditions

Fatigue; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Lewis, PhD

CONTACT

1-226-242-4551; elewis@kgkscience.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 23, 2022
• Study Start: May 30, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)