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L'innocuité et l'efficacité de Redsenol-1 Plus sur la fatigue liée au cancer chez les adultes ayant reçu un traitement contre le cancer

23 septembre 2026 mis à jour par: Canada Royal Enoch Phytomedicine Co., Ltd.

Un essai clinique randomisé, en triple aveugle, contrôlé par placebo et parallèle pour étudier l'innocuité et l'efficacité de Redsenol-1 Plus sur la fatigue liée au cancer chez les adultes ayant reçu un traitement contre le cancer

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).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

72

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

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

  9. 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, gastrointestinal disease or symptoms that can affect nutritional balance)
  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 5.4.1 and 5.4.2)
  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 inclusive of thyroid stimulating hormone 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Complément alimentaire: Redsenol-1 Plus

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

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The change in the severity of cancer-related fatigue from baseline to week 12.
Délai: baseline and 84 days

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.
Délai: baseline, 28 days, 56 days

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.
Délai: 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 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.
Délai: 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 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.
Délai: 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 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.
Délai: 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 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.
Délai: 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 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.
Délai: 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 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.
Délai: baseline, 28 days, 56 days, 84 days

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.
Délai: baseline, 28 days, 56 days, 84 days

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
Incidence of pre-emergent and post-emergent adverse events following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Délai: 84 days

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.
Délai: baseline, 4 weeks, 8 weeks, 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.
Délai: baseline, 4 weeks, 8 weeks, 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
Aspartate aminotransferase (AST) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

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.
Délai: 84 days

Nucleated red blood cells will be measured in blood from study participants at 12 weeks.
84 days
Incidence of adverse events during the follow-up period (weeks 12-16).
Délai: 112 days

Incidence of adverse events during the 4-week follow-up period (weeks 12-16).
112 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Canada Royal Enoch Phytomedicine Co., Ltd.

Collaborateurs

KGK Science Inc.

Les enquêteurs

  • Chercheur principal: David Crowley, MD, KGK Science Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 août 2026

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

8 décembre 2022

Première soumission répondant aux critères de contrôle qualité

15 décembre 2022

Première publication (Réel)

23 décembre 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 22EPRSZ03

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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