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Безопасность и эффективность Redsenol-1 Plus при утомляемости, связанной с раком, у взрослых, получавших лечение рака

23 сентября 2026 г. обновлено: Canada Royal Enoch Phytomedicine Co., Ltd.

Рандомизированное, тройное слепое, плацебо-контролируемое, параллельное клиническое исследование для изучения безопасности и эффективности Redsenol-1 Plus при усталости, связанной с раком, у взрослых, получавших лечение рака

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).

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

72

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Erin Lewis, PhD
  • Номер телефона: 248 1-226-242-4551
  • Электронная почта: elewis@kgkscience.com

Места учебы

  • Канада
    • Ontario
      • London, Ontario, Канада, N6B 3L1
        • Рекрутинг
        • KGK Science Inc.
        • Контакт:
          • Erin Lewis, PhD

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Диетическая добавка: Redsenol-1 Plus

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

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
The change in the severity of cancer-related fatigue from baseline to week 12.
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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).
Временное ограничение: 112 days

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Canada Royal Enoch Phytomedicine Co., Ltd.

Соавторы

KGK Science Inc.

Следователи

  • Главный следователь: David Crowley, MD, KGK Science Inc.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

30 августа 2026 г.

Первичное завершение (Оцененный)

1 декабря 2027 г.

Завершение исследования (Оцененный)

1 декабря 2027 г.

Даты регистрации исследования

Первый отправленный

8 декабря 2022 г.

Впервые представлено, что соответствует критериям контроля качества

15 декабря 2022 г.

Первый опубликованный (Действительный)

23 декабря 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

28 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

23 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 22EPRSZ03

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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