Evaluation of the Feasibility and Safety of ENCER for Cancer Treatment-Related Fatigue in Patients Receiving Chemotherapy or Radiotherapy

Официальное название

A Feasibility, Double Blind, Placebo-controlled Clinical Study Designed to Evaluate the Effect of 'Encer' on Cancer Treatment Related Fatigue

Обзор

This is a feasibility, double blind, placebo-controlled clinical study designed to evaluate the effect of 'Encer' on Cancer treatment Related Fatigue. 'Encer' is a combination of 5 Homeopathic Medical Product (HMP). The five HMPs are registered in the Homeopathic Pharmacopeia of the United States and the current investigational treatment 'Encer' is authorized for over-the-counter sales in the USA by NDC number. The study aims to test the efficacy of 'Encer' in treating Cancer Treatment-Related Fatigue (CTRF) among cancer patients treated with chemotherapy and or radiotherapy using the Physiological measurements using Garmin vivosmart 5 and the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-F). This feasibility study will include patients that will be randomly assigned to either Placebo or Treatment in 1:1 ratio.

Вмешательства

• Препарат encer
  Homeopathy is one of the most commonly used complementary therapies along with herbs and vitamins in 7 out of 14 European countries, and an average 31.4% of cancer patients in those countries use Homeopathy. The use of homeopathy in patients with cancer has been associated with an improvement in Quality of life (QOL) and a decrease in fatigue symptoms (Medioni et al., 2023). Homeopathy, also known as homeopathic medicine, is a medical system that was developed in Germany more than 200 years ago.
• Препарат Placebo
  Placebo tablets identical in appearance, taste, and administration schedule to ENCER, but containing only inactive ingredients and no homeopathic active ingredients. Participants received one tablet orally twice daily for 12 weeks.

Первичные конечные точки

• Adverse Event (AE) or Serious Adverse Events (SAE) [Срок оценки: Weekly assessment from baseline until the end of the study at 12 weeks]

Вторичные конечные точки (1)

• Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Срок оценки: Weekly assessment from baseline until the end of the study at 12 weeks]

Критерии участия

Критерии включения

• Subject's informed consent
• Either male or female
• Age 18 and above
• Diagnosed with cancer (any type of solid tumor)
• Patients planned for their initial treatment or a new regimen of chemotherapy, (at least 4 treatments planned within 12 weeks) a new regimen of radiotherapy (at least 15 fractions planned)
• Able to interface with digital questionnaire sent to the patient electronically
• Willing to wear a smartwatch that will detect physiological measurements for the duration of the trial
• Not currently treated with homeopathic remedy (for at least one week prior to study treatment)

Критерии исключения

• Unable to give informed consent
• Planned Radiotherapy for less than 15 fractions
• Chemotherapy anticipated for less than 12 weeks, or fewer than 4 treatments
• Life expectancy of less than 3 months
• Patient is a dependent of the sponsor, of the investigational team or his/her immediate family
• Pregnant or nursing women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Израиль · 1 центр

• Assuta Medical Centers Ramat HaHayal — Tel Aviv

Идентификаторы

NCT: NCT07707648 · ENC001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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