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

RecruitingEARLY Phase 1Ages 18 Years - anyAllBeaura for Para Pharmaceutical Products Trading L…
NCT07707648 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Subject's informed consent 2. Either male or female 3. Age 18 and above 4. Diagnosed with cancer (any type of solid tumor) 5. 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) 6. Able to interface with digital questionnaire sent to the patient electronically 7. Willing to wear a smartwatch that will detect physiological measurements for the duration of the trial 8. Not currently treated with homeopathic remedy (for at least one week prior to study treatment) Exclusion Criteria: 1. Unable to give informed consent 2. Planned Radiotherapy for less than 15 fractions 3. Chemotherapy anticipated for less than 12 weeks, or fewer than 4 treatments 4. Life expectancy of less than 3 months 5. Patient is a dependent of the sponsor, of the investigational team or his/her immediate family 6. Pregnant or nursing women
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What it tests

  • encer
  • Placebo
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Where

1 site
Assuta Medical Centers Ramat HaHayal
Tel Aviv, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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