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

12. juli 2026 opdateret af: Beaura for Para Pharmaceutical Products Trading LLC

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

74

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Israel
      • Tel Aviv, Israel, 6971032
        • Rekruttering
        • Assuta Medical Centers Ramat HaHayal
        • Kontakt:
        • Ledende efterforsker:
          • merav ben david, prof

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Encer group
Patients will be instructed on study treatment intake (2 times per day, at least six hours apart, more than 10 minutes before or after a meal, and at least three hours before going to sleep). The total amount which should be supplied to patients who completed 12 weeks of treatment is 3 boxes (a total of 180 pills, sufficient for 12 weeks).
Medicin: 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. It's based on two unconventional theories: "Like cures like"-the notion that a disease can be cured by a substance that produces similar symptoms in healthy people, and "Law of minimum dose"-the notion that the lower the dose of the medication, the greater its effectiveness.

Many homeopathic products are so diluted that no molecules of the original substance remain (Cartwright, 2018).
Placebo komparator: Placebo group
Patients will be instructed on study treatment intake (2 times per day, at least six hours apart, more than 10 minutes before or after a meal, and at least three hours before going to sleep). The total amount which should be supplied to patients who completed 12 weeks of treatment is 3 boxes (a total of 180 pills, sufficient for 12 weeks).
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse Event (AE) or Serious Adverse Events (SAE)
Tidsramme: Weekly assessment from baseline until the end of the study at 12 weeks

Adverse Event means any untoward medical occurrence associated with the treatment, whether considered related or not. An Adverse Event (AE) is any untoward medical occurrence in a subject exposed to the treatment, whether it is related to the treatment in question or not. This includes a change in a subject's condition, which has or could have a deleterious effect on the subject's health or well-being.

Chemotherapy induced AE are anticipated, and therefore any regular, possible common AE of chemotherapy such as nausea, diarrhea, mucositis, anemia, neutropenia, neuropathy or redness over the irradiated skin will be attributed to the systemic oncologic therapy.
Weekly assessment from baseline until the end of the study at 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Tidsramme: Weekly assessment from baseline until the end of the study at 12 weeks
The FACIT-F assesses chronic illness, with an emphasis on cancer therapy, cancer subtypes and symptoms. The FACIT-F is a unidimensional, 13-item scale that asks respondents to rate statements regarding their fatigue experience and its impact on their daily life. An example of items include: "I feel fatigued", "I feel weak all over", and "I feel listless (washed out)". All items are rated using a 5-point intensity rating scale (0-4). By scoring convention, after appropriate reverse scoring of 11 items, lower scores on the FACIT Fatigue subscale indicate greater levels of fatigue (and according to the scoring template available at www.facit.org.)
Weekly assessment from baseline until the end of the study at 12 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physiological measures using Garmin smart watch (vívosmart 5)
Tidsramme: Weekly assessment from baseline until the end of the study at 12 weeks
Data will be collected weekly from each patient Garmin 'vívosmart 5' smart watch, that is traced by a serial number allocated per subject.
Weekly assessment from baseline until the end of the study at 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beaura for Para Pharmaceutical Products Trading LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2025

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

5. juli 2026

Først indsendt, der opfyldte QC-kriterier

12. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • ENC001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Placeringer

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