Evaluation of the Feasibility and Safety of ENCER for Cancer Treatment-Related Fatigue in Patients Receiving Chemotherapy or Radiotherapy (CTRF)
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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Frühphase 1
Kontakte und Standorte
Studienorte
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Tel Aviv, Israel, 6971032
- Rekrutierung
- Assuta Medical Centers Ramat HaHayal
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Kontakt:
- Ravit gelbert
- Telefonnummer: +972-3-7645282
- E-Mail: ravitge@assuta.co.il
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Hauptermittler:
- merav ben david, prof
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver 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).
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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). |
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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).
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Adverse Event (AE) or Serious Adverse Events (SAE)
Zeitfenster: Weekly assessment from baseline until the end of the study at 12 weeks
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Zeitfenster: Weekly assessment from baseline until the end of the study at 12 weeks
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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.)
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Weekly assessment from baseline until the end of the study at 12 weeks
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Physiological measures using Garmin smart watch (vívosmart 5)
Zeitfenster: Weekly assessment from baseline until the end of the study at 12 weeks
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Data will be collected weekly from each patient Garmin 'vívosmart 5' smart watch, that is traced by a serial number allocated per subject.
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Weekly assessment from baseline until the end of the study at 12 weeks
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- ENC001
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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