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Recruiting NCT07707648

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

Early Phase I Interventional Fatigue Related to Cancer Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: encer, Placebo.
Who it may be relevant to
Registry conditions: Fatigue Related to Cancer Treatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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.
  • Drug 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.

Primary outcome measures

  • Adverse Event (AE) or Serious Adverse Events (SAE) [Time frame: Weekly assessment from baseline until the end of the study at 12 weeks]
Secondary outcome measures (1)
  • Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Time frame: Weekly assessment from baseline until the end of the study at 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

Israel · 1 center
  • Assuta Medical Centers Ramat HaHayal — Tel Aviv

Identifiers

NCT: NCT07707648 · ENC001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗