Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07707648

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Fatigue Related to Cancer Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Assuta Medical Centers Ramat HaHayal

Tel Aviv, 6971032, Israel

Location status: Recruiting

Location contact

Ravit gelbert

CONTACT

[email protected]

+972-3-7645282

merav ben david, prof

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

encer

Drug

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

Drug

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 outcomes

  1. Adverse Event (AE) or Serious Adverse Events (SAE)

    Time frame: 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.

Secondary outcomes

  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

    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.)

Other outcomes

  1. Physiological measures using Garmin smart watch (vívosmart 5)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beaura for Para Pharmaceutical Products Trading LLC

Other

Registry information

Official study title

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

Acronym: CTRF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.