Fatigue Related to Cancer TreatmentEarly Phase 1CTRFNCT07707648
Evaluation of the Feasibility and Safety of ENCER for Cancer Treatment-Related Fatigue in Patients Receiving Chemotherapy or Radiotherapy
A Early Phase 1 study testing encer in people with Fatigue Related to Cancer Treatment, run by Beaura for Para Pharmaceutical Products Trading LLC at 1 site in Israel.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue Related to Cancer Treatment
- What is being tested?
- encer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2025to 21 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Fatigue Related to Cancer Treatment
- Being tested
- encer, Placebo
- Keywords
- cancer treatment related fatigue, homeopathy medicine for fatigue related to cancer treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
encerDrug
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).
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Encer group | Active comparator | 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). Receives: Drug: encer |
| Placebo group | Placebo comparator | 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE) or Serious Adverse Events (SAE)
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.
Measured: Weekly assessment from baseline until the end of the study at 12 weeks
Secondary outcomes (1)
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
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.)
Measured: Weekly assessment from baseline until the end of the study at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Oct 2025
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Related to Cancer TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- As this is a double blind, placebo-controlled clinical study design, patients will be randomized in a 1:1 ratio to arm 1 or arm 2.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaura for Para Pharmaceutical Products Trading LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707648
- Sponsor's protocol ID
- ENC001
- Acronym
- CTRF
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Double Blind, Placebo-controlled Clinical Study Designed to Evaluate the Effect of 'Encer' on Cancer Treatment Related Fatigue
- ClinicalTrials.gov ID
- NCT07707648
- Acronym / sponsor ID
- CTRF / ENC001
- Conditions
- Fatigue Related to Cancer Treatment
- Keywords
- cancer treatment related fatigue, homeopathy medicine for fatigue related to cancer treatments
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Beaura for Para Pharmaceutical Products Trading LLCUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- As this is a double blind, placebo-controlled clinical study design, patients will be randomized in a 1:1 ratio to arm 1 or arm 2.
| Arm | Type | Receives |
|---|---|---|
| Encer group | Active comparator | Drug: encerPatients 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). |
| Placebo group | Placebo comparator | Drug: PlaceboPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| encerHomeopathy 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). | Drug | Encer group |
| PlaceboPlacebo 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. | Drug | Placebo group |
Primary outcome
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.
1 secondary outcome
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Weekly assessment from baseline until the end of the study at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing encer in people with Fatigue Related to Cancer Treatment, run by Beaura for Para Pharmaceutical Products Trading LLC at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AE) or Serious Adverse Events (SAE) (time frame: Weekly assessment from baseline until the end of the study at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.