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

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). 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.

Eligibility

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

Conditions2

Interventions1

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