Fatigue Related to Cancer Treatment
Conditions
Keywords
cancer treatment related fatigue, homeopathy medicine for fatigue related to cancer treatments
Brief 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.
Interventions
DRUGencer
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).
DRUGPlacebo
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.
Sponsors
Beaura for Para Pharmaceutical Products Trading LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event (AE) or Serious Adverse Events (SAE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | 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.) |
Countries
Israel
Outcome results
None listed