Cancer
Conditions
Brief summary
The association of nutritional supplement TK3 to conventional treatment of cancer patients reduces the intensity and frequency of toxic effects and side effects caused by adjuvant or palliative treatments for the protection of healthy tissues, resulting in a better quality of life.
Interventions
DIETARY_SUPPLEMENTTK3
Tritofano 160mg / Timina140mg and starch 150 mg
DIETARY_SUPPLEMENT1 capsule, 3 times per day
Placebo
Sponsors
Lavilabor Natural Products Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient Consent: Informed Consent and informed consent signed and dated by the patient (or his legal representative) and the professional who has obtained the consent. Must be delivered before inclusion. This term must be read and explained to the patient. * Patients female or male, regardless of race or color.Able to ingest oral medication. * Patients 30-80 years, with malignancy, clinical stage III or IV on chemo or hormone therapy. * Patients who have a Karnofsky level between 60 and 80.
Exclusion criteria
* no agreement to sign the Deed of Consent. * Need for use of parenteral nutrition. * The need for food supplement already approved. * Inability to receive the drug orally. * Participation in another clinical trial involving chemotherapy drugs. * Women being sexually active, which does not agree to adhere to the contraceptive methods adopted. * Women lactating * Any problem or condition that the investigator in the trial could be harmful to the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Quality of Life | 0 day | Using data from the toxicity of chemotherapy and tolerability of TK3 through the clinical course of patients with malignant CS III and IV with adjuvant or palliative chemotherapy or hormone therapy, associated or not to TK3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance status | 0 day | Karnofsky index assesses the general condition of the patient according to the level of physical performance of the patient, which assesses the degree of functional impairment by questionnaire |
| Perfomance status | 30 days | Karnofsky index assesses the general condition of the patient according to the level of physical performance of the patient, which assesses the degree of functional impairment by questionnaire |
| Performance Status | 60 days | Karnofsky index assesses the general condition of the patient according to the level of physical performance of the patient, which assesses the degree of functional impairment by questionnaire |
| Tumor Markers | 0 day | Analysis of tumor markers specific to each tumor |
Countries
Brazil
Outcome results
None listed