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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| TK3 | Experimental | 1 capsule, 3 times per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TK3 | Dietary Supplement | Tritofano 160mg / Timina140mg and starch 150 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Quality of Life | 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. | 0 day |
| Assessment of Quality of Life | 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. | 30 days |
| Assessment of Quality of Life | 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. | 60 days |
| Assessment of Quality of Life | 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. | 90 days |
| Assessment of Quality of Life | 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. | 120 days |
| Assessment of Quality of Life | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance status | 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 | 0 day |
| Perfomance status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilson Bruno Evangelista, Doctor | Lavilabor Natural Products Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sana Casa de Avaré | Recruiting | Avaré | São Paulo | 18705000 | Brazil |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 1 capsule, 3 times per day |
| Dietary Supplement |
Placebo |
|
| 150 days |
| Assessment of Quality of Life | 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. | 180 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
| 30 days |
| Performance Status | 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 | 60 days |
| Performance Status | 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 | 90 days |
| Performance Status | 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 | 120 days |
| Performance Status | 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 | 150 days |
| Performance Status | 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 | 180 days |
| Tumor Markers | Analysis of tumor markers specific to each tumor | 0 day |
| Tumor Markers | Analysis of tumor markers specific to each tumor | 30 day |
| Tumor Markers | Analysis of tumor markers specific to each tumor | 60 day |
| Tumor Markers | Analysis of tumor markers specific to each tumor | 90 day |
| Tumor Markers | Analysis of tumor markers specific to each tumor | 120 day |
| Tumor Markers | Analysis of tumor markers specific to each tumor | 150 day |
| Tumor Markers | Analysis of tumor markers specific to each tumor | 180 day |