Evaluation of TK3 in Improving Quality of Life in Patients With Malignancy Under Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Quality of Life and the Toxicity of Chemotherapy in Patients With Malignancies in Clinical Stages III and IV Under Palliative Treatment With Chemotherapy or Hormone Therapy With or Without Nutritional Supplement TK3

Conditions
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Cancer

Intervention / Treatment
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* Dietary Supplement: TK3
* Dietary Supplement: 1 capsule, 3 times per day


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: 1 capsule, 3 times per day<br>* Placebo<br>|
| Experimental: TK3<br>1 capsule, 3 times per day. | Dietary Supplement: TK3<br>* Tritofano 160mg / Timina140mg and starch 150 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |