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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Dietary supplement: 1 capsule, 3 times per day; Dietary supplement: TK3

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Avaré, Sao Paulo, Brazil, 18705000
      • Recruiting
      • Sana Casa de Avaré
      • Contact: Nilson Bruno Evangelista, Doctor; Phone Number: +551437119100; Email: smaadm@bol.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: 1 capsule, 3 times per day; Placebo
Experimental: TK3; 1 capsule, 3 times per day.	Dietary supplement: TK3; Tritofano 160mg / Timina140mg and starch 150 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lavilabor Natural Products Ltd
• Investigators: Principal Investigator: Nilson Bruno Evangelista, Doctor, Lavilabor Natural Products Ltd

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 23, 2010

Study Record Updates

• Last Update Posted (Estimate): September 9, 2011
• Last Update Submitted That Met QC Criteria: September 8, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: TK3a_FIII_Janeiro/2010