Evaluation of TK3 in Improving Quality of Life in Patients With Malignancy Under Chemotherapy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cancer	Dietary Supplement: TK3 Dietary Supplement: 1 capsule, 3 times per day	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Palliative Care

U.S. FDA Resources

Further study details as provided by Lavilabor Natural Products Ltd:

Primary Outcome Measures:

Assessment of Quality of Life [ Time Frame: 0 day ] [ Designated as safety issue: No ]
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.
Assessment of Quality of Life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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.
Assessment of Quality of Life [ Time Frame: 60 days ] [ Designated as safety issue: No ]
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.
Assessment of Quality of Life [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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.
Assessment of Quality of Life [ Time Frame: 120 days ] [ Designated as safety issue: No ]
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.
Assessment of Quality of Life [ Time Frame: 150 days ] [ Designated as safety issue: No ]
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.
Assessment of Quality of Life [ Time Frame: 180 days ] [ Designated as safety issue: No ]
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 Outcome Measures:

Performance status [ Time Frame: 0 day ] [ Designated as safety issue: No ]
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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 60 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 120 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 150 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 180 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 0 day ] [ Designated as safety issue: No ]
Analysis of tumor markers specific to each tumor
Tumor Markers [ Time Frame: 30 day ] [ Designated as safety issue: No ]
Analysis of tumor markers specific to each tumor
Tumor Markers [ Time Frame: 60 day ] [ Designated as safety issue: No ]
Analysis of tumor markers specific to each tumor
Tumor Markers [ Time Frame: 90 day ] [ Designated as safety issue: No ]
Analysis of tumor markers specific to each tumor
Tumor Markers [ Time Frame: 120 day ] [ Designated as safety issue: No ]
Analysis of tumor markers specific to each tumor
Tumor Markers [ Time Frame: 150 day ] [ Designated as safety issue: No ]
Analysis of tumor markers specific to each tumor
Tumor Markers [ Time Frame: 180 day ] [ Designated as safety issue: No ]
Analysis of tumor markers specific to each tumor

Estimated Enrollment:	80
Study Start Date:	December 2010
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168206

Locations

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

Sponsors and Collaborators

Lavilabor Natural Products Ltd

Investigators

Principal Investigator:

Nilson Bruno Evangelista, Doctor

Lavilabor Natural Products Ltd

More Information

No publications provided

Responsible Party:	Lavilabor Natural Products Ltd
ClinicalTrials.gov Identifier:	NCT01168206 History of Changes
Other Study ID Numbers:	TK3a_FIII_Janeiro/2010
Study First Received:	July 19, 2010
Last Updated:	September 8, 2011
Health Authority:	Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 19, 2013