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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01168206
• Other study ID #: TK3a_FIII_Janeiro/2010
• Status: Recruiting
• Phase: Phase 3
• First received: July 19, 2010
• Last updated: September 8, 2011
• Start date: December 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2011
• Source: Lavilabor Natural Products Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

Dietary Supplement:
• TK3
Tritofano 160mg / Timina140mg and starch 150 mg
• 1 capsule, 3 times per day
Placebo

Locations

Country	Name	City	State
Brazil	Sana Casa de Avaré	Avaré	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Lavilabor Natural Products Ltd

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Tumor Markers	Analysis of tumor markers specific to each tumor	0 day	No
Secondary	Tumor Markers	Analysis of tumor markers specific to each tumor	30 day	No
Secondary	Tumor Markers	Analysis of tumor markers specific to each tumor	60 day	No
Secondary	Tumor Markers	Analysis of tumor markers specific to each tumor	90 day	No
Secondary	Tumor Markers	Analysis of tumor markers specific to each tumor	120 day	No
Secondary	Tumor Markers	Analysis of tumor markers specific to each tumor	150 day	No
Secondary	Tumor Markers	Analysis of tumor markers specific to each tumor	180 day	No