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

Phase 3

• Conditions: Cancer
• Interventions: Dietary Supplement: TK3; Dietary Supplement: 1 capsule, 3 times per day

• Registration Number: NCT01168206
• Lead Sponsor: Lavilabor Natural Products Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Study Start: 2010-12
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-08
• Last Update Posted: 2011-09-09
• Primary Completion: 2011-12
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TK3	TK3	1 capsule, 3 times per day.
Placebo	1 capsule, 3 times per day	-

Primary Outcome Measures

Name	Time	Method
Assessment of Quality of Life	180 days	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

Name	Time	Method
Performance status	0 day	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	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
Perfomance status	30 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
Tumor Markers	180 day	Analysis of tumor markers specific to each tumor

Trial Locations

Locations (1)

Sana Casa de Avaré; 🇧🇷 Avaré, Sao Paulo, Brazil