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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Lavilabor Natural Products Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lavilabor Natural Products Ltd
ClinicalTrials.gov Identifier:
NCT01168206
First received: July 19, 2010
Last updated: September 8, 2011
Last verified: September 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014