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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


Phase 3
30 Years
80 Years
Open (Enrolling)
Both
Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assessment of Quality of Life

Outcome Description:

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.

Outcome Time Frame:

0 day

Safety Issue:

No

Principal Investigator

Nilson Bruno Evangelista, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lavilabor Natural Products Ltd

Authority:

Brazil: National Health Surveillance Agency

Study ID:

TK3a_FIII_Janeiro/2010

NCT ID:

NCT01168206

Start Date:

December 2010

Completion Date:

August 2012

Related Keywords:

  • Cancer

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