Clinical trial NCT01168206: Evaluation of TK3 in Improving Quality of Life in Patients With Malignancy Under Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer
Lead sponsor: Lavilabor Natural Products Ltd
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Assessment of Quality of Life
timeFrame: 0 day
measure: Assessment of Quality of Life
timeFrame: 30 days
measure: Assessment of Quality of Life
timeFrame: 60 days
measure: Assessment of Quality of Life
timeFrame: 90 days
measure: Assessment of Quality of Life
timeFrame: 120 days
measure: Assessment of Quality of Life
timeFrame: 150 days
measure: Assessment of Quality of Life
timeFrame: 180 days
Secondary outcomes:
measure: Performance status
timeFrame: 0 day
measure: Perfomance status
timeFrame: 30 days
measure: Performance Status
timeFrame: 60 days
measure: Performance Status
timeFrame: 90 days
measure: Performance Status
timeFrame: 120 days
measure: Performance Status
timeFrame: 150 days
measure: Performance Status
timeFrame: 180 days
measure: Tumor Markers
timeFrame: 0 day
measure: Tumor Markers
timeFrame: 30 day
measure: Tumor Markers
timeFrame: 60 day
measure: Tumor Markers
timeFrame: 90 day
measure: Tumor Markers
timeFrame: 120 day
measure: Tumor Markers
timeFrame: 150 day
measure: Tumor Markers
timeFrame: 180 day
Other outcomes:
Locations:
city: Avaré
country: Brazil
facility: Sana Casa de Avaré
state: Sao Paulo
Study officials:
affiliation: Lavilabor Natural Products Ltd
name: Nilson Bruno Evangelista, Doctor
role: PRINCIPAL_INVESTIGATOR
References: