Status:
UNKNOWN
Evaluation of TK3 in Improving Quality of Life in Patients With Malignancy Under Chemotherapy
Lead Sponsor:
Lavilabor Natural Products Ltd
Conditions:
Cancer
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01168206
Start Date
December 1 2010
End Date
August 1 2012
Last Update
September 9 2011
Active Locations (1)
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1
Sana Casa de Avaré
Avaré, São Paulo, Brazil, 18705000