Evaluation of TK3 in Improving Quality of Life in Patients With Malignancy Under Chemotherapy
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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 cancer
Started Dec 2010
Shorter than P25 for phase_3 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 9, 2011
September 1, 2011
1 year
July 19, 2010
September 8, 2011
Conditions
Outcome Measures
Primary Outcomes (7)
Assessment of Quality of Life
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.
0 day
Assessment of Quality of Life
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.
30 days
Assessment of Quality of Life
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.
60 days
Assessment of Quality of Life
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.
90 days
Assessment of Quality of Life
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.
120 days
Assessment of Quality of Life
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.
150 days
Assessment of Quality of Life
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.
180 days
Secondary Outcomes (14)
Performance status
0 day
Perfomance status
30 days
Performance Status
60 days
Performance Status
90 days
Performance Status
120 days
- +9 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORTK3
EXPERIMENTAL1 capsule, 3 times per day.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sana Casa de Avaré
Avaré, São Paulo, 18705000, Brazil
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Nilson Bruno Evangelista, Doctor
Lavilabor Natural Products Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2010
First Posted
July 23, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2011
Study Completion
August 1, 2012
Last Updated
September 9, 2011
Record last verified: 2011-09