CancerPhase 3NCT01168206
Evaluation of TK3 in Improving Quality of Life in Patients With Malignancy Under Chemotherapy
A Phase 3 study testing TK3 and 1 capsule, 3 times per day in people with Cancer, run by Lavilabor Natural Products Ltd at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- TK3 and 1 capsule, 3 times per day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2010to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Sana Casa de Avaré
Avaré, São Paulo, 18705000
Nilson Bruno Evangelista, Doctor, +551437119100, smaadm@bol.com.br
About this study
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
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.
- Conditions
- Cancer
- Being tested
- TK3, 1 capsule, 3 times per day
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TK3Dietary supplement
Tritofano 160mg / Timina140mg and starch 150 mg
1 capsule, 3 times per dayDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: 1 capsule, 3 times per day |
| TK3 | Experimental | 1 capsule, 3 times per day. Receives: Dietary Supplement: TK3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 days
Secondary outcomes (14)
Performance status
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
Measured: 0 day
Perfomance status
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
Measured: 30 days
Performance Status
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
Measured: 60 days
Performance Status
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
Measured: 90 days
Performance Status
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
Measured: 120 days
Performance Status
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
Measured: 150 days
Performance Status
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
Measured: 180 days
Tumor Markers
Analysis of tumor markers specific to each tumor
Measured: 0 day
Tumor Markers
Analysis of tumor markers specific to each tumor
Measured: 30 day
Tumor Markers
Analysis of tumor markers specific to each tumor
Measured: 60 day
Tumor Markers
Analysis of tumor markers specific to each tumor
Measured: 90 day
Tumor Markers
Analysis of tumor markers specific to each tumor
Measured: 120 day
Tumor Markers
Analysis of tumor markers specific to each tumor
Measured: 150 day
Tumor Markers
Analysis of tumor markers specific to each tumor
Measured: 180 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lavilabor Natural Products Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nilson Bruno Evangelista, Doctor, Principal investigator, Lavilabor Natural Products Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168206
- Sponsor's protocol ID
- TK3a_FIII_Janeiro/2010
- Status last verified
- Sep 2011
- First submitted
- 19 Jul 2010
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01168206
- Acronym / sponsor ID
- TK3a_FIII_Janeiro/2010
- Conditions
- Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lavilabor Natural Products LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 23 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: 1 capsule, 3 times per day |
| TK3 | Experimental | Dietary Supplement: TK31 capsule, 3 times per day. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TK3Tritofano 160mg / Timina140mg and starch 150 mg | Dietary supplement | TK3 |
| 1 capsule, 3 times per dayPlacebo | Dietary supplement | Placebo |
Primary outcome
Assessment of Quality of Life
Time frame: 0 day
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
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
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
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
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
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
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.
14 secondary outcomes
Performance status
Time frame: 0 day
Perfomance status
Time frame: 30 days
Performance Status
Time frame: 60 days
Performance Status
Time frame: 90 days
Performance Status
Time frame: 120 days
Performance Status
Time frame: 150 days
Performance Status
Time frame: 180 days
Tumor Markers
Time frame: 0 day
Tumor Markers
Time frame: 30 day
Tumor Markers
Time frame: 60 day
Tumor Markers
Time frame: 90 day
Tumor Markers
Time frame: 120 day
Tumor Markers
Time frame: 150 day
Tumor Markers
Time frame: 180 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilson Bruno Evangelista, Doctor principal investigator
Lavilabor Natural Products Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TK3 and 1 capsule, 3 times per day in people with Cancer, run by Lavilabor Natural Products Ltd at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Quality of Life (time frame: 0 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.