Evaluation of TK3 in Improving Quality of Life in Patients With Malignancy Under Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

1 capsule, 3 times per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

TK3

1 capsule, 3 times per day.

Group Type EXPERIMENTAL

TK3

Intervention Type DIETARY_SUPPLEMENT

Tritofano 160mg / Timina140mg and starch 150 mg

Interventions

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TK3

Tritofano 160mg / Timina140mg and starch 150 mg

Intervention Type DIETARY_SUPPLEMENT

1 capsule, 3 times per day

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No