A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.

Optimal Health Research90 enrolled

Overview

This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients.

This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients. The study will be observing the standard treatment protocol for any degradation or enhancement due to the nutraceutical.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Breast Cancer Lung Cancer Prostate Cancer

Interventions

Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)DIETARY_SUPPLEMENT

Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.

Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placeboDRUG

Placebo

Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).DRUG

Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Active breast cancer patients taking one of the studies listed drugs within the age range. Active lung cancer patients taking one of the studies listed drugs within the age range. Active prostate cancer patients taking one of the studies listed drugs within the age range. \- Exclusion Criteria: Anyone without the three types of cancer (breast cancer, lung cancer, prostate cancer) listed in inclusion criteria. \-

Locations (1)

Optimal Health Research

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

PROMIS (Patient-Reported Outcomes Measurement Information System) Global 10 Health Questionnaire to assess change from baseline.

A summary indicator of health status by assessing 5 domains: physical function, fatigue, pain, emotional distress, and social health to assess change from baseline for improvement or decline.

Time frame: Once a week for 3 months

Symptom Assessment Questionnaire to assess change from baseline.

A symptom is a sensation or perception of change related to health function experienced by an individual. Symptoms such as fatigue, pain and nausea can be classified according to their severity and perceived impact on function as a change from baseline for improvement or decline.

Time frame: Once a week for 3 months

Secondary Outcomes

Cancer antigens blood markers to assess change from baseline.

Breast: CA 27.29, serial monitor report; carcinoembryonic antigen (CEA), serial monitor report; lipid-associated sialic acid (LASA), serial monitor report. Lung: Carcinoembryonic antigen (CEA), serial monitor report; lipid-associated sialic acid (LASA), serial monitor report; neuron-specific enolase (NSE), serial monitor report. Prostate: Prostate-specific antigen (PSA), serial monitor report; prostatic acid phosphatase (PAP), serial monitor report as a change from baseline for improvement or decline.

Time frame: Once a week for 3 months.

Data from ClinicalTrials.gov

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