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

Study Overview
=================
Brief Summary
-----------------
This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients.

Detailed Description
-----------------
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.

Official Title
-----------------
Effectiveness of RaproCell in Alleviating the Side Effects of Chemotherapeutic Agents, Without Adversely Impacting the Overall Success of the Agents on Cancer Cells.

Conditions
-----------------
Breast Cancer, Lung Cancer, Prostate Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)
* Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo
* Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).


Participation Criteria
=================
Eligibility Criteria
-----------------
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. -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized interventional parallel study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chemotherapeutic agent A (Docetaxel)<br>The patients with breast cancer will receive chemotherapeutic agent A | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).<br>* Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).<br>|
| Placebo Comparator: Chemotherapeutic agent A (Docetaxel) plus placebo<br>The patients with breast cancer will receive chemotherapeutic agent A plus a placebo. | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo<br>* Placebo<br>|
| Active Comparator: Chemotherapeutic agent A (Docetaxel) plus RaproCell<br>The patients with breast cancer will receive chemotherapeutic agent A plus RaproCell. | Dietary Supplement: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)<br>* Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.<br>* Other names: RaproCell;|
| Other: Chemotherapeutic agent B (Cisplatin)<br>The patients with lung cancer will receive Chemotherapeutic agent B | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).<br>* Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).<br>|
| Placebo Comparator: Chemotherapeutic agent B (Cisplatin) plus placebo<br>The patients with lung cancer will receive Chemotherapeutic agent B plus placebo. | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo<br>* Placebo<br>|
| Active Comparator: Chemotherapeutic agent B (Cisplatin) plus RaproCell<br>The patients with lung cancer will receive Chemotherapeutic agent B plus RaproCell. | Dietary Supplement: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)<br>* Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.<br>* Other names: RaproCell;|
| Other: Chemotherapeutic agent C (Docetaxel)<br>The patients with prostate cancer will receive Chemotherapeutic agent C | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).<br>* Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).<br>|
| Placebo Comparator: Chemotherapeutic agent C (Docetaxel) plus placebo<br>The patients with prostate cancer will receive Chemotherapeutic agent C plus placebo. | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo<br>* Placebo<br>|
| Active Comparator: Chemotherapeutic agent C plus (Docetaxel) RaproCell<br>The patients with prostate cancer will receive Chemotherapeutic agent C plus RaproCell. | Dietary Supplement: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)<br>* Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.<br>* Other names: RaproCell;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Once a week for 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Once a week for 3 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer Breast Lung Prostate