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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137067
• Other study ID #: RPC006
• Status: Completed
• Phase: Phase 2
• Start date: January 20, 2021
• Est. completion date: May 25, 2023

Study information

• Verified date: August 2023
• Source: Optimal Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 25, 2023
• Est. primary completion date: October 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)
Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.

Drug:
• Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo
Placebo
• Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).

Locations

Country	Name	City	State
United States	Optimal Health Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Optimal Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.