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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lung Cancer; Prostate Cancer
• Intervention / Treatment: Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).; Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo; Dietary supplement: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Optimal Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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Exclusion Criteria:

Anyone without the three types of cancer (breast cancer, lung cancer, prostate cancer) listed in inclusion criteria.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Optimal Health Research
• Investigators: Study Chair: EA Jeppsen, MD, Optimal Health Clinic; Principal Investigator: Steven Osguthorpe, ND, Optimal Health Research

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): October 18, 2022
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Cancer Breast Lung Prostate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin; Antineoplastic Agents
• Other Study ID Numbers: RPC006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No