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

Phase 2

Completed

• Conditions: Breast Cancer; Lung Cancer; Prostate Cancer
• Interventions: 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).; Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo

• Registration Number: NCT05137067
• Lead Sponsor: Optimal Health Research

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.

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-11-30
• Primary Completion: 2022-10-18
• Study Completion: 2023-05-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapeutic agent A (Docetaxel) plus RaproCell	Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)	The patients with breast cancer will receive chemotherapeutic agent A plus RaproCell.
Chemotherapeutic agent B (Cisplatin)	Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).	The patients with lung cancer will receive Chemotherapeutic agent B
Chemotherapeutic agent B (Cisplatin) plus placebo	Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo	The patients with lung cancer will receive Chemotherapeutic agent B plus placebo.
Chemotherapeutic agent B (Cisplatin) plus RaproCell	Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)	The patients with lung cancer will receive Chemotherapeutic agent B plus RaproCell.
Chemotherapeutic agent C (Docetaxel)	Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).	The patients with prostate cancer will receive Chemotherapeutic agent C
Chemotherapeutic agent A (Docetaxel)	Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).	The patients with breast cancer will receive chemotherapeutic agent A
Chemotherapeutic agent A (Docetaxel) plus placebo	Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo	The patients with breast cancer will receive chemotherapeutic agent A plus a placebo.
Chemotherapeutic agent C (Docetaxel) plus placebo	Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo	The patients with prostate cancer will receive Chemotherapeutic agent C plus placebo.
Chemotherapeutic agent C plus (Docetaxel) RaproCell	Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)	The patients with prostate cancer will receive Chemotherapeutic agent C plus RaproCell.

Primary Outcome Measures

Name	Time	Method
PROMIS (Patient-Reported Outcomes Measurement Information System) Global 10 Health Questionnaire to assess change from baseline.	Once a week for 3 months	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.
Symptom Assessment Questionnaire to assess change from baseline.	Once a week for 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Cancer antigens blood markers to assess change from baseline.	Once a week for 3 months.	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.

Trial Locations

Locations (1)

Optimal Health Research; 🇺🇸 Salt Lake City, Utah, United States