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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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05137067
Enrollment
90
Registered
2021-11-30
Start date
2021-01-20
Completion date
2023-05-25
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lung Cancer, Prostate Cancer

Keywords

Cancer Breast Lung Prostate

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.

Interventions

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

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

DRUGChemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo

Placebo

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

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

Sponsors

Optimal Health Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Active product and placebo will be in identical packets.

Intervention model description

Randomized interventional parallel study

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
PROMIS (Patient-Reported Outcomes Measurement Information System) Global 10 Health Questionnaire to assess change from baseline.Once a week for 3 monthsA 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 monthsA 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

MeasureTime frameDescription
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026