NCT05137067

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

April 11, 2021

Last Update Submit

March 18, 2025

Conditions

Breast CancerLung CancerProstate Cancer

Keywords

Cancer Breast Lung Prostate

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Cancer antigens blood markers to assess change from baseline.

    Once a week for 3 months.

Study Arms (9)

Chemotherapeutic agent A (Docetaxel)

OTHER

The patients with breast cancer will receive chemotherapeutic agent A

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

Chemotherapeutic agent A (Docetaxel) plus placebo

PLACEBO COMPARATOR

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

Chemotherapeutic agent A (Docetaxel) plus RaproCell

ACTIVE COMPARATOR

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 agent B (Cisplatin)

OTHER

The patients with lung cancer will receive Chemotherapeutic agent B

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

Chemotherapeutic agent B (Cisplatin) plus placebo

PLACEBO COMPARATOR

The patients with lung cancer will receive Chemotherapeutic agent B plus placebo.

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

Chemotherapeutic agent B (Cisplatin) plus RaproCell

ACTIVE COMPARATOR

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 agent C (Docetaxel)

OTHER

The patients with prostate cancer will receive Chemotherapeutic agent C

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

Chemotherapeutic agent C (Docetaxel) plus placebo

PLACEBO COMPARATOR

The patients with prostate cancer will receive Chemotherapeutic agent C plus placebo.

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

Chemotherapeutic agent C plus (Docetaxel) RaproCell

ACTIVE COMPARATOR

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)

Interventions

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

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

Also known as: RaproCell
Chemotherapeutic agent A (Docetaxel) plus RaproCellChemotherapeutic agent B (Cisplatin) plus RaproCellChemotherapeutic agent C plus (Docetaxel) RaproCell
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placeboDRUG

Placebo

Chemotherapeutic agent A (Docetaxel) plus placeboChemotherapeutic agent B (Cisplatin) plus placeboChemotherapeutic agent C (Docetaxel) plus placebo
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).DRUG

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

Chemotherapeutic agent A (Docetaxel)Chemotherapeutic agent B (Cisplatin)Chemotherapeutic agent C (Docetaxel)

Eligibility Criteria

Age25 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBreast cancer: Female only Lung cancer: Both Female and Male Prostate cancer: Male
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optimal Health Research

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsProstatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • EA Jeppsen, MD

    Optimal Health Clinic

    STUDY CHAIR

  • Steven Osguthorpe, ND

    Optimal Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Active product and placebo will be in identical packets.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized interventional parallel study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2021

First Posted

November 30, 2021

Study Start

January 20, 2021

Primary Completion

October 18, 2022

Study Completion

May 25, 2023

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)