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

Primary Purpose

Breast Cancer, Lung Cancer, Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
Sponsored by
Optimal Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Cancer Breast Lung Prostate

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

  • Optimal Health Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Other

Placebo Comparator

Active Comparator

Other

Placebo Comparator

Active Comparator

Other

Placebo Comparator

Active Comparator

Arm Label

Chemotherapeutic agent A (Docetaxel)

Chemotherapeutic agent A (Docetaxel) plus placebo

Chemotherapeutic agent A (Docetaxel) plus RaproCell

Chemotherapeutic agent B (Cisplatin)

Chemotherapeutic agent B (Cisplatin) plus placebo

Chemotherapeutic agent B (Cisplatin) plus RaproCell

Chemotherapeutic agent C (Docetaxel)

Chemotherapeutic agent C (Docetaxel) plus placebo

Chemotherapeutic agent C plus (Docetaxel) RaproCell

Arm Description

The patients with breast cancer will receive chemotherapeutic agent A

The patients with breast cancer will receive chemotherapeutic agent A plus a placebo.

The patients with breast cancer will receive chemotherapeutic agent A plus RaproCell.

The patients with lung cancer will receive Chemotherapeutic agent B

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

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

The patients with prostate cancer will receive Chemotherapeutic agent C

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 11, 2021
Last Updated
August 16, 2023
Sponsor
Optimal Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT05137067
Brief Title
A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optimal Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer, Prostate Cancer
Keywords
Cancer Breast Lung Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized interventional parallel study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Active product and placebo will be in identical packets.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapeutic agent A (Docetaxel)
Arm Type
Other
Arm Description
The patients with breast cancer will receive chemotherapeutic agent A
Arm Title
Chemotherapeutic agent A (Docetaxel) plus placebo
Arm Type
Placebo Comparator
Arm Description
The patients with breast cancer will receive chemotherapeutic agent A plus a placebo.
Arm Title
Chemotherapeutic agent A (Docetaxel) plus RaproCell
Arm Type
Active Comparator
Arm Description
The patients with breast cancer will receive chemotherapeutic agent A plus RaproCell.
Arm Title
Chemotherapeutic agent B (Cisplatin)
Arm Type
Other
Arm Description
The patients with lung cancer will receive Chemotherapeutic agent B
Arm Title
Chemotherapeutic agent B (Cisplatin) plus placebo
Arm Type
Placebo Comparator
Arm Description
The patients with lung cancer will receive Chemotherapeutic agent B plus placebo.
Arm Title
Chemotherapeutic agent B (Cisplatin) plus RaproCell
Arm Type
Active Comparator
Arm Description
The patients with lung cancer will receive Chemotherapeutic agent B plus RaproCell.
Arm Title
Chemotherapeutic agent C (Docetaxel)
Arm Type
Other
Arm Description
The patients with prostate cancer will receive Chemotherapeutic agent C
Arm Title
Chemotherapeutic agent C (Docetaxel) plus placebo
Arm Type
Placebo Comparator
Arm Description
The patients with prostate cancer will receive Chemotherapeutic agent C plus placebo.
Arm Title
Chemotherapeutic agent C plus (Docetaxel) RaproCell
Arm Type
Active Comparator
Arm Description
The patients with prostate cancer will receive Chemotherapeutic agent C plus RaproCell.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)
Other Intervention Name(s)
RaproCell
Intervention Description
Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.
Intervention Type
Drug
Intervention Name(s)
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
Intervention Description
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
Primary Outcome Measure Information:
Title
PROMIS (Patient-Reported Outcomes Measurement Information System) Global 10 Health Questionnaire to assess change from baseline.
Description
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.
Time Frame
Once a week for 3 months
Title
Symptom Assessment Questionnaire to assess change from baseline.
Description
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.
Time Frame
Once a week for 3 months
Secondary Outcome Measure Information:
Title
Cancer antigens blood markers to assess change from baseline.
Description
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.
Time Frame
Once a week for 3 months.

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Breast cancer: Female only Lung cancer: Both Female and Male Prostate cancer: Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EA Jeppsen, MD
Organizational Affiliation
Optimal Health Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Steven Osguthorpe, ND
Organizational Affiliation
Optimal Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optimal Health Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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