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

Sponsor
Optimal Health Research (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05137067
Collaborator
(none)
90
Enrollment
1
Location
9
Arms
23.2
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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) plus placebo
  • Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized interventional parallel studyRandomized interventional parallel study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Active product and placebo will be in identical packets.
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jan 20, 2021
Anticipated Primary Completion Date :
Oct 19, 2022
Anticipated Study Completion Date :
Dec 28, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Optimal Health Research Salt Lake City Utah United States 84117

    Sponsors and Collaborators

    • Optimal Health Research

    Investigators

    • Study Chair: EA Jeppsen, MD, Optimal Health Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Optimal Health Research
    ClinicalTrials.gov Identifier:
    NCT05137067
    Other Study ID Numbers:
    • RPC006
    First Posted:
    Nov 30, 2021
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Optimal Health Research
    Cancer Breast Lung Prostate
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Cisplatin
    Docetaxel
    Antineoplastic Agents

    Study Results

    No Results Posted as of Jul 20, 2022