Breast CancerPhase 2NCT05137067
A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.
A Phase 2 study testing Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell) and Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel). in people with Breast Cancer and Lung Cancer, run by Optimal Health Research at 1 site in United States.
Trial summary
This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Breast Cancer, Lung Cancer, Prostate Cancer
- What is being tested?
- Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell) and Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 25 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- Anyone without the three types of cancer (breast cancer, lung cancer, prostate cancer) listed in inclusion criteria.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients.
Read the 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.
- Conditions
- Breast Cancer, Lung Cancer, Prostate Cancer
- Being tested
- 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).
- Keywords
- Cancer Breast Lung Prostate
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)Dietary supplement
Also called RaproCell
Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placeboDrug
Placebo
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).Drug
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapeutic agent A (Docetaxel) | Other | The patients with breast cancer will receive chemotherapeutic agent A Receives: 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. Receives: 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. Receives: 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 Receives: 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. Receives: 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. Receives: 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 Receives: 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. Receives: 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. Receives: Dietary Supplement: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Once a week for 3 months
Secondary outcomes (1)
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.
Measured: Once a week for 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start20 Jan 2021
- Primary completion18 Oct 2022
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized interventional parallel study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimal Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EA Jeppsen, MD, Study chair, Optimal Health ClinicSteven Osguthorpe, ND, Principal investigator, Optimal Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137067
- Sponsor's protocol ID
- RPC006
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05137067
- Acronym / sponsor ID
- RPC006
- Conditions
- Breast Cancer, Lung Cancer, Prostate Cancer
- Keywords
- Cancer Breast Lung Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Optimal Health ResearchUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- Randomized interventional parallel study
| Arm | Type | Receives |
|---|---|---|
| Chemotherapeutic agent A (Docetaxel) | Other | Drug: 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 | Placebo comparator | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placeboThe patients with breast cancer will receive chemotherapeutic agent A plus a placebo. |
| Chemotherapeutic agent A (Docetaxel) plus RaproCell | Active comparator | Dietary Supplement: 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) | Other | Drug: 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 | Placebo comparator | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placeboThe patients with lung cancer will receive Chemotherapeutic agent B plus placebo. |
| Chemotherapeutic agent B (Cisplatin) plus RaproCell | Active comparator | Dietary Supplement: 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) | Other | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).The patients with prostate cancer will receive Chemotherapeutic agent C |
| Chemotherapeutic agent C (Docetaxel) plus placebo | Placebo comparator | Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placeboThe patients with prostate cancer will receive Chemotherapeutic agent C plus placebo. |
| Chemotherapeutic agent C plus (Docetaxel) RaproCell | Active comparator | Dietary Supplement: 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- Anyone without the three types of cancer (breast cancer, lung cancer, prostate cancer) listed in inclusion criteria.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)Also: RaproCellChemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug. | Dietary supplement | Chemotherapeutic agent A (Docetaxel) plus RaproCell, Chemotherapeutic agent B (Cisplatin) plus RaproCell, Chemotherapeutic agent C plus (Docetaxel) RaproCell |
| Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placeboPlacebo | Drug | Chemotherapeutic agent A (Docetaxel) plus placebo, Chemotherapeutic agent B (Cisplatin) plus placebo, Chemotherapeutic agent C (Docetaxel) plus placebo |
| Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel). | Drug | Chemotherapeutic agent A (Docetaxel), Chemotherapeutic agent B (Cisplatin), Chemotherapeutic agent C (Docetaxel) |
Primary outcome
PROMIS (Patient-Reported Outcomes Measurement Information System) Global 10 Health Questionnaire to assess change from baseline.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Cancer antigens blood markers to assess change from baseline.
Time frame: Once a week for 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EA Jeppsen, MD study chair
Optimal Health Clinic
Steven Osguthorpe, ND principal investigator
Optimal Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell) and Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel). in people with Breast Cancer and Lung Cancer, run by Optimal Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS (Patient-Reported Outcomes Measurement Information System) Global 10 Health Questionnaire to assess change from baseline. (time frame: Once a week for 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.