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This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapeutic agent A (Docetaxel) | Other | The patients with breast cancer will receive chemotherapeutic agent A |
|
| Chemotherapeutic agent A (Docetaxel) plus placebo | Placebo Comparator | The patients with breast cancer will receive chemotherapeutic agent A plus a placebo. |
|
| Chemotherapeutic agent A (Docetaxel) plus RaproCell | Active Comparator | The patients with breast cancer will receive chemotherapeutic agent A plus RaproCell. |
|
| Chemotherapeutic agent B (Cisplatin) | Other | The patients with lung cancer will receive Chemotherapeutic agent B |
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| Chemotherapeutic agent B (Cisplatin) plus placebo | Placebo Comparator | The patients with lung cancer will receive Chemotherapeutic agent B plus placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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Exclusion Criteria:
Anyone without the three types of cancer (breast cancer, lung cancer, prostate cancer) listed in inclusion criteria.
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Breast cancer: Female only
Lung cancer: Both Female and Male
Prostate cancer: Male
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| Name | Affiliation | Role |
|---|---|---|
| EA Jeppsen, MD | Optimal Health Clinic | Study Chair |
| Steven Osguthorpe, ND | Optimal Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optimal Health Research | Salt Lake City | Utah | 84117 | United States |
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Randomized interventional parallel study
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Active product and placebo will be in identical packets.
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| Chemotherapeutic agent B (Cisplatin) plus RaproCell | Active Comparator | The patients with lung cancer will receive Chemotherapeutic agent B plus RaproCell. |
|
| Chemotherapeutic agent C (Docetaxel) | Other | The patients with prostate cancer will receive Chemotherapeutic agent C |
|
| Chemotherapeutic agent C (Docetaxel) plus placebo | Placebo Comparator | The patients with prostate cancer will receive Chemotherapeutic agent C plus placebo. |
|
| Chemotherapeutic agent C plus (Docetaxel) RaproCell | Active Comparator | The patients with prostate cancer will receive Chemotherapeutic agent C plus RaproCell. |
|
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| Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo | Drug | Placebo |
|
| Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel). | Drug | Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel). |
|
| Once a week for 3 months. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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