Breast Cancer, Lung Cancer, Prostate Cancer
Conditions
Keywords
Cancer Breast Lung Prostate
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.
Interventions
Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.
Placebo
Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
Sponsors
Study design
Masking description
Active product and placebo will be in identical packets.
Intervention model description
Randomized interventional parallel study
Eligibility
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States