Study on AHCC Supplement in Ovarian Cancer Patients Receiving Chemotherapy
Sponsor: University of California, Davis
ClinicalTrials ID:NCT05763199
This clinical trial is exploring the use of a supplement called AHCC in women with ovarian cancer who are undergoing chemotherapy. The study aims to see if AHCC can be safely used alongside standard cancer treatments.
Patient Parameters
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Program Overview
This study is testing a supplement called AHCC in women with ovarian cancer who are receiving chemotherapy. 20 participants will be randomly assigned to take either AHCC or a placebo while undergoing their usual cancer treatment. The study will take place at UC Davis Health Comprehensive Cancer Center. Researchers will monitor participants' quality of life and any side effects during the treatment. The goal is to determine if using AHCC in this way is feasible and safe.
Description
This study involves 20 women with ovarian cancer who are planning to undergo chemotherapy. Participants will be randomly divided into two groups: one group will receive AHCC (3 grams taken by mouth daily) and the other will receive a placebo. This will occur during their standard chemotherapy treatment. The study will assess participants' quality of life and any side effects at the start and during chemotherapy. The aim is to see if using AHCC alongside chemotherapy is practical and safe.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with certain types of ovarian, fallopian tube, or peritoneal cancer.
- Cancer can be at any stage from I to IV.
- Plan to receive standard chemotherapy after surgery, which includes specific drugs like platinum and taxane.
- Aged 18 or older.
- Able to speak English or Spanish.
- In good general health, able to perform daily activities with some limitations.
- Have adequate blood and organ function based on specific medical tests.
- Women who can become pregnant must agree to use effective birth control during the study and for 5 months after.
- Able to understand and willing to sign a consent form.
- HIV-positive patients can participate if they are on stable treatment and have a good immune status.
Exclusion Criteria
- Allergic to mushrooms, dextrin, rapeseed oil, or corn.
- Taking other mushroom-based supplements (eating whole mushrooms is okay).
- Using immunosuppressive medications recently, with some exceptions for low-dose or specific types of steroids.
- Have uncontrolled health issues like infections, heart problems, or mental health conditions that could affect safety or study participation.
- Unable to swallow pills or have had certain stomach surgeries.
- Pregnant or breastfeeding.
- Any condition that prevents understanding or agreeing to the study requirements.
- Any medical condition that could interfere with safety or compliance during the study.
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