This is a pilot phase, randomized, double-blinded feasibility pilot study of AHCC in participants with ovarian cancer.
This is a pilot phase, randomized, double-blinded feasibility pilot study of AHCC in participants with ovarian cancer. 20 women who plan to undergo adjuvant chemotherapy for ovarian cancer at the University of California (UC) Davis Health Comprehensive Cancer Center will be enrolled and randomized 1:1 to receive AHCC (3 grams by mouth daily) or placebo during standard of care chemotherapy. HRQOL and adverse events will be assessed at baseline and during chemotherapy. The hypothesis is that a randomized controlled trial of AHCC supplementation for ovarian cancer patients on adjuvant chemotherapy is feasible.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
20
AHCC is the cultured mycelia of Lentinula edodes mushrooms from the Basidiomycetes family.
Chemotherapy will be administered per standard of care.
Dextrin
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Proportion of participants consent and randomized to taking AHCC or placebo during adjuvant chemotherapy compared to to total number of ovarian cancer patients eligible for the trial following prescreening and participation invitation.
Time frame: Study activation to randomization of 20th participant
Time required to randomize 20 participants
Time frame: Study activation to randomization of 20th participant.
Proportion of participants that complete study treatment
Time frame: First dose through Cycle 3-6 post adjuvant chemotherapy; each cycle is 3 weeks
Proportion of participants that adhere to taking study treatment
Time frame: First dose through Cycle 3-6 post adjuvant chemotherapy; each cycle is 3 weeks
Adherence to taking study treatment for each participant
Time frame: First dose through Cycle 3-6 post adjuvant chemotherapy; each cycle is 3 weeks
Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
All health-related quality of life assessments use a 5 point Likert-type scale and is scored based on a manual scoring template, some items are reverse scored; the higher the score, the better the quality of life.
Time frame: Baseline through 30d post last dose
Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - Neurotoxicity (FACT/ GOG-NTX)
All health-related quality of life assessments use a 5 point Likert-type scale and is scored based on a manual scoring template, some items are reverse scored; the higher the score, the better the quality of life.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline through 30d post last dose
Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
All health-related quality of life assessments use a 5 point Likert-type scale and is scored based on a manual scoring template, some items are reverse scored; the higher the score, the better the quality of life.
Time frame: Baseline through 30d post last dose
Participant experience self-reported in the acceptability questionnaire compared to self-reported anticipated acceptability
The acceptability questionnaire measures the following ordinal data listed in order of most acceptable to least acceptable: strongly agree, agree, neutral, disagree, and strongly disagree.
Time frame: Baseline and at end of treatment (about 9-18 weeks post adjuvant chemotherapy)