A Randomized Placebo-controlled Trial of Ashwagandha (Withania Somnifera) for Cognitive Dysfunction Associated With Cancer Chemotherapy.

SIMR_onc19_IIS_Behl_Ashwaga

This is a 1:1 randomized double blinded placebo controlled trial. • To determine if ashwagandha can improve cognitive dysfunction when compared with placebo in patients undergoing chemotherapy for cancer.

2023-01-01

2024-12-31

2025-07-01

Recruiting

Early phase I

80

Inclusion Criteria: 1. Age 18 years and older 2. English speaking 3. Currently undergoing chemotherapy or treatment with chemotherapy in the past year 4. Self-reported memory loss, attention, visual-spatial functioning, reasoning, or information processing or cognitive changes in the first 2 cycles of chemotherapy and score \< 63 on the FACT-Cog PCI 5. Able to follow instructions for testing and comply with testing 6. Able to swallow pills Exclusion Criteria: 1. Undergoing treatment for any hormone dependent cancer 2. Planned surgical treatment 3. History of pre-existing dementia, untreated depression, psychiatric disorder, prior brain radiation or brain injury 4. History of hypotension 5. Active autoimmune disease 6. Brain metastasis 7. Taking any drugs daily that would alter cognition 8. Concurrent use of benzodiazepenes or other sedatives 9. Concurrent use of supplements that can cause sedation such as 5-HTP, calamus, California poppy, hops, Jamaican dogwood, kava, St.John's Wort, skullcap, valerian, yerba mansa 10. Currently taking hypoglycemic medications 11. History of substance abuse 12. Current or recent diagnosis of stomach ulcer or gastritis

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a 1:1 randomized double blinded placebo controlled trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2023-06-15