Status:
UNKNOWN
Ashwagandha for Cognitive Dysfunction
Lead Sponsor:
Sutter Health
Conditions:
Chemo Fog
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 can...
Detailed Description
Patients are eligible if they are currently undergoing chemotherapy or treatment with chemotherapy in the past year and state that they notice thinking or memory problems. Patients will be given FACT-...
Eligibility Criteria
Inclusion
- Age 18 years and older
- English speaking
- Currently undergoing chemotherapy or treatment with chemotherapy in the past year
- 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
- Able to follow instructions for testing and comply with testing
- Able to swallow pills
Exclusion
- Undergoing treatment for any hormone dependent cancer
- Planned surgical treatment
- History of pre-existing dementia, untreated depression, psychiatric disorder, prior brain radiation or brain injury
- History of hypotension
- Active autoimmune disease
- Brain metastasis
- Taking any drugs daily that would alter cognition
- Concurrent use of benzodiazepenes or other sedatives
- 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
- Currently taking hypoglycemic medications
- History of substance abuse
- Current or recent diagnosis of stomach ulcer or gastritis
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04092647
Start Date
January 1 2023
End Date
July 1 2025
Last Update
June 15 2023
Active Locations (1)
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1
Sutter Cancer Center
Sacramento, California, United States, 95816