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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Page 1 of 1 (1 locations)

1

Sutter Cancer Center

Sacramento, California, United States, 95816