Ashwagandha for Cognitive Dysfunction

Last updated: June 13, 2023
Sponsor: Sutter Health
Overall Status: Active - Recruiting

Phase

2

Condition

Dementia

Mild Cognitive Impairment

Breast Cancer

Treatment

Ashwagandha

Placebo

Clinical Study ID

NCT04092647
SIMR_onc19_IIS_Behl_Ashwaga
  • Ages > 18
  • All Genders

Study 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 cancer.

Eligibility Criteria

Inclusion

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, orinformation processing or cognitive changes in the first 2 cycles of chemotherapy andscore < 63 on the FACT-Cog PCI
  5. Able to follow instructions for testing and comply with testing
  6. Able to swallow pills

Exclusion

Exclusion Criteria:

  1. Undergoing treatment for any hormone dependent cancer
  2. Planned surgical treatment
  3. History of pre-existing dementia, untreated depression, psychiatric disorder, priorbrain 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

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Ashwagandha
Phase: 2
Study Start date:
January 01, 2023
Estimated Completion Date:
July 01, 2025

Study 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-Cog PCI (Version 3). Patients that score less than 63, a score that reflects moderate to severe cognitive problems, are confirmed eligible. Subjects will be randomized 1:1 in blocks of 4.

Thyroid hormone testing will be conducted at baseline and at the end of week 6 for patients with a history of thyroid disease.

Patients will receive ashwagandha 350 mg po BID or placebo. The investigators and participants will be blinded to group assignment.

Endpoint testing including the FACT-Cog PCI and total score, Hopkins verbal learning test, trail making test (abstraction and executive function), and Mini Mental Status Exam (MMSE) will be administered at baseline and after 9 weeks of treatment. Six months after stopping the study, patients will receive a link to a REDCap database to complete the FACT-Cog and state whether they used ashwagandha once they completed the study.

Active study participation will be for 9 weeks.

Connect with a study center

  • Sutter Cancer Center

    Sacramento, California 95816
    United States

    Active - Recruiting

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