Recruiting
Phase 2

Ashwagandha

Sponsor:

Sutter Health

Code:

NCT04092647

Conditions

Chemo Fog

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ashwagandha

Placebo

Study Details

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 cancer.

Conditions

Chemo Fog

Study ID

NCT04092647

Start date

Jan 1, 2023

Status verified date

Jun, 2023

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ashwagandha

Ashwagandha

placebo comparator: placebo

Placebo

Interventions

Ashwagandha

Ashwagandha 350 mg po BID

Placebo

Placebo 350 mg po BID

Primary outcome measure

  • FACT-Cog PCI [ Time Frame: 9 weeks ]

Central Contacts and Locations

Central contacts

Locations

Sutter Cancer Center

Recruiting

Sacramento, California, United States, 95816

Contacts

Principal Investigator:

Deepti Behl, MD

More Information

Sponsor

Sutter Health

Last update posted

Jun 15, 2023

Last verified

Jun, 2023

Keywords

  • ashwagandha
  • cognitive dysfunction
  • cancer chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sutter Health on 2023-06-15.