Ashwagandha for Cognitive Dysfunction

Phase 2

Recruiting

• Conditions: Chemo Fog
• Interventions: Drug: Placebo; Drug: Ashwagandha

• Registration Number: NCT04092647
• Lead Sponsor: Sutter Health

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.

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-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.

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-17
• Study Start: 2023-01-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Placebo
ashwagandha	Ashwagandha	Ashwagandha

Primary Outcome Measures

Name	Time	Method
FACT-Cog PCI	9 weeks	The Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) is a 37-item questionnaire designed to assess cognitive complaints in patients with cancer. The Perceived Cognitive Impairment (PCI) subscale consists of 20 items designed to measure perceived impairment in quality of life. Scores range from 0-72 where higher scores indicate less impairment and better quality of life.

Trial Locations

Locations (1)

Sutter Cancer Center; 🇺🇸 Sacramento, California, United States