Ashwagandha for Cognitive Dysfunction

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 1:1 randomized double blinded placebo controlled trial. The primary objective is to determine if ashwagandha can improve cognitive dysfunction when compared with placebo in patients undergoing chemotherapy for breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sutter Health

Criteria

Inclusion Criteria:

1. Age 18 years and older

2. English speaking

3. No prior history of chemotherapy

4. Diagnosed with any stage of breast cancer and scheduled to undergo at least 4 cycles of chemotherapy

5. 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

6. Able to follow instructions for testing and comply with testing

7. Able to swallow pills

Exclusion Criteria:

1. History of pre-existing dementia, untreated depression, psychiatric disorder, prior brain radiation or brain injury

2. Brain metastasis

3. Taking any drugs daily that would alter cognition;

4. Currently taking hypoglycemic medications

5. History of substance abuse

6. No current or recent diagnosis of stomach ulcer or gastritis