Ashwagandha for Cognitive Dysfunction

Launched by SUTTER HEALTH · Sep 13, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether a natural supplement called ashwagandha can help improve memory and thinking problems, often referred to as "chemo fog," in patients who are undergoing chemotherapy for cancer. The researchers want to see if ashwagandha can make a difference compared to a placebo, which is a pill that looks like the real treatment but has no active ingredients.

To participate in this trial, you must be at least 18 years old, currently receiving chemotherapy or have received it in the past year, and have noticed some memory or thinking difficulties during your treatment. If you qualify and choose to join, you'll be randomly assigned to receive either ashwagandha or the placebo, and neither you nor the researchers will know which one you are getting (this is called a double-blind study). Participants will be expected to follow instructions for tests and take pills as directed. It’s important to note that certain health conditions or medications may prevent someone from joining, so talking to a doctor is essential. This trial is currently looking for participants, and your involvement could help contribute to understanding new ways to support cognitive health during cancer treatment.

Gender

ALL

Eligibility criteria

• 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