Using ashwagandha to improve cognitive function in cancer patients undergoing chemotherapy
A Randomized Placebo-controlled Trial of Ashwagandha (Withania Somnifera) for Cognitive Dysfunction Associated With Cancer Chemotherapy.
This study is testing if ashwagandha can help cancer patients who are experiencing 'chemo fog' improve their thinking and memory while they are undergoing chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sutter Health Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04092647 on ClinicalTrials.gov |
What this trial studies
This interventional trial aims to evaluate the effectiveness of ashwagandha in improving cognitive dysfunction, often referred to as 'chemo fog', in patients currently undergoing chemotherapy or who have received it in the past year. Participants will be randomly assigned to receive either ashwagandha or a placebo in a double-blinded manner. Cognitive assessments will be conducted at baseline and after 9 weeks of treatment using various standardized tests. The study will also monitor thyroid hormone levels in patients with a history of thyroid disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are currently undergoing chemotherapy or have received it in the past year and report cognitive difficulties.
Not a fit: Patients with hormone-dependent cancers, pre-existing dementia, or those taking medications that alter cognition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural treatment option to alleviate cognitive dysfunction in cancer patients undergoing chemotherapy.
How similar studies have performed: While the use of ashwagandha for cognitive dysfunction is a novel approach, other studies have explored herbal supplements for cognitive enhancement, but specific results for ashwagandha in this context are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sacramento, California
- Sutter Cancer Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Deepti Behl, MD — Sutter Health
- Study coordinator: Michele Guillen
- Email: guillem1@sutterhealth.org
- Phone: 9168874656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.