Chemo Fog
Conditions
Keywords
ashwagandha, cognitive dysfunction, cancer chemotherapy
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.
Interventions
DRUGAshwagandha
Ashwagandha 350 mg po BID
DRUGPlacebo
Placebo 350 mg po BID
Sponsors
Sutter Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a 1:1 randomized double blinded placebo controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactMichele Guillen
Backup ContactCarol Parise, PhD
Outcome results
None listed