Ashwagandha for Cognitive Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Placebo-controlled Trial of Ashwagandha (Withania Somnifera) for Cognitive Dysfunction Associated With Cancer Chemotherapy.

Conditions
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Chemo Fog

Intervention / Treatment
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* Drug: Ashwagandha
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older English speaking Currently undergoing chemotherapy or treatment with chemotherapy in the past year 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 Able to follow instructions for testing and comply with testing Able to swallow pills Exclusion Criteria: Undergoing treatment for any hormone dependent cancer Planned surgical treatment History of pre-existing dementia, untreated depression, psychiatric disorder, prior brain radiation or brain injury History of hypotension Active autoimmune disease Brain metastasis Taking any drugs daily that would alter cognition Concurrent use of benzodiazepenes or other sedatives 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 Currently taking hypoglycemic medications History of substance abuse Current or recent diagnosis of stomach ulcer or gastritis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a 1:1 randomized double blinded placebo controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ashwagandha<br>Ashwagandha | Drug: Ashwagandha<br>* Ashwagandha 350 mg po BID<br>|
| Placebo Comparator: placebo<br>Placebo | Drug: Placebo<br>* Placebo 350 mg po BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACT-Cog PCI | 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. | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ashwagandha, cognitive dysfunction, cancer chemotherapy