Clinical trial NCT04092647: Ashwagandha for Cognitive Dysfunction
Official title: A Randomized Placebo-controlled Trial of Ashwagandha (Withania Somnifera) for Cognitive Dysfunction Associated With Cancer Chemotherapy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chemo Fog
Keywords: ashwagandha
cognitive dysfunction
cancer chemotherapy
Lead sponsor: Sutter Health
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a 1:1 randomized double blinded placebo controlled trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: FACT-Cog PCI
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
Study officials:
affiliation: Sutter Health
name: Deepti Behl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sutter Health
name: Carol Parise, PhD
role: STUDY_DIRECTOR
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