Ashwagandha for Cognitive Dysfunction

June 13, 2023 updated by: Deepti Behl, Sutter Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Cancer Center
        • Principal Investigator:
          • Deepti Behl, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Placebo
Drug: Placebo
Placebo 350 mg po BID
Experimental: ashwagandha
Ashwagandha
Drug: Ashwagandha
Ashwagandha 350 mg po BID

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sutter Health

Investigators

  • Study Director: Carol Parise, PhD, Sutter Health
  • Principal Investigator: Deepti Behl, MD, Sutter Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (Actual)

September 17, 2019

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIMR_onc19_IIS_Behl_Ashwaga

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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