RECRUITING

Ashwagandha for Cognitive Dysfunction

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Conditions

Chemo Fogashwagandhacognitive dysfunctioncancer chemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-01
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04092647

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 years and older
  2. 2. English speaking
  3. 3. Currently undergoing chemotherapy or treatment with chemotherapy in the past year
  4. 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. 5. Able to follow instructions for testing and comply with testing
  6. 6. Able to swallow pills
  1. 1. Undergoing treatment for any hormone dependent cancer
  2. 2. Planned surgical treatment
  3. 3. History of pre-existing dementia, untreated depression, psychiatric disorder, prior brain radiation or brain injury
  4. 4. History of hypotension
  5. 5. Active autoimmune disease
  6. 6. Brain metastasis
  7. 7. Taking any drugs daily that would alter cognition
  8. 8. Concurrent use of benzodiazepenes or other sedatives
  9. 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. 10. Currently taking hypoglycemic medications
  11. 11. History of substance abuse
  12. 12. Current or recent diagnosis of stomach ulcer or gastritis

Contacts and Locations

Study Contact

Michele Guillen
CONTACT
9168874656
guillem1@sutterhealth.org
Carol Parise, PhD
CONTACT
9168874744
parisec@sutterhealth.org

Principal Investigator

Deepti Behl, MD
PRINCIPAL_INVESTIGATOR
Sutter Health
Carol Parise, PhD
STUDY_DIRECTOR
Sutter Health

Study Locations (Sites)

Sutter Cancer Center
Sacramento, California, 95816
United States

Collaborators and Investigators

Sponsor: Sutter Health

  • Deepti Behl, MD, PRINCIPAL_INVESTIGATOR, Sutter Health
  • Carol Parise, PhD, STUDY_DIRECTOR, Sutter Health

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 Registration Dates

Study Start Date2023-01-01
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • ashwagandha
  • cognitive dysfunction
  • cancer chemotherapy

Additional Relevant MeSH Terms

  • Chemo Fog