Breast Cancer Clinical Trial

Ashwagandha for Cognitive Dysfunction

Summary

This is a 1:1 randomized double blinded placebo controlled trial. The primary objective is to determine if ashwagandha can improve cognitive dysfunction when compared with placebo in patients undergoing chemotherapy for breast cancer.

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Full Description

Patients are eligible if they are undergoing chemotherapy for breast cancer, are scheduled to receive at least four rounds, and state that they notice thinking or memory problems during their first two cycles of chemotherapy. 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.

Treatment will begin at the start of the third cycle of chemotherapy and continue for 9 weeks. 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 500 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age 18 years and older
English speaking
No prior history of chemotherapy
Diagnosed with any stage of breast cancer and scheduled to undergo at least 4 cycles of chemotherapy
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:

History of pre-existing dementia, untreated depression, psychiatric disorder, prior brain radiation or brain injury
Brain metastasis
Taking any drugs daily that would alter cognition;
Currently taking hypoglycemic medications
History of substance abuse
No current or recent diagnosis of stomach ulcer or gastritis

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT04092647

Recruitment Status:

Not yet recruiting

Sponsor:

Sutter Health

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There is 1 Location for this study

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Sutter Cancer Center
Sacramento California, 95816, United States More Info
Stacy D'Andre, MD
Contact
916-453-3300
[email protected]
Stacy D'Andre, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

80

Study ID:

NCT04092647

Recruitment Status:

Not yet recruiting

Sponsor:


Sutter Health

How clear is this clinincal trial information?

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