NCT04092647

Ashwagandha for Cognitive Dysfunction

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sutter Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemo Fog

Interventions

Type	Name	Description
DRUG	Ashwagandha	Ashwagandha 350 mg po BID
DRUG	Placebo	Placebo 350 mg po BID

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-31
• Completion: 2025-07-01
• First posted: 2019-09-17
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study