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Herbal Supplement
Ashwagandha for Cognitive Impairment
Phase 2
Recruiting
Led By Deepti Behl, MD
Research Sponsored by Sutter Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to swallow pills
Currently undergoing chemotherapy or treatment with chemotherapy in the past year
Must not have
Undergoing treatment for any hormone dependent cancer
History of hypotension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks
Summary
This trial is testing whether the herb ashwagandha can help improve cognitive function in breast cancer patients undergoing chemotherapy, compared to those taking a placebo.
Who is the study for?
This trial is for English-speaking adults over 18 who are currently undergoing chemotherapy or have had it within the past year, experiencing cognitive issues like memory loss. They must be able to swallow pills and follow test instructions. People with hormone-dependent cancers, brain conditions, hypotension, autoimmune diseases, substance abuse history, stomach ulcers or gastritis aren't eligible.
What is being tested?
The study tests if Ashwagandha can help with 'chemobrain'—cognitive problems after chemotherapy—compared to a placebo (a pill without active ingredients). Participants are randomly assigned to either the Ashwagandha group or placebo group in equal numbers without knowing which one they're getting.
What are the potential side effects?
Ashwagandha may cause sedation and might interact with other medications causing drowsiness. It could also lower blood pressure and affect blood sugar levels. Stomach irritation is possible too.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
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I am currently on chemotherapy or had it within the last year.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently being treated for a cancer that grows in response to hormones.
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I have a history of low blood pressure.
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I have a history of dementia, untreated depression, psychiatric disorder, or brain injury.
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I am not taking supplements that can make me sleepy.
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I am not on daily medication that affects my thinking.
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My cancer has spread to my brain.
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I have been diagnosed with a stomach ulcer or gastritis recently.
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I am currently taking medication to lower my blood sugar.
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I am currently taking sedatives or benzodiazepines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
FACT-Cog PCI
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ashwagandhaExperimental Treatment1 Intervention
Ashwagandha
Group II: placeboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ashwagandha
2024
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
Sutter HealthLead Sponsor
22 Previous Clinical Trials
63,709 Total Patients Enrolled
Deepti Behl, MDPrincipal InvestigatorSutter Health
Stacy D'Andre, MDPrincipal InvestigatorSutter Health
1 Previous Clinical Trials
39 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for a cancer that grows in response to hormones.I can swallow pills.You have experienced memory loss, trouble paying attention, or changes in your ability to think clearly during the first two cycles of chemotherapy, and your score on a specific memory and thinking test is less than 63.I have a history of low blood pressure.I am currently on chemotherapy or had it within the last year.You have a history of using drugs or alcohol in a harmful way.I have a history of dementia, untreated depression, psychiatric disorder, or brain injury.I am scheduled for surgery.I am not taking supplements that can make me sleepy.I am not on daily medication that affects my thinking.You have an ongoing autoimmune disease.My cancer has spread to my brain.I am 18 years old or older.I have been diagnosed with a stomach ulcer or gastritis recently.I am currently taking medication to lower my blood sugar.I am currently taking sedatives or benzodiazepines.
Research Study Groups:
This trial has the following groups:- Group 1: ashwagandha
- Group 2: placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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