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Chemotherapy-Related Cognitive Impairment

Cognition Disorders

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All Drugs and Chemicals

Ashwagandha

Placebo

Michele Guillen

Carol Parise, PhD

Deepti Behl, MD

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.

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.

This is a 1:1 randomized double blinded placebo controlled trial.

Ashwagandha for Cognitive Dysfunction

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

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.

Sutter Health

Principal Investigator

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.

Transdermal nicotine

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Placebo Transdermal Patch

Paul A Newhouse, M.D.

The purpose of this study is to evaluate the use of a nicotine patch as a treatment for problems with attention, learning and memory in breast cancer patients who are 1-5 years post chemotherapy.

Studies have suggested that chemotherapy treatment for breast cancer may change the way the brain functions. As a result, patients who receive chemotherapy for breast cancer may experience problems with their attention, learning, and memory that they did not have before receiving chemotherapy. The investigators have found that nicotine treatment can help other types of patients with similar difficulties with attention, learning, and memory. Nicotine is a naturally occurring substance found in tobacco and is known to interact with nerve cells in the brain that are important for functions like learning and memory, and has been studied in a number of disorders. This study is designed to test whether nicotine treatment is helpful for learning and memory problems after chemotherapy for breast cancer.

This study will be a randomized, placebo-controlled pilot study to evaluate the effect of transdermal nicotine to 1) reduce subjective complaints and 2) enhance cognitive performance on laboratory measures of cognitive performance in breast cancer patients with persistent chemotherapy-related cognitive impairment (CRCI), a condition also known as "chemo brain." Participants will be randomized to either placebo or active compound (50/50) for the 6-week treatment portion of the study. Participants will be assessed before, during, and at the end of treatment. At the end of the 8-week study, participants will have the option to take part in the open-label portion of the study for an additional 6 weeks.

Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study

The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale will be used to monitor change in CRCI subjective complaints.

This instrument has been used to monitor change in CRCI subjective complaints in previous studies and demonstrates good internal consistency, test-retest reliability, and discriminant and convergent validity. Specifically, the PCI subscale was used as the primary outcome measure.

The FACT-Cog PCI consists of 20 items and has a minimum score of 0 and total possible score of 72. Higher scores indicate better cognitive functioning.

The PCI evaluates memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability.

Visit 3 is the 3-week visit, Visit 4 is the 6-week visit, and Visit 5 is the 8-week visit.

Change scores were calculated as follow

The secondary outcome measure was the computerized Conners Continuous Performance Test (CPT), which measures sustained attention and vigilance. Participants see a series of letters appearing one at a time on a computer screen and they press a button for every letter that appears on the screen, except for "X". Lower scores indicate better performance.

Scores on the CPT are calculated using the each participant's performance on the task (defined as reaction time (in ms) standard error/interstimulus interval). Change scores from baseline are then calculated. A decrease in CPT score = improvement.

\*This is not a clinical measure. This is a research measure of reaction time variability and therefore there is no clinical interpretation and no defined score range.\*

Vanderbilt University Medical Center

Professor of Psychiatry, Pharmacology, and Medicine

Adverse events were recorded and categorized by body system, event type, attribution, frequency, severity, and course. AEs were assessed across all double-blind study visits and categorized according to body system for all participants who received at least one dose of patches (nicotine n = 12, placebo n = 13).

Nicotine will be delivered by a transdermal patch delivery system for topical application. Each patch will contain approximately 1.75mg nicotine/cm2, and releases 7, and 14mg of nicotine, respectively, over 24 hours. Patches will be applied for 16 hours per day. Participants will be titrated over the course of the 6-week treatment period in order to avoid initial side effects as follows:

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Transdermal nicotine: Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.

Transdermal Nicotine

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Placebo Transdermal Patch

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Cancer Type

Cancer Stage

Chemotherapy

Surgery

Radiation

Cancer Treatment Received

Current Endocrine Therapy

Post-Menopausal Status

Small sample size numbers; treatment duration of 6-weeks may not have been enough time to distinguish between a drug and placebo response; 14mg may not have been a sufficient dose to fully test this hypothesis.

Dr. Paul A. Newhouse

For the Primary Aim (Specific Aim 1), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline PCI FACT-Cog score (Visit 3, Visit 4, and Visit 5) as the dependent measure.

Visit 3 PCI Change from Baseline Score (3-Weeks)

Visit 4 PCI Change from Baseline Score (6-Weeks)

Visit 5 PCI Change from Baseline Score (8-Weeks)

Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale

For the Secondary Aim (Specific Aim 2), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline CPT Scores (Visit 3, Visit 4, and Visit 5) as the dependent measure.

Visit 3 CPT Change from Baseline Score (3-Weeks)

Visit 4 CPT Change from Baseline Score (6-Weeks)

Visit 5 CPT Change from Baseline Score (8-Weeks)

Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Week 1: ½ 7 mg patch per day, Week 2: 7 mg patch per day, Weeks 3-4: ¾ 14 mg patch per day, Weeks 5-6: 14 mg per day, Weeks 7-8: Treatment withdrawal

Placebo Transdermal Patch: Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.

Conners Continuous Performance Test

Overall Study

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Joseph McCollom, DO

Emily Powell, PHD

Dr Joseph McCollom, DO

The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.

All self representation of gender identity accepted

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

This panel of plasma factors will be will be used to detect protein from the blood of patients throughout and after chemotherapy treatment.

Indiana University School of Medicine

Joseph McCollom

Oncologist

Breast Diseases

Skin Diseases

Breast cancer patients treated with adjuvant chemotherapy of various types.

Breast cancer patients treated with adjuvant hormonal therapy but not chemotherapy.

Barbara Collins

Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study is investigating this phenomenon by measuring mental function of breast cancer patients prior to and after exposure to chemotherapy, and by comparing mental function in those patients who receive chemotherapy and those who do not.

Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study will investigate this phenomenon by measuring neuropsychological functioning in early stage breast cancer patients prior to and after exposure to chemotherapy, and by comparing change in cognitive function in patients who receive chemotherapy to similar breast cancer patients receiving hormonal therapy only.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ashwagandha for Cognitive Dysfunction	NCT04092647	Chemo Fog	Ashwagandha Placebo	18 Years -	Sutter Health
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study	NCT02312934	Chemo Brain Chemotherapy-re... Chemo Fog Breast Cancer Chemobrain	Transdermal nic... Placebo Transde...	35 Years - 80 Years	Vanderbilt University Medical Center
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy	NCT05014399	Neoplasm, Color... Cognitive Impai... Cognitive Dysfu... Cognitive Chang... Chemo-brain Chemo Fog Chemotherapy Ef... Cognitive Decli...		18 Years -	Parkview Health
Study of the Effects of Chemotherapy on Memory and Other Mental Functions in Women With Breast Cancer	NCT00260975	Breast Cancer		50 Years - 65 Years	Ottawa Hospital Research Institute
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study	NCT02312934	Chemo Brain Chemotherapy-re... Chemo Fog Breast Cancer Chemobrain	Transdermal nic... Placebo Transde...	35 Years - 80 Years	Vanderbilt University Medical Center
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy	NCT05014399	Neoplasm, Color... Cognitive Impai... Cognitive Dysfu... Cognitive Chang... Chemo-brain Chemo Fog Chemotherapy Ef... Cognitive Decli...		18 Years -	Parkview Health

Spots Global Cancer Trial Database for chemo fog

Every month we try and update this database with for chemo fog cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for chemo fog

Every month we try and update this database with for chemo fog cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for chemo fog cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.