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Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer (MIND-BC)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIND Diet Intervention Group
General Health Curriculum (GHC) Group
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Stage II-IV hormone receptor+, breast cancer diagnosis Post-menopausal (defined as at least 1-year post menses, on ovarian suppression medication, or s/p oophorectomy) Within +/- 4 weeks of starting initial systemic therapies (e.g. chemotherapy, targeted therapies, endocrine therapy) English speaking Exclusion Criteria: History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment MIND diet score >8 Unwilling/unable to eat >2 types of MIND food Receiving insulin therapy for diabetes Diagnosis of triple negative breast cancer Unable to give informed consent.

Sites / Locations

  • The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MIND-BC Intervention Group

General Health Curriculum (GHC) Control

Arm Description

Individual, tailored, behaviorally based nutrition counseling provided by a Registered Dietitian Nutritionist (RDN) and dietetic interns.

Sessions of non-diet related health topic education.

Outcomes

Primary Outcome Measures

Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT)
Assess cognition remotely through a Zoom session by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning. The HVLT is broken down into three trials of free-recall from a 12-item list of words, followed by a period of time then a fourth recall trial. Finally, the test ends with a recognition task. For all trials, the maximum score is 12 with higher scores indicating better cognition.
Remote assessment of cognition using the WAIS-IV Digit Span
Assess cognition remotely through a Zoom session by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory. The WAIS-IV Digit Span is comprised of three individual tests: Digit Span Forward, Digit Span Backward, and Digit Span Sequence. A total potential score of 48 with higher scores indicating better cognition.
Remote assessment of cognition using the Oral Trail Making Test
Assess cognition remotely through a Zoom session by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention. The OTMT is divided into part A and part B. The part A asks participants to count from 1-25, while part B asks participants to alternate between letters and numbers. The less amount of time required to complete the task equates to better cognition.
Remote assessment of cognition using the COWA Test
Assess cognition remotely through a Zoom session by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function. The COWAT has two components, the first asks the participants to say as many words as possible that begin with a given letter (F, A, or S) within the one-minute time frame. The second trial asks the same task but instead of letters, the participant is asked to produce as many animals as possible within the provided time frame. More words produced are indicative of better cognitive function.

Secondary Outcome Measures

Assessment of presence of CRCI symptoms (Neuro-Qol)
Assess the presence of cancer-related cognitive impairment (CRCI) symptoms using the Neuro-QoL Cognitive Function Test, a self-report measurement of cognitive function. Higher scores indicate better cognitive functioning with a range from 8 - 40 for the raw score and a T-score range from 17.3 - 64.2.
Assessment of presence of CRCI symptoms (FACT-Cog)
Assess presence of cancer-related cognitive impairment (CRCI) symptoms using the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog), a self-report measurement of cognitive function. Higher scores indicate better cognition with a range from 0 - 80.
Assessment of Diet Quality Measures
Assess diet quality measures from an electronic food frequency questionnaire.

Full Information

First Posted
May 17, 2023
Last Updated
August 2, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05984888
Brief Title
Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer
Acronym
MIND-BC
Official Title
Protecting the Brain From Toxic Side Effects of Chemotherapy: a Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Breast cancer (BC) is the most frequently diagnosed cancer in women. Systemic cancer treatments are an important contributor to dramatic improvements in the long-term survival of women with BC. However, cancer treatment can lead to cognitive impairment and declines in quality of life in women with BC. Many cancer survivors experience memory and brain function decline following chemotherapy which can last for years. A newer diet pattern, Mediterranean-DASH [Dietary Approaches to Stop Hypertension] Intervention for Neurodegenerative Delay (MIND), was shown to help with protecting brain functions. The MIND diet is high in anti-inflammatory nutrients (e.g., omega-3 polyunsaturated fatty acids (PUFAs), carotenoids, B-vitamins, and polyphenols) and limits the intake of brain-unhealthy foods (i.e., butter/margarine, cheese, red meat, fried foods, pastries, and sweets), which may help alleviate negative cognitive outcomes from cancer treatments. This randomized controlled trial aims to investigate the effect of the MIND diet on cognitive functions in women with invasive BC starting systemic therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIND-BC Intervention Group
Arm Type
Experimental
Arm Description
Individual, tailored, behaviorally based nutrition counseling provided by a Registered Dietitian Nutritionist (RDN) and dietetic interns.
Arm Title
General Health Curriculum (GHC) Control
Arm Type
Active Comparator
Arm Description
Sessions of non-diet related health topic education.
Intervention Type
Behavioral
Intervention Name(s)
MIND Diet Intervention Group
Intervention Description
Participants will receive individually tailored nutrition counseling on adopting the MIND diet pattern from a registered dietitian nutritionist (RDN) for a total of 8 sessions spanning 12 weeks. After completing the counseling sessions participants will be followed up 6 months later to collect additional questionnaires and assessments.
Intervention Type
Behavioral
Intervention Name(s)
General Health Curriculum (GHC) Group
Intervention Description
Participants will meet with trained study staff for 8 sessions spanning 12 weeks covering content on non-diet related health topics. After these sessions, participants will be followed up 6 months later to collect additional questionnaires and assessments. Once 6-month follow-up has been completed, participants will be offered to receive the MIND diet intervention offered in the MIND Diet Intervention Group.
Primary Outcome Measure Information:
Title
Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT)
Description
Assess cognition remotely through a Zoom session by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning. The HVLT is broken down into three trials of free-recall from a 12-item list of words, followed by a period of time then a fourth recall trial. Finally, the test ends with a recognition task. For all trials, the maximum score is 12 with higher scores indicating better cognition.
Time Frame
One day
Title
Remote assessment of cognition using the WAIS-IV Digit Span
Description
Assess cognition remotely through a Zoom session by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory. The WAIS-IV Digit Span is comprised of three individual tests: Digit Span Forward, Digit Span Backward, and Digit Span Sequence. A total potential score of 48 with higher scores indicating better cognition.
Time Frame
One day
Title
Remote assessment of cognition using the Oral Trail Making Test
Description
Assess cognition remotely through a Zoom session by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention. The OTMT is divided into part A and part B. The part A asks participants to count from 1-25, while part B asks participants to alternate between letters and numbers. The less amount of time required to complete the task equates to better cognition.
Time Frame
One day
Title
Remote assessment of cognition using the COWA Test
Description
Assess cognition remotely through a Zoom session by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function. The COWAT has two components, the first asks the participants to say as many words as possible that begin with a given letter (F, A, or S) within the one-minute time frame. The second trial asks the same task but instead of letters, the participant is asked to produce as many animals as possible within the provided time frame. More words produced are indicative of better cognitive function.
Time Frame
One day
Secondary Outcome Measure Information:
Title
Assessment of presence of CRCI symptoms (Neuro-Qol)
Description
Assess the presence of cancer-related cognitive impairment (CRCI) symptoms using the Neuro-QoL Cognitive Function Test, a self-report measurement of cognitive function. Higher scores indicate better cognitive functioning with a range from 8 - 40 for the raw score and a T-score range from 17.3 - 64.2.
Time Frame
One day
Title
Assessment of presence of CRCI symptoms (FACT-Cog)
Description
Assess presence of cancer-related cognitive impairment (CRCI) symptoms using the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog), a self-report measurement of cognitive function. Higher scores indicate better cognition with a range from 0 - 80.
Time Frame
One day
Title
Assessment of Diet Quality Measures
Description
Assess diet quality measures from an electronic food frequency questionnaire.
Time Frame
One day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage II-IV hormone receptor+, breast cancer diagnosis Post-menopausal (defined as at least 1-year post menses, on ovarian suppression medication, or s/p oophorectomy) Within +/- 4 weeks of starting initial systemic therapies (e.g. chemotherapy, targeted therapies, endocrine therapy) English speaking Exclusion Criteria: History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment MIND diet score >8 Unwilling/unable to eat >2 types of MIND food Receiving insulin therapy for diabetes Diagnosis of triple negative breast cancer Unable to give informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tonya S Orchard, PhD
Phone
614-292-7241
Email
orchard.6@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kellie R Weinhold, MS
Email
weinhold.8@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonya S Orchard, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonya S Orchard, PhD
Phone
614-292-7241
Email
orchard.6@osu.edu
First Name & Middle Initial & Last Name & Degree
Kellie R Weinhold, MS
Email
weinhold.8@osu.edu
First Name & Middle Initial & Last Name & Degree
Tonya S Orchard, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer

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