Skip to content

Gene Expression, Meditative Movement, and Emotional Distress (GME)

Gene Expression, Meditative Movement, and Emotional Distress (GME): A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04213872
Acronym
GME
Enrollment
27
Registered
2019-12-30
Start date
2017-07-17
Completion date
2020-09-15
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment

Keywords

breast cancer survivors, gene expression, emotional distress

Brief summary

Study Title: Gene Expression, Meditative Movement and Emotional Distress (GME) Background and Objectives: Breast cancer survivors (BCS) often report decrements in cognitive functioning. Cognitive impairment (CI) is generally understood as resulting from chemotherapy or radiation, but may also result from chronic emotional distress experienced by breast cancer patients and survivors. Meditation and exercise are both known to reduce stress, with growing evidence for the potential of each to also improve cognitive functioning in cancer patients and survivors. A Meditative Movement (MM) program (Qigong/Tai Chi Easy) offers the potential of combining both benefits of meditation and exercise for breast cancer survivors. This is a pilot study, testing the MM program to effect changes in cognitive functioning and associated symptoms/conditions such as anxiety, depression, sleep quality and using gene expression factors as biomarkers to potentially measure the molecular signature of these changes. Forty BCS will be consented and assigned to an intensive eight week MM program. Cognitive functioning and associated symptoms/conditions will be assessed before and after the 8-week MM program to examine the participants' behaviors and symptoms. Peripheral blood samples will be collected before and after the 8-week MM program and will be analyzed for gene expression changes. If successful, this study may provide preliminary data for a full powered randomized control trial if results show promise in the psycho-behavioral outcomes and genomic expression results.

Detailed description

This is a single-group pilot study on the effects of 8 weeks of MM practice on changes in cognitive function, anxiety, sleep quality, depression, and selected gene expression factors. Forty BCS will be consented and assigned to an intensive eight-week MM program. The forty BCS will be nonrandomly assigned to the eight-week MM program with no control group. The forty BCS will be organized in cohorts of 10 for the 8-week MM program. Cognitive functioning and associated symptoms/conditions data will be collected before and after the 8-week MM program to assess cognitive functioning, anxiety, depression, and sleep-quality. This data will be analyzed using the IBM SPSS Statistics program. Peripheral blood samples will be collected before and after the 8-week MM program. The gene expression data will be processed and analyzed by the bioinformatics team at the Single-Cell, Sequencing, and CyTOF Core (SC2), Children's Hospital Los Angeles (CHLA), Los Angeles. Endpoints: Endpoint 1: The Meditative Movement (MM) program will affect cognitive impairment. Endpoint 2: The Meditative Movement (MM) program will affect anxiety, depression, and sleep quality. Endpoint 3: The MM program will affect gene expression associated with cognitive impairment and associated symptoms.

Interventions

The Meditative Movement program is a blend of meditation and exercise based on Tai Chi and Qigong.

Sponsors

Children's Hospital Los Angeles
CollaboratorOTHER
Arizona State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

This is a single-group nonrandomized pilot study on the effects of 8 weeks of MM program on changes in cognitive function, anxiety, sleep quality, depression, and selected gene expression factors.

Eligibility

Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female patients diagnosed with breast cancer, Stage 0- III * Between 6 months and 5 years past primary treatment * 45 years of age and older * Post-menopausal * Speak or understand English

Exclusion criteria

* Women who are unable to stand (e.g., wheelchair or walker bound) * Patients who are too weak or ill * Women on antibiotics. * Working night shift * Anemia * Uncontrolled diabetes

Design outcomes

Primary

MeasureTime frameDescription
Profile of Mood States Short Form (POMS-SF) - DepressionMeasures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.The POMs-SF consists of 37 items, adjectives scored on a 5-point Likert scale. POMS consists of the Total Mood Disturbance (TMD) dimensions (tension-anxiety; depression-dejection; anger-hostility; confusion-bewilderment. This pilot study reported results for the depression-dejection TMD dimension (12 items). Lower scores mean better outcomes.
Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Digit Span Forward and BackwardMeasures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.WAIS-III): Digit Span Forward and Backward measures working memory using numbers in a series recall. The scoring range is 0 to 30 with higher scores meaning better outcomes.
Pittsburg Sleep Quality Index (PSQI)Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.The PSQI is a 19-item self-report questionnaire designed to assess sleep quality and disturbances over a I-month interval. The Pittsburgh Sleep Quality Index (PSQI): 19 items assess sleep, including subscales for subjective sleep quality, sleep latency, sleep duration, sleep disturbance, habitual sleep efficiency, daytime dysfunction and use of sleep medications. A global PSQI score \>5 distinguishes good from poor sleepers. Lower scores mean better outcomes.
Profile of Mood States Short Form (POMS-SF) - AnxietyMeasures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.The POMs-SF consists of 37 items, adjectives scored on a 5-point Likert scale. POMS consists of the Total Mood Disturbance (TMD) dimensions (tension-anxiety; depression-dejection; anger-hostility; confusion-bewilderment. This pilot study reported results for the tension-anxiety TMD dimensions (12 items). Lower scores mean better outcomes.
Perceived Cognitive Impairments (CogPCI)Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.Perceived Cognitive Impairments (CogPCI) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 20 items. The range of values are 0-80 with lower scores signifying better outcomes.
Perceived Cognitive Abilities (CogPCA)Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.Perceived Cognitive Abilities (CogPCA) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 9 items. The range of values are 0-36 with higher scores signifying better outcomes.
Impact on Quality of Life (CogQOL)Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.Impact on Quality of Life (CogQOL) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 4 items. The range of values are 0-16 with lower scores signifying better outcomes.
Comments From Others (CogOth)Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.Comments from Others (CogOth) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 4 items. The range of values are 0-16 with lower scores signifying better outcomes.
Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Letter-Number SequencingMeasures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.WAIS-III: Letter-Number Sequencing measures working memory using letters and numbers in sequence recall. The scoring range is 0 to 21 with higher scores meaning better outcomes.

Secondary

MeasureTime frameDescription
Nuclear Factor Kappa B (NF-kB1) Gene ExpressionMeasures data on gene expression were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.Decreased levels of NF-kB1 gene expression are associated with improvements in managing chronic stress. Blood samples were collected post-intervention for RNA Sequencing to measure RNA levels as indicators of gene expression. Lower scores indicate better outcomes.
Tumor Protein 53 (TP53) Gene ExpressionMeasures data on gene expression were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.Increased TP53 gene expression is associated with suppressing cancer growth. Blood samples were collected post-intervention for RNA Sequencing to measure RNA levels as indicators of gene expression. Higher scores mean better outcomes.
Brain Derived Neurotropic Factor (BDNF) Gene ExpressionMeasures data on gene expression were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.The BDNF gene regulates synaptic plasticity associated with cognitive functioning. Increased levels of BDNF gene expression are associated with improved cognitive functioning. Blood samples were collected post-intervention for RNA Sequencing to measure RNA levels as indicators of gene expression. Higher scores mean better outcomes.

Countries

United States

Participant flow

Participants by arm

ArmCount
Meditative Movement (MM)
The Meditative Movement (Qigong/Tai Chi Easy) program will be 8 weeks in duration with sessions once a week. Each session is approximately one hour. The PI will lead the MM sessions. The PI and the CRC will maintain contact with the MM group during the 8 weeks by telephone or in person. Meditative Movement: The Meditative Movement program is a blend of meditation and exercise based on Tai Chi and Qigong.
14
Total14

Baseline characteristics

CharacteristicMeditative Movement (MM)
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
Brain derived neurotrophic factor (BDNF)0.11 fold change
STANDARD_DEVIATION 0.9
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
FACT-COG: Comments from Others1.5 units on a scale
STANDARD_DEVIATION 2.1
(FACT-COG)-Perceived Cog Impairment25.4 units on a scale
STANDARD_DEVIATION 14.2
FACT-COG: Perceived Cognitive Abilities16.0 units on a scale
STANDARD_DEVIATION 5.1
FACT-COG: Perceived Impairments on Quality of Life3.7 units on a scale
STANDARD_DEVIATION 3.8
Nuclear Factor kappa B (NF-kB1)171.7 fold change
STANDARD_DEVIATION 25.4
Pittsburgh Sleep Quality Index (PSQI)1.5 units on a scale
STANDARD_DEVIATION 0.8
Profile of Mood States Short Form - Anxiety (POMS-SF)9.2 units on a scale
STANDARD_DEVIATION 7.7
Profile of Mood States Short Form - Depression (POMS-SF)4.1 units on a scale
STANDARD_DEVIATION 4.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
13 Participants
Region of Enrollment
United States
14 participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
0 Participants
Tumor Protein 53 (TP53)12.3 fold change
STANDARD_DEVIATION 2.7
Wechsler Adult Intelligence Scale (WAIS-III) 3rdEdition -Digit Span Forward and Backward19.2 units on a scale
STANDARD_DEVIATION 4.8
Wechsler Adult Intelligence Scale (WAIS-III) 3rdEdition-letter/number Seq10.7 units on a scale
STANDARD_DEVIATION 3.2

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 14
other
Total, other adverse events
0 / 14
serious
Total, serious adverse events
0 / 14

Outcome results

Primary

Comments From Others (CogOth)

Comments from Others (CogOth) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 4 items. The range of values are 0-16 with lower scores signifying better outcomes.

Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupComments From Others (CogOth)0.2 units on a scaleStandard Deviation 0.4
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogOth 1.5 (2.1) 0.2 (0.4) \*-1.3 (1.7) .04~\*lower scores signifying better outcomes.p-value: 0.04t-test, 2 sided
Primary

Impact on Quality of Life (CogQOL)

Impact on Quality of Life (CogQOL) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 4 items. The range of values are 0-16 with lower scores signifying better outcomes.

Time frame: Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupImpact on Quality of Life (CogQOL)1.8 units on a scaleStandard Deviation 2.2
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogQOL 3.7 (3.8) 1.8 (2.2) \*-1.9 (1.6) .04~\*lower scores signifying better outcomes.p-value: 0.04t-test, 2 sided
Primary

Perceived Cognitive Abilities (CogPCA)

Perceived Cognitive Abilities (CogPCA) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 9 items. The range of values are 0-36 with higher scores signifying better outcomes.

Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupPerceived Cognitive Abilities (CogPCA)19.2 units on a scaleStandard Deviation 5.3
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCA 16.0 (5.1) 19.2 (5.3) 3.2 (0.2) .03p-value: 0.03t-test, 2 sided
Primary

Perceived Cognitive Impairments (CogPCI)

Perceived Cognitive Impairments (CogPCI) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 20 items. The range of values are 0-80 with lower scores signifying better outcomes.

Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupPerceived Cognitive Impairments (CogPCI)17.3 units on a scaleStandard Deviation 10.5
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCI 25.4 (14.2) 17.3 (10.5) \*-8.1 (3.7) .01~\*reduction in scores indicate improvement.p-value: 0.01t-test, 2 sided
Primary

Pittsburg Sleep Quality Index (PSQI)

The PSQI is a 19-item self-report questionnaire designed to assess sleep quality and disturbances over a I-month interval. The Pittsburgh Sleep Quality Index (PSQI): 19 items assess sleep, including subscales for subjective sleep quality, sleep latency, sleep duration, sleep disturbance, habitual sleep efficiency, daytime dysfunction and use of sleep medications. A global PSQI score \>5 distinguishes good from poor sleepers. Lower scores mean better outcomes.

Time frame: Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupPittsburg Sleep Quality Index (PSQI)0.9 units on a scaleStandard Deviation 0.7
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value PSQI 1.5 (0.8) 0.9 (0.7) \*-0.6 (0.1) .03~\*Lower scores mean better outcomes.p-value: 0.03t-test, 2 sided
Primary

Profile of Mood States Short Form (POMS-SF) - Anxiety

The POMs-SF consists of 37 items, adjectives scored on a 5-point Likert scale. POMS consists of the Total Mood Disturbance (TMD) dimensions (tension-anxiety; depression-dejection; anger-hostility; confusion-bewilderment. This pilot study reported results for the tension-anxiety TMD dimensions (12 items). Lower scores mean better outcomes.

Time frame: Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupProfile of Mood States Short Form (POMS-SF) - Anxiety4.2 units on a scaleStandard Deviation 3.7
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Anxiety 9.2 (7.7) 4.2 (3.7) \*-5.0 (4.0) .05~\*Lower scores mean better outcomes.p-value: 0.05t-test, 2 sided
Primary

Profile of Mood States Short Form (POMS-SF) - Depression

The POMs-SF consists of 37 items, adjectives scored on a 5-point Likert scale. POMS consists of the Total Mood Disturbance (TMD) dimensions (tension-anxiety; depression-dejection; anger-hostility; confusion-bewilderment. This pilot study reported results for the depression-dejection TMD dimension (12 items). Lower scores mean better outcomes.

Time frame: Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupProfile of Mood States Short Form (POMS-SF) - Depression2.0 units on a scaleStandard Deviation 3
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Depression 4.1 (4.9) 2.0 (3.0) \*-2.1 (1.9) .08~\*Lower scores mean better outcomes.p-value: 0.08t-test, 2 sided
Primary

Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Digit Span Forward and Backward

WAIS-III): Digit Span Forward and Backward measures working memory using numbers in a series recall. The scoring range is 0 to 30 with higher scores meaning better outcomes.

Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupWechsler Adult Intelligence Scale-Third Edition (WAIS-III): Digit Span Forward and Backward19.7 units on a scaleStandard Deviation 4.4
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value~WAIS-III Digit Span Forward and Backward 19.2 (4.8) 19.7 (4.4) 0.5 (0.4) .60p-value: 0.6t-test, 2 sided
Primary

Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Letter-Number Sequencing

WAIS-III: Letter-Number Sequencing measures working memory using letters and numbers in sequence recall. The scoring range is 0 to 21 with higher scores meaning better outcomes.

Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupWechsler Adult Intelligence Scale-Third Edition (WAIS-III): Letter-Number Sequencing12.7 units on a scaleStandard Deviation 2.8
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value WAIS-III Letter/Number 10.7 (3.2) 12.7 (2.8) 2.0 (0.4) .01p-value: 0.01t-test, 2 sided
Secondary

Brain Derived Neurotropic Factor (BDNF) Gene Expression

The BDNF gene regulates synaptic plasticity associated with cognitive functioning. Increased levels of BDNF gene expression are associated with improved cognitive functioning. Blood samples were collected post-intervention for RNA Sequencing to measure RNA levels as indicators of gene expression. Higher scores mean better outcomes.

Time frame: Measures data on gene expression were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupBrain Derived Neurotropic Factor (BDNF) Gene Expression0.30 fold changeStandard Deviation 0.7
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value BDNF 0.11 (0.9) 0.30 (0.7) 0.19 (0.2) .30~Higher scores mean better outcomes.p-value: 0.3t-test, 2 sided
Secondary

Nuclear Factor Kappa B (NF-kB1) Gene Expression

Decreased levels of NF-kB1 gene expression are associated with improvements in managing chronic stress. Blood samples were collected post-intervention for RNA Sequencing to measure RNA levels as indicators of gene expression. Lower scores indicate better outcomes.

Time frame: Measures data on gene expression were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupNuclear Factor Kappa B (NF-kB1) Gene Expression173.7 fold changeStandard Deviation 21.6
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value NF-kB1 171.7 (25.4) 173.7 (21.6) 2.0 (3.8) .80~Higher scores mean better outcomes.p-value: 0.8t-test, 2 sided
Secondary

Tumor Protein 53 (TP53) Gene Expression

Increased TP53 gene expression is associated with suppressing cancer growth. Blood samples were collected post-intervention for RNA Sequencing to measure RNA levels as indicators of gene expression. Higher scores mean better outcomes.

Time frame: Measures data on gene expression were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

ArmMeasureValue (MEAN)Dispersion
Meditative Movement (MM) GroupTumor Protein 53 (TP53) Gene Expression13.1 fold changeStandard Deviation 5.5
Comparison: Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value TP53 12.3 (2.7) 13.1 (5.5) 0.8 (2.8) .61p-value: 0.61t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026