An interventional study of Acupuncture Therapy and Best Practice in Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8 and Anatomic Stage IB Breast Cancer AJCC v8, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
The goal of this study is to obtain preliminary evidence of the effect of 8 acupuncture treatments over 10 weeks in breast and GI cancer patients who are currently receiving or recently completed active neurotoxic chemotherapy and have clinically documented grade 1 or 2 neuropathy.
PRIMARY OBJECTIVES:
I. To obtain preliminary evidence of the clinical effects of acupuncture compared to usual care on the change in sensory neuropathic pain as measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 item (20) sensory subscale.
SECONDARY OBJECTIVES:
I. Change in the motor and autonomic neuropathic pain subscores on the EORTC QLQ-CIPN20.
II. Change in patient-reported assessment of numbness and tingling using the 2-item Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) measure.
III. Preventing the escalation of CIPN from grade 1 or 2 to a higher grade. IV. Amount and intensity of planned chemotherapy relative to completed chemotherapy.
V. Effect on sensory and motor nerve function via nerve conduction studies (NCS) (e.g. conduction velocity, latency, and amplitude).
VI. Effect on peripheral nerve swelling via nerve ultrasound (e.g. cross sectional area, CSA).
EXPLORATORY OBJECTIVES:
I. To obtain preliminary evidence on phenotypic differences between African-American and non African-American (A-A) (i.e., white, Asian, etc.) with regard to presentation of CIPN as well as response to the intervention.
II. To obtain preliminary evidence of the effect of acupuncture on intraepidermal nerve fiber density (IENF) via skin biopsy.
III. To examine the associations among the peripheral nerve assessment measures (nerve conduction, peripheral nerve ultrasound, skin biopsy) and of the peripheral nerve assessment measures with the patient reported outcomes (EORTC QLQ-CIN20, PRO-CTCAE) at baseline, week 12, and for the change from baseline to week 12.
IV. To examine the association between expectations of the effectiveness of acupuncture to reduce peripheral neuropathy and baseline, 12 week, and change in patient-reported outcomes on the EORTC QLQ-CIPN20 and PRO-CTCAE.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP 1: Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
GROUP 2: Participants receive usual care.
After completion of study treatment, participants are followed up at 12 weeks.
Exclusion Criteria:
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Procedure: Acupuncture Therapy · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Participants receive usual care.
Other: Best Practice · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Undergo acupuncture therapy
Also known as: Acupuncture
Receive usual care
Also known as: standard of care, standard therapy
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20)
Will estimate means and standard deviations by group for the EORTC QLQ-CIPN20 sensory subscale, the correlation between the two measures, and the within-person change. To estimate effect size, we will use an analysis of covariance (ANCOVA) model at week 12, which will include the group and the baseline value. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded) \[13\]. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
Time frame: Baseline up to week 12
Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
Time frame: Baseline up to week 12
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period.
Time frame: Baseline up to week 12
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period.
Time frame: Up to week 12
Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points
Time frame: Up to week 12
Number of Cycles of Completed Chemotherapy
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Nerve conduction studies measure impairment of electrical function in large peripheral nerves and measures amplitude and latency of neuronal signaling. Ranging from 0.1 μm to 20 μm. Reduction in the amplitude indicates axonal damage.
Time frame: Up to week 12
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
Nerve Fiber Density in the Skin
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
| Milestone | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Started | 11 | 12 |
| Completed | 8 | 11 |
| Not completed | 3 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
Will estimate means and standard deviations by group for the EORTC QLQ-CIPN20 sensory subscale, the correlation between the two measures, and the within-person change. To estimate effect size, we will use an analysis of covariance (ANCOVA) model at week 12, which will include the group and the baseline value. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded) \[13\]. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
| score on a scale | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Baseline | 16.7 ± 3.7 | 17.5 ± 3.0 |
| Week 12 | 13.7 ± 2.7 | 14.8 ± 5.2 |
| Week 12 - Baseline (Change) | -2.9 ± 4.2 | -2.5 ± 5.8 |
Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
| score on a scale | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Baseline EORTC Subscale | 11.1 ± 3.2 | 11.3 ± 2.1 |
| Week 12 EORTC Subscale | 11.0 ± 1.8 | 11.1 ± 3.3 |
| Week 12 - Baseline (Change) EORTC Subscale | 0.1 ± 2.2 | -0.1 ± 2.7 |
| Baseline EORTC Autonomic Subscale | 2.7 ± 0.9 | 2.8 ± 0.8 |
| Week 12 - EORTC Autonomic Subscale | 2.4 ± 0.7 | 2.3 ± 0.5 |
| Week 12 - Baseline EORTC Autonomic Subscale | -0.3 ± 1.1 | -0.5 ± 0.9 |
Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period.
| Participants | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Baseline - Numbness or Tingling Severity (None 1) | 4 | 2 |
| Baseline - Numbness or Tingling Severity (Mild 2) | 3 | 8 |
| Baseline - Numbness or Tingling Severity (Moderate 3) | 2 | 1 |
| Baseline - Numbness or Tingling Severity (Severe 4) | 1 | 1 |
| Baseline - Numbness or Tingling Severity (Very severe 5) | 0 | 0 |
| Week 12 - Numbness or Tingling Severity (None 1) | 1 | 2 |
| Week 12 - Numbness or Tingling Severity (Mild 2) | 6 | 4 |
| Week 12 - Numbness or Tingling Severity (Moderate 3) | 2 | 3 |
| Week 12 - Numbness or Tingling Severity (Severe 4) | 0 | 0 |
| Week 12 - Numbness or Tingling Severity (Very severe 5) | 0 | 0 |
| Baseline - Numbness or Tingling Interference - Not at all (1) | 4 | 1 |
| Baseline - Numbness or Tingling Interference - A little bit (2) | 2 | 7 |
| Baseline - Numbness or Tingling Interference - Somewhat (3) | 2 | 2 |
| Baseline - Numbness or Tingling Interference -Quite a bit (4) | 2 | 2 |
| Baseline - Numbness or Tingling Interference - Very much (5) | 0 | 0 |
| Week 12 - Numbness or Tingling Interference - Not at all (1) | 3 | 7 |
| Week 12 - Numbness or Tingling Interference - A little bit (2) | 5 | 1 |
| Week 12 - Numbness or Tingling Interference - Somewhat (3) | 1 | 3 |
| Week 12 - Numbness or Tingling Interference - Quite a bit (4) | 0 | 0 |
| Week 12 - Numbness or Tingling Interference - Very much (5) | 0 | 0 |
| Week 12 - Baseline (Change) Numbness or Tingling Severity (Decreased, less than or equal to -1) | 5 | 7 |
| Week 12 - Baseline (Change) Numbness or Tingling Severity - Same (0) | 3 | 1 |
| Week 12 - Baseline (Change) Numbness or Tingling Severity (Increased, >/= 1) | 1 | 3 |
| Week 12 - Baseline (Change) Numbness or Tingling Interference - (Decreased, </= -1) | 3 | 7 |
| Week 12 - Baseline (Change) Numbness or Tingling Interference - (Same - 0) | 5 | 3 |
| Week 12 - Baseline (Change) Numbness or Tingling Interference - (Increased, >/= -1) | 1 | 1 |
The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period.
| Participants | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Baseline - Grade 1 Numbness or Tingling | 10 | 10 |
| Baseline - Grade 2 Numbness or Tingling | 1 | 2 |
| Baseline - Grade 3 Numbness or Tingling | 0 | 0 |
| Week 12 - Grade 1 Numbness or Tingling | 7 | 9 |
| Week 12 Grade 2 Numbness or Tingling | 1 | 1 |
| Week 12 Grade 3 Numbness or Tingling | 0 | 1 |
| Week 12 - Baseline Numbness or Tingling Severity Decreased (</= 1) | 0 | 0 |
| Week 12 - Baseline Numbness or Tingling Severity Same (0) | 7 | 9 |
| Week 12 - Baseline Numbness or Tingling Severity Increased (>/= 1) | 1 | 2 |
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points
| Participants | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Chemotherapy dose standard | 6 | 7 |
| Chemotherapy dose decreased due to chemotherapy induced peripheral neuropathy | 3 | 3 |
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
| cycles | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Number of Cycles of Completed Chemotherapy | 4.4 ± 0.7 | 4.2 ± 1.0 |
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
| meters squared | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Baseline - Cross sectional area - sural | 3.1 ± 1.5 | 2.8 ± 0.7 |
| Baseline - Cross sectional area - median | 14.2 ± 6.3 | 12.7 ± 3.3 |
| Week 12 - Cross sectional area - sural | 3.0 ± 1.3 | 3.0 ± 1.2 |
| Week 12 - Cross sectional area - median | 14.6 ± 7.5 | 11.9 ± 2.8 |
| Week 12 - Baseline - Cross sectional area - sural (Change) | -0.4 ± 1.0 | 0.1 ± 1.3 |
| Week 12 - Baseline - Cross sectional area - median (Change) | 0.1 ± 1.5 | -1.0 ± 2.0 |
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Nerve conduction studies measure impairment of electrical function in large peripheral nerves and measures amplitude and latency of neuronal signaling. Ranging from 0.1 μm to 20 μm. Reduction in the amplitude indicates axonal damage.
| micrometers | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Baseline - Amplitude (sural) | 9.5 ± 5.0 | 9.5 ± 7.6 |
| Week 12 - Amplitude (sural) | 8.8 ± 3.6 | 10.9 ± 7.8 |
| Week 12 - Baseline Amplitude (sural) | -1.5 ± 4.6 | 0.7 ± 1.8 |
| Baseline - Amplitude - Tibial, ankle | 13.3 ± 5.6 | 11.0 ± 3.8 |
| Week 12 - Amplitude - Tibial, ankle | 12.4 ± 5.2 | 11.5 ± 3.5 |
| Week 12 - Baseline - Amplitude - Tibial, ankle (Change) | -1.5 ± 1.9 | -0.2 ± 1.7 |
| Baseline - Amplitude - Tibial, pop fossa | 8.5 ± 5.2 | 7.8 ± 3.7 |
| Week 12 - Amplitude - Tibial, pop fossa | 10.0 ± 4.4 | 7.9 ± 3.0 |
| Week 12 - Baseline - Amplitude - Tibial, pop fossa (Change) | 1.0 ± 3.4 | -0.8 ± 1.9 |
| Baseline - Amplitude - median, wrist | 9.6 ± 3.6 | 10.3 ± 2.8 |
| Week 12 - Amplitude - median, wrist | 10.1 ± 4.4 | 11.2 ± 2.7 |
| Week 12 - Baseline - Amplitude - median, wrist (Change) | 0.1 ± 3.3 | 0.4 ± 2.4 |
| Baseline - Amplitude - median, elbow | 9.3 ± 3.7 | 10.0 ± 2.8 |
| Week 12 - Amplitude - median, elbow | 9.3 ± 4.0 | 10.8 ± 2.7 |
| Week 12 - Baseline Amplitude - median, elbow (Change) | -0.3 ± 3.1 | 0.5 ± 2.3 |
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
| milliseconds | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Baseline - Latency Sural | 3.4 ± 0.6 | 3.4 ± 0.6 |
| Week 12 - Latency Sural | 3.4 ± 0.6 | 3.3 ± 0.6 |
| Week 12 -Baseline - Latency Sural (Change) | 0.0 ± 0.7 | 0.0 ± 0.3 |
| Baseline - Latency tibial, ankle | 3.6 ± 0.3 | 4.0 ± 0.5 |
| Week 12 - Latency tibial, ankle | 3.6 ± 0.5 | 3.8 ± 0.6 |
| Week 12 - Baseline Latency tibial, ankle (Change) | -0.1 ± 0.8 | -0.2 ± 0.4 |
| Baseline - Latency tibial, pop | 11.5 ± 1.0 | 11.7 ± 1.2 |
| Week 12 - Latency tibial, pop | 11.2 ± 1.1 | 11.5 ± 1.2 |
| Week 12 - Baseline Latency tibial, pop | -0.2 ± 0.6 | 0.1 ± 0.4 |
| Baseline - Latency median wrist | 4.0 ± 1.1 | 3.7 ± 0.5 |
| Week 12 - Latency median wrist | 4.4 ± 1.9 | 3.7 ± 0.5 |
| Week 12 - Baseline Latency median wrist (Change | 0.5 ± 1.0 | -0.1 ± 0.4 |
| Baseline - Latency median elbow | 7.8 ± 1.5 | 7.5 ± 0.7 |
| Week 12 - Latency median elbow | 8.2 ± 2.5 | 7.5 ± 0.7 |
| Week 12 - Baseline - Latency median elbow (Change) | 0.4 ± 1.2 | 0.0 ± 0.6 |
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
| meters per second | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Baseline - Velocity Sural | 51.1 ± 3.0 | 45.9 ± 3.8 |
| Week 12 - Velocity Sural | 50.5 ± 5.6 | 48.7 ± 4.2 |
| Week 12 - Baseline Velocity Sural (Change) | -1.0 ± 6.6 | 2.2 ± 3.6 |
| Baseline - Velocity Tibial | 49.1 ± 3.3 | 50.3 ± 5.1 |
| Week 12 - Velocity Tibial | 51.1 ± 5.6 | 49.4 ± 5.4 |
| Week 12 - Baseline - Velocity Tibial (Change) | 2.1 ± 4.3 | -2.0 ± 2.3 |
| Baseline - Velocity Median | 55.5 ± 3.7 | 54.2 ± 4.1 |
| 12 Weeks - Velocity Median | 55.3 ± 5.9 | 55.5 ± 2.8 |
| Week 12 - Baseline - Velocity Median (Change) | -0.6 ± 5.3 | 0.1 ± 2.9 |
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
| fibers per millimeter | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| Baseline - Nerve fiber density, distal leg | 7.8 ± 3.2 | 8.3 ± 3.3 |
| Week 12 - Nerve fiber density, distal leg | 3.5 ± 0.7 | 4.3 ± 1.7 |
| Week 12 - Baseline - Nerve fiber density, distal leg | -5.1 ± 2.8 | -4.5 ± 3.0 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 (Acupuncture) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Group 2 (Usual Care) | 1/12 (8.3%) | 0/12 (0%) | 1/12 (8.3%) |
| Event | Group 1 (Acupuncture) | Group 2 (Usual Care) |
|---|---|---|
| BruisingInjury, poisoning and procedural complications | 0/11 | 1/12 |
| Age, Continuous(years) | Group 1 (Acupuncture) | Group 2 (Usual Care) | Total |
|---|---|---|---|
| Mean | 51.0 ± 10.6 | 56.8 ± 12.5 | 56.5 ± 11.7 |
| Sex: Female, Male(Participants) | Group 1 (Acupuncture) | Group 2 (Usual Care) | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 (Acupuncture) | Group 2 (Usual Care) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 11 | 12 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1 (Acupuncture) | Group 2 (Usual Care) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 9 | 8 | 17 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Group 1 (Acupuncture) | Group 2 (Usual Care) | Total |
|---|---|---|---|
| United States | 11 | 12 | 23 |
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Wake Forest University Health Sciences