Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer

Wake Forest University Health Sciences23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Breast and GI cancer stage I-III * Currently receiving or recently completed neurotoxic chemotherapy (either adjuvant or neoadjuvant). Currently is defined as including up until when the next cycle would be delivered, that is if the patient is getting chemotherapy every week, this would include a week after their last treatment; if the patient is getting treatment every 2 weeks, this would include 2 weeks after their last treatment; if the patient is getting treatment every 3 weeks, this would include 3 weeks after their last treatment, etc. Recently completed is defined as 6 weeks after this time period. For example, if a patient was getting chemotherapy every week, this would include seven weeks after their last treatment; if the patient was getting treatment every 2 weeks, this would include 8 weeks after their last treatment; if the patient were getting treatment every 3 weeks, this would include 9 weeks after their last treatment, etc. * Clinical symptoms of peripheral neuropathy of grade 1 or grade 2 as measured by the National Cancer Institute (NCI)-CTCAE * Ability and willingness to understand and sign an informed consent Exclusion Criteria: * Self-reported or documented history of UNRESOLVED pre-existing peripheral neuropathy due to diabetes, human immunodeficiency virus (HIV), or other conditions. * Unable to provide medical history. * Male patients. * Pregnant. * Unwilling to receive acupuncture or unable to travel for treatments.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Time frame: Up to week 12

Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)

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)

Time frame: Up to week 12

Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)

Time frame: Up to week 12

Nerve Fiber Density in the Skin

Time frame: Up to week 12

Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes