Clinical trial NCT03505671: Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer
Official title: Acupuncture for Chemotherapy-Induced Peripheral Neuropathy Among Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Grade 1 Peripheral Motor Neuropathy, CTCAE
Grade 1 Peripheral Sensory Neuropathy, CTCAE
Grade 2 Peripheral Motor Neuropathy, CTCAE
Grade 2 Peripheral Sensory Neuropathy, CTCAE
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-04-23
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline up to week 12
Secondary outcomes:
measure: Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
timeFrame: Baseline up to week 12
measure: Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
timeFrame: Baseline up to week 12
measure: CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
timeFrame: Up to week 12
measure: Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy
timeFrame: Up to week 12
measure: Number of Cycles of Completed Chemotherapy
timeFrame: Up to week 12
measure: Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)
timeFrame: Up to week 12
measure: Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
timeFrame: Up to week 12
measure: Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
timeFrame: Up to week 12
measure: Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
timeFrame: Up to week 12
measure: Nerve Fiber Density in the Skin
timeFrame: Up to week 12
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Nancy Avis
role: PRINCIPAL_INVESTIGATOR
References: