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

Wake Forest University (WFU)

Status: Completed

Conditions: Prognostic Stage IA Breast Cancer AJCC v8; Grade 1 Peripheral Sensory Neuropathy, CTCAE; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Grade 2 Peripheral Sensory Neuropathy, CTCAE; Prognostic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Grade 1 Peripheral Motor Neuropathy, CTCAE; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Grade 2 Peripheral Motor Neuropathy, CTCAE

Treatments: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Best Practice; Procedure: Acupuncture Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03505671

P30CA012197 (U.S. NIH Grant/Contract)

NCI-2018-00586 (Registry Identifier)

CCCWFU 97118 (Other Identifier)

IRB00049061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Group 1 (acupuncture)

Experimental group

Description:

Participants undergo 8 45-minute acupuncture treatments over 10 weeks.

Treatment:

Procedure: Acupuncture Therapy

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Group 2 (usual care)

Active Comparator group

Description:

Participants receive usual care.

Treatment:

Other: Best Practice

Other: Questionnaire Administration

Other: Quality-of-Life Assessment