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

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ClinicalTrials.gov Identifier: NCT03505671
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This pilot trial studies how well acupuncture works in reducing chemotherapy-induced peripheral neuropathy in participants with stage I-III breast cancer. Acupuncture may help reduce chemotherapy-induced peripheral neuropathy and improve quality of life.

Condition or disease Intervention/treatment Phase
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 Procedure: Acupuncture Therapy Other: Best Practice Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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 intraepidermal nerve fiber density (IENF) via skin biopsy. VII. 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 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.

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Acupuncture for Chemotherapy-Induced Peripheral Neuropathy Among Breast Cancer Patients
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 (acupuncture)
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Procedure: Acupuncture Therapy
Undergo acupuncture therapy
Other Name: Acupuncture

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group 2 (usual care)
Participants receive usual care.
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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) [ Time Frame: Baseline up to week 12 ]
    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.


Secondary Outcome Measures :
  1. Motor and autonomic pain subscores on the EORTC QLQ-CIPN20 [ Time Frame: Baseline up to week 12 ]
    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.

  2. Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) measure of numbness and tingling [ Time Frame: Baseline up to week 12 ]
    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.

  3. CIPN as measured by National Cancer Institute (NCI)-CTCAE 5.0 [ Time Frame: Up to week 12 ]
    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.

  4. Dose of planned chemotherapy and completed chemotherapy [ Time Frame: Up to week 12 ]
    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.

  5. Number of cycles of planned chemotherapy and completed chemotherapy [ Time Frame: Up to week 12 ]
    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.

  6. Cross sectional area (CSA) of peripheral nerves as determined by ultrasound [ Time Frame: Up to week 12 ]
    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.

  7. Amplitude of nerve response derived from nerve conduction studies (NCS) (sural, tibial, and median) [ Time Frame: Up to week 12 ]
    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.

  8. Distal latency of nerve response derived from NCS (sural, tibial, and median) [ Time Frame: Up to week 12 ]
    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.

  9. Conduction velocity of nerve response derived from NCS (sural, tibial, and median) [ Time Frame: Up to week 12 ]
    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.

  10. Nerve fiber density in the skin [ Time Frame: Up to week 12 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer stage I-III
  • Currently receiving taxane-based chemotherapy (either adjuvant or neoadjuvant)
  • 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 pre-existing peripheral neuropathy due to diabetes, human immunodeficiency virus (HIV), or other conditions
  • Unable to provide medical history
  • Pregnant
  • Unwilling to receive acupuncture or unable to travel for treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505671


Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Nancy E. Avis    336-716-6974    navis@wakehealth.edu   
Principal Investigator: Nancy E. Avis         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nancy Avis Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03505671     History of Changes
Other Study ID Numbers: IRB00049061
NCI-2018-00586 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 97118 ( Other Identifier: Wake Forest University Health Sciences )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Neuritis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases