Trials / Completed

CompletedNCT03505671

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

Acupuncture for Chemotherapy-Induced Peripheral Neuropathy Among Breast Cancer Patients

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 23 (actual)

Sponsor: Wake Forest University Health Sciences · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Acupuncture Therapy	Undergo acupuncture therapy
OTHER	Best Practice	Receive usual care
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2018-08-03
Primary completion: 2021-01-21
Completion: 2021-02-21
First posted: 2018-04-23
Last updated: 2022-06-01
Results posted: 2022-05-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03505671. Inclusion in this directory is not an endorsement.