Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Patients with Stage I-III Breast or Gastrointestinal Cancer
This trial studies how well acupuncture works in reducing chemotherapy-induced peripheral neuropathy in patients with stage I-III breast or gastrointestinal cancer. Acupuncture may help reduce chemotherapy-induced peripheral neuropathy and improve quality of life.
Inclusion Criteria
- Breast or gastrointestinal (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03505671.
PRIMARY OBJECTIVE:
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 if more chemotherapy is given or planned.
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: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients undergo 8 45-minute acupuncture treatments over 10 weeks.
GROUP 2: Patients receive usual care.
After completion of study, patients are followed up at 30 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorNancy Elizabeth Avis
- Primary IDCCCWFU 97118
- Secondary IDsNCI-2018-00586
- ClinicalTrials.gov IDNCT03505671