Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (GCC1232)

Not Applicable

Terminated

Conditions: Breast Cancer
Colorectal Cancer

Interventions: Device: Sham Acupuncture using Park Sham placebo acupuncture device
Device: Acupuncture using Seirin® needles

Registration Number: NCT01881932

Lead Sponsor: University of Maryland, Baltimore

Brief Summary: In this study the investigators will assess how useful and safe acupuncture is in easing the pain, tingling and numbness that is caused by chemotherapy. The researchers hope this will prevent the need to reduce the amount of chemotherapy a patient receives.

Detailed Description: This is a single-center, pilot (phase IIb), randomized, standard care- and placebo (sham acupuncture)-controlled clinical trial (N=60) assessing the effects of acupuncture to prevent chemotherapy dose reduction due to chemotherapy-induced peripheral neuropathy (CIPN) and to elucidate the mechanism of action. Breast or colorectal cancer patients receiving neoadjuvant or adjuvant chemotherapy containing neurotoxic agents (taxanes or oxaliplatin) at the University of Maryland Marlene \& Stewart Greenebaum Cancer Center (UMGCC) will be screened for CIPN. Once these patients develop greater than or equal to National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 CIPN, they will be recruited for this study. Severity of CIPN as defined by NCI-CTC is listed in Appendix A. Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will then be randomly assigned to one of three arms: (A) real acupuncture, (B) sham acupuncture or (C) standard care. All patients will follow the same chemotherapy dose reduction algorithm (Appendix B). No concomitant anti-neuropathy medication is allowed. Patients in the intervention arms will be randomly assigned to undergo weekly real or sham acupuncture until the end of their chemotherapy. In these two arms, the patient, the patient's medical oncologist, pharmacist, research nurse, and study coordinator will be blinded to the treatment assignment. In standard care arm, patients will not receive additional therapy for CIPN. Their CIPN will be managed according to the standard chemotherapy dose reduction algorithm. In all arms, chemotherapy dose will be documented during the patient's scheduled chemotherapy sessions. The chemotherapy relative dose intensity (RDI) will be calculated at the end of their chemotherapy. Validated patient-reported outcome questionnaires: Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire and Neuropathy Pain Scale (NPS), described later, will be used to assess CIPN severity weekly in all patients until the end of their chemotherapy and at the 4 week follow up. Nerve conduction study will be performed by a neurologist at baseline and after chemotherapy is finished. Side effects from real or sham acupuncture will be recorded weekly. Approximately 4 ml of blood will be drawn from patients before each real or sham acupuncture treatment, or with routine weekly blood work check (in the standard care arm), at the end of chemotherapy, and at the 4 week follow up to measure changes in nerve growth factor and other neurotrophic factors such as brain-derived neurotrophic factor, neurotrophin-3, the insulin-like growth factors, and vascular endothelial growth factor. They will be analyzed in the cytokine lab at the University of Maryland School of Medicine (UMSOM).

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

Inclusion Criteria

Histologically proven stage I-III carcinoma of the breast OR histologically proven stage I-III colorectal carcinoma.
Receiving adjuvant or neoadjuvant chemotherapy that includes a taxane or oxaliplatin.
While on chemotherapy, develop greater than or equal to NCI-CTC grade 2 CIPN.
Eastern Cooperative Oncology Group performance status 0-2.
The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.

Exclusion Criteria

Prior acupuncture within one year of enrollment.
Known metastatic (stage IV) breast or colorectal cancer involvement.
Pre-existing peripheral neuropathy before chemotherapy is initiated
Currently taking anti-neuropathy medication such as gabapentin, or pregabalin.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Acupuncture	Sham Acupuncture using Park Sham placebo acupuncture device	Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive sham acupuncture until the end of their chemotherapy while following the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels.
Acupuncture	Acupuncture using Seirin® needles	Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive acupuncture until the end of their chemotherapy. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not receive additional therapy for CIPN.

Primary Outcome Measures

Name	Time	Method
Proportion of Colorectal and Breast Cancer Patients in Each Arm Who Require Dose Reduction or Discontinuation Due to Chemotherapy-induced Peripheral Neuropathy.	Week 12	The main objective is to assess efficacy and safety of acupuncture using Seirin acupuncture needles in colorectal and breast cancer patients who developed chemotherapy-induced peripheral neuropathy while receiving adjuvant/neoadjuvant chemotherapy. Safety will be assessed by recording side effects from acupuncture treatment. Efficacy will be assessed by measuring the proportion of patients in each arm who are required to undergo dose reduction or discontinuation due to chemotherapy-induced peripheral neuropathy.

Secondary Outcome Measures