Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 4:15 AM
Study NCT ID:
NCT01881932
Status:
TERMINATED
Last Update Posted:
2019-11-07
First Post:
2013-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (GCC1232)
Sponsor:
University of Maryland, Baltimore
Organization:
Study Overview
Official Title:
Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI has moved to another institution, which resulted in significant changes in the study design and study title.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| GCC1232 | OTHER | University of Maryland Greenebaum Cancer Center | View |