Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01881932
Status:
TERMINATED
Last Update Posted:
2019-11-07
First Post:
2013-03-13
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:
University of Maryland Baltimore
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 N60 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 patients 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 patients 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 FACTGOG-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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCC1232 | OTHER | University of Maryland Greenebaum Cancer Center | None |