Status:
TERMINATED
Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (GCC1232)
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Breast Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01881932
Start Date
February 1 2013
End Date
April 1 2015
Last Update
November 7 2019
Active Locations (1)
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1
University of Maryland Marlene & Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201