Breast Cancer Clinical Trial
Official title:
Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients
Verified date | November 2019 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 19 |
Est. completion date | April 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Marlene & Stewart Greenebaum Cancer Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Colorectal and Breast Cancer Patients in Each Arm Who Require Dose Reduction or Discontinuation Due to Chemotherapy-induced Peripheral Neuropathy. | 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. | Week 12 |
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