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

Breast Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Breast Cancer

Colorectal Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Acupuncture using SeirinĀ® needlesParticipants will receive acupuncture weekly until the end of chemotherapy. Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points , and immediately affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion.

Device:Sham Acupuncture using Park Sham placebo acupuncture deviceParticipants will receive sham acupuncture until the end of chemotherapy. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape next to the needles. In addition, she will tap a mock plastic needle guiding tube on the surface of each of the 8 true points in the arm and leg to produce some discernible sensation and then immediately apply a needle with a piece of adhesive tape to the dermal surface, without needle insertion.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Standard CarePatients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. 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.

AcupuncturePatients 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.

Sham AcupuncturePatients 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.

Study Status

Terminated

Start Date: February 2013

Completed Date: April 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Proportion of Colorectal and Breast Cancer Patients in Each Arm Who Require Dose Reduction or Discontinuation Due to Chemotherapy-induced Peripheral Neuropathy.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Ting Bao, MD, DABMA

Lead Sponsor: University of Maryland

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01881932

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