The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
This trial is active, not recruiting.
|Condition||breast cancer stages i through iii|
|Treatments||acupuncture, no acupuncture- standard of care|
|Start date||November 2013|
|End date||January 2015|
|Trial size||66 participants|
|Trial identifier||NCT01996410, OH1-13-00465|
The goal of this study is to determine if acupuncture improves multiple symptoms associated with chemotherapy on the MD Anderson Symptom Inventory (MDASI): nausea, vomiting, fatigue, anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and peripheral neuropathy (see statistical section). The investigators hypothesis is that acupuncture will result in lower MDASI scores over the course of chemotherapy for the acupuncture group vs. control group.
|Intervention model||parallel assignment|
MDASI score of chemotherapy-associated symptoms with acupuncture treatment
time frame: 15 months
Female participants at least 18 years old.
Inclusion Criteria: - 18 years or older - English speaking/reading/writing - Breast cancer stages I through III - Any performance status suitable for chemotherapy as determined by the physician - Primary or secondary chemotherapy, but enrolling patients prior to a chemotherapy regimen regardless of previous radiation therapy exposure and/or previous mastectomy. - Scheduled to receive either of the following two regimens: - Adriamycin (60 mg/m2), Cytoxan (600 mg/m2), Taxol (175 mg/m2) - Adriamycin (60 mg/m2), Cytoxan (600 mg/m2), Taxol (80 g/m2) - Taxotere (75mg/m2), Cytoxan (600 mg/m2) - Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) Exclusion Criteria: - History of narcolepsy - Sleep apnea requiring CPAP - Other acupuncture treatment within one month of enrollment - Acupuncture treatment for chemotherapy in the past - Current participation in any other research studies
|Official title||The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients|
|Principal investigator||Jeffery Bell, MD|
Call for more information