The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients

Not Applicable

Terminated

• Conditions: Breast Cancer Stages I Through III

• Registration Number: NCT01996410
• Lead Sponsor: OhioHealth

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Primary Completion: 2015-01
• Study Completion: 2015-05
• Results First Submitted: 2016-07-15
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-29
• Last Update Submitted: 2016-09-29
• Results First Posted: 2016-11-21
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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 continuous positive airway pressure (CPAP)
• Other acupuncture treatment within one month of enrollment
• Acupuncture treatment for chemotherapy in the past
• Current participation in any other research studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment	15 months	The investigators will first plot M.D. Anderson Symptom Inventory Core Items (MDASI) scores over time for the acupuncture and control groups to visually inspect for differences between the two groups. The investigators will further evaluate the difference in MDASI scores for the two groups using linear mixed models that account for multiple measurements within a single patient. A mixed model is preferable to a repeated measures ANOVA in this case, as it allows for missing time points within a single subject without eliminating that subject from the analysis.; Additionally, the investigators are able to specify how our time points are correlated within patients rather than assuming equal correlation across time points. The MDASI is comprised of 13 separate items that are not summative; therefore, the significance level for all statistical tests will be set at 0.003 (0.05/13) to account for multiple comparisons.

Trial Locations

Locations (1)

Columbus Oncology and Hematology Associates; 🇺🇸 Columbus, Ohio, United States