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

Not Applicable

Terminated

Conditions: Breast Cancer Stages I Through III

Interventions: Device: Acupuncture

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

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

Arm && Interventions

Group	Intervention	Description
Chemotherapy 2 Acupuncture	Acupuncture	Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental ("acupuncture") group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.
Chemotherapy 1 Acupuncture	Acupuncture	Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental ("acupuncture") group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.
Chemotherapy 3 Acupuncture	Acupuncture	Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental ("acupuncture") group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.
Chemotherapy 4 Acupuncture	Acupuncture	Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental ("acupuncture") group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.

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.

Secondary Outcome Measures