Breast Cancer Stages I Through III Clinical Trial
Official title:
The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
| Verified date | March 2015 |
| Source | OhioHealth |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 66 |
| Est. completion date | |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Columbus Oncology and Hematology Associates | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| OhioHealth |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MDASI score of chemotherapy-associated symptoms with acupuncture treatment | 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. |
15 months | No |