Breast Cancer Stages I Through III
Conditions
Keywords
Breast Cancer, Acupuncture, Taxol, Cytoxan, Adriamycin, Taxotere, Carboplatin, Perjeta, Chemotherapy, Chemotherapy-induced nausea, vomiting, Chemotherapy-induced peripheral neuropathy, 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)
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.
Interventions
DEVICEAcupuncture
Sponsors
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chemotherapy 1 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.
Acupuncture
No Acupuncture- Standard of Care | 3 |
| Chemotherapy 2 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.
Acupuncture
No Acupuncture- Standard of Care | 3 |
| Chemotherapy 3 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.
Acupuncture
No Acupuncture- Standard of Care | 0 |
| Chemotherapy 4 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.
Acupuncture
No Acupuncture- Standard of Care | 0 |
| Chemotherapy 1 No 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.
Acupuncture
No Acupuncture- Standard of Care | 2 |
| Chemotherapy 2 No 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.
Acupuncture
No Acupuncture- Standard of Care | 2 |
| Chemotherapy 3 No 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.
Acupuncture
No Acupuncture- Standard of Care | 0 |
| Chemotherapy 4 No 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.
Acupuncture
No Acupuncture- Standard of Care | 0 |
| Total | 10 |
Baseline characteristics
| Characteristic | Total | Chemotherapy 1 Acupuncture | Chemotherapy 2 Acupuncture | Chemotherapy 1 No Acupuncture | Chemotherapy 2 No Acupuncture |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 2 participants | 2 participants | 0 participants | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 8 participants | 1 participants | 3 participants | 2 participants | 2 participants |
| Age, Continuous | 50.1 years STANDARD_DEVIATION 13.5 | 56.9 years STANDARD_DEVIATION 15.7 | 43.2 years STANDARD_DEVIATION 12 | 45.0 years STANDARD_DEVIATION 14.9 | 49.0 years STANDARD_DEVIATION 18.1 |
| Gender Female | 10 participants | 3 participants | 3 participants | 2 participants | 2 participants |
| Gender Male | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 10 participants | 3 participants | 3 participants | 2 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 2 | 0 / 3 | 0 / 2 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 | 0 / 3 | 0 / 2 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 15 months
Population: Per IRB guidelines, we were not permitted to analyze the 10 patients enrolled since we did not meet completed enrollment numbers.