Overview

This trial is active, not recruiting.

Condition breast cancer stages i through iii
Treatments acupuncture, no acupuncture- standard of care
Sponsor OhioHealth
Start date November 2013
End date January 2015
Trial size 66 participants
Trial identifier NCT01996410, OH1-13-00465

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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
(Active Comparator)
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
(Active Comparator)
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
(Active Comparator)
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

Primary Outcomes

Measure
MDASI score of chemotherapy-associated symptoms with acupuncture treatment
time frame: 15 months

Eligibility Criteria

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

Additional Information

Official title The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
Principal investigator Jeffery Bell, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by OhioHealth.