Trial Outcomes & Findings for The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients (NCT NCT01996410)

NCT ID: NCT01996410

Last Updated: 2016-11-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

15 months

Results posted on

2016-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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	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
Overall Study STARTED	3	3	2	2
Overall Study COMPLETED	3	3	2	2
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy 1 Acupuncture n=3 Participants 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	Chemotherapy 2 Acupuncture n=3 Participants 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	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	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	Chemotherapy 1 No Acupuncture n=2 Participants 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	Chemotherapy 2 No Acupuncture n=2 Participants 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	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	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	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	—	—	0 participants n=21 Participants	0 participants n=10 Participants	—	—	0 participants n=42 Participants
Age, Categorical Between 18 and 65 years	1 participants n=5 Participants	3 participants n=7 Participants	—	—	2 participants n=21 Participants	2 participants n=10 Participants	—	—	8 participants n=42 Participants
Age, Categorical >=65 years	2 participants n=5 Participants	0 participants n=7 Participants	—	—	0 participants n=21 Participants	0 participants n=10 Participants	—	—	2 participants n=42 Participants
Age, Continuous	56.9 years STANDARD_DEVIATION 15.7 • n=5 Participants	43.2 years STANDARD_DEVIATION 12.0 • n=7 Participants	—	—	45.0 years STANDARD_DEVIATION 14.9 • n=21 Participants	49.0 years STANDARD_DEVIATION 18.1 • n=10 Participants	—	—	50.1 years STANDARD_DEVIATION 13.5 • n=42 Participants
Gender Female	3 participants n=5 Participants	3 participants n=7 Participants	—	—	2 participants n=21 Participants	2 participants n=10 Participants	—	—	10 participants n=42 Participants
Gender Male	0 participants n=5 Participants	0 participants n=7 Participants	—	—	0 participants n=21 Participants	0 participants n=10 Participants	—	—	0 participants n=42 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	—	—	2 participants n=21 Participants	2 participants n=10 Participants	—	—	10 participants n=42 Participants

PRIMARY outcome

Timeframe: 15 months

Population: Per IRB guidelines, we were not permitted to analyze the 10 patients enrolled since we did not meet completed enrollment numbers.

Outcome measures

Other adverse events

Adverse event data not reported

Additional Information

John Elliott

OhioHealth

Phone: 614-566-3643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place