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

Primary Purpose

Breast Cancer Stages I Through III

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
OhioHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Stages I Through III focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Columbus Oncology and Hematology Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

No Intervention

No Intervention

No Intervention

Arm Label

Chemotherapy 1 Acupuncture

Chemotherapy 2 Acupuncture

Chemotherapy 3 Acupuncture

Chemotherapy 4 Acupuncture

Chemotherapy 1 No Acupuncture

Chemotherapy 2 No Acupuncture

Chemotherapy 3 No Acupuncture

Chemotherapy 4 No Acupuncture

Arm Description

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 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 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: 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.

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 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 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: 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2013
Last Updated
September 29, 2016
Sponsor
OhioHealth
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1. Study Identification

Unique Protocol Identification Number
NCT01996410
Brief Title
The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
Official Title
The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment.
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OhioHealth

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Stages I Through III
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy 1 Acupuncture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chemotherapy 2 Acupuncture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chemotherapy 3 Acupuncture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chemotherapy 4 Acupuncture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chemotherapy 1 No Acupuncture
Arm Type
No Intervention
Arm Description
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.
Arm Title
Chemotherapy 2 No Acupuncture
Arm Type
No Intervention
Arm Description
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.
Arm Title
Chemotherapy 3 No Acupuncture
Arm Type
No Intervention
Arm Description
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.
Arm Title
Chemotherapy 4 No Acupuncture
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery Bell, MD
Organizational Affiliation
OhioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbus Oncology and Hematology Associates
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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