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

NCT01996410 | Terminated Results

• 1 other identifier: OH1-13-00465
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (8)

Chemotherapy 1 Acupuncture

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.

Device: Acupuncture

Chemotherapy 2 Acupuncture

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.

Device: Acupuncture

Chemotherapy 3 Acupuncture

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.

Device: Acupuncture

Chemotherapy 4 Acupuncture

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.

Device: Acupuncture

Chemotherapy 1 No Acupuncture

NO INTERVENTION

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 No Acupuncture

NO INTERVENTION

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 No Acupuncture

NO INTERVENTION

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 No Acupuncture

NO INTERVENTION

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.

Interventions

Acupuncture DEVICE

Chemotherapy 1 Acupuncture; Chemotherapy 2 Acupuncture; Chemotherapy 3 Acupuncture; Chemotherapy 4 Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

Columbus Oncology and Hematology Associates

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Vomiting

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: John Elliott
• Organization: OhioHealth

John.Elliott@ohiohealth.com

614-566-3643

Study Officials

• Jeffery Bell, MD

  OhioHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Specialist- Medical Education

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 27, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 21, 2016
• Results First Posted: November 21, 2016

Record last verified: 2016-09

Locations

US (1)