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

NCT ID: NCT01996410

Last Updated: 2016-11-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Stages I Through III

Keywords

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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OhioHealth

OTHER

Sponsor Role lead

Responsible Party

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John Elliott

Research Specialist- Medical Education

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffery Bell, MD

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Locations

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Columbus Oncology and Hematology Associates

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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OH1-13-00465

Identifier Type: -

Identifier Source: org_study_id