Breast Cancer Stages I Through IIINCT01996410
The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
A study testing Acupuncture in people with Breast Cancer Stages I Through III, run by OhioHealth at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stages I Through III
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbus Oncology and Hematology Associates
Columbus, Ohio, 43214
About this study
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
- Being tested
- Acupuncture
- 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)
- Medical subject headings
- Breast Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionMay 2015
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer Stages I Through IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Elliott, OhioHealth
- Investigators
- Jeffery Bell, MD, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996410
- Sponsor's protocol ID
- OH1-13-00465
- Status last verified
- Sep 2016
- First submitted
- 11 Nov 2013
- Last updated
- 21 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01996410
- Acronym / sponsor ID
- OH1-13-00465
- Conditions
- Breast Cancer Stages I Through III
- Keywords
- Breast Cancer, Acupuncture, Taxol, Cytoxan, Adriamycin, Taxotere, Carboplatin, Perjeta
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 21 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy 1 Acupuncture | Active comparator | Device: AcupunctureChemotherapy 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 Acupuncture | Active comparator | Device: AcupunctureChemotherapy 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 Acupuncture | Active comparator | Device: AcupunctureChemotherapy 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 Acupuncture | Active comparator | Device: AcupunctureChemotherapy 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Device | Chemotherapy 1 Acupuncture, Chemotherapy 2 Acupuncture, Chemotherapy 3 Acupuncture, Chemotherapy 4 Acupuncture |
Primary outcome
MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment
Time frame: 15 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Bell, MD principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Breast Cancer Stages I Through III, run by OhioHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.