Breast CancerNCT01050075
Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel
A study testing acupuncture therapy, questionnaire administration and management of therapy complications in people with Breast Cancer and Stage I Breast Cancer, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy. PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer
- What is being tested?
- acupuncture therapy, questionnaire administration and management of therapy complications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a history of histologically or cytologically confirmed stage I, II, or III breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (CTCAE criteria)
- Performance ECOG 0-2 (Karnofsky Performance Status >= 60%)
- Life expectancy of greater than 6 months
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with radiologically confirmed stage IV breast cancer
- Patients who had acupuncture in the previous 8 weeks
- Change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics ("change" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen)
- Patients with needle phobia
- Patients who experienced any peripheral neuropathy prior to chemotherapy
- Patients who have the potential for serious bleeding due to inherited diseases such as hemophilia
- Patients with diabetes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope
Duarte, California, 91010
City of Hope Medical Group Inc
Pasadena, California, 91105
About this study
Official title: A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy
RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy.
PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving paclitaxel.
Read the detailed description
PRIMARY OBJECTIVE:
- To explore the potential for the use of acupuncture to prevent a worsening of the nerve damage in patients (during treatment) due to paclitaxel as measured by a Neuropathic Pain Symptom Inventory.
SECONDARY OBJECTIVES:
- Evaluate the impact of acupuncture based on neurological assessment, quantitative sensory tests and nerve conduction tests.
II. Evaluate the improvement observed when treating patients for peripheral neuropathy (post-chemotherapy) with acupuncture based on the same metrics.
III. To correlate objective measures of neuropathy (nerve conduction, quantitative sensory tests, neuropathy composite score, and blood cytokine levels) with the subjective questionnaire/quality of life measures.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
ARM II: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
- Conditions
- Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Being tested
- acupuncture therapy, questionnaire administration, management of therapy complications
- Keywords
- male breast cancer, neurotoxicity, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture therapyOther
Also called acupuncture
acupuncture therapy
questionnaire administrationOther
Ancillary study
management of therapy complicationsOther
Also called complications of therapy, management of
To be determined by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4. Receives: Other: acupuncture therapy; Other: questionnaire administration; Other: management of therapy complications |
| Arm II | Experimental | Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks. Receives: Other: acupuncture therapy; Other: questionnaire administration; Other: management of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Neuropathic Pain Symptom Inventory Scores
Measured: At the end of 4 courses of chemotherapy
Secondary outcomes (5)
Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management
Measured: Eight weeks after study enrollment
Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment
Measured: Eight weeks after study enrollment
Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture
Measured: Eight weeks after study enrollment
Comparison of changes in neurological assessment of patients
Measured: At the end of therapy and 1 month after the end of therapy
Correlation between nerve inventory questionnaires and quantitative nerve tests
Measured: Eight weeks after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Unable to recruit patients in the 6 month extension allowed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry Openshaw, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050075
- Sponsor's protocol ID
- 09109
- Other IDs
- NCI-2010-00103
- Status last verified
- Nov 2017
- First submitted
- 14 Jan 2010
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01050075
- Acronym / sponsor ID
- 09109
- Conditions
- Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Keywords
- male breast cancer, neurotoxicity, recurrent breast cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit patients in the 6 month extension allowed.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy.
PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving paclitaxel.
Detailed description
PRIMARY OBJECTIVE:
- To explore the potential for the use of acupuncture to prevent a worsening of the nerve damage in patients (during treatment) due to paclitaxel as measured by a Neuropathic Pain Symptom Inventory.
SECONDARY OBJECTIVES:
- Evaluate the impact of acupuncture based on neurological assessment, quantitative sensory tests and nerve conduction tests.
II. Evaluate the improvement observed when treating patients for peripheral neuropathy (post-chemotherapy) with acupuncture based on the same metrics.
III. To correlate objective measures of neuropathy (nerve conduction, quantitative sensory tests, neuropathy composite score, and blood cytokine levels) with the subjective questionnaire/quality of life measures.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
ARM II: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Other: acupuncture therapy, Other: questionnaire administration, Other: management of therapy complicationsPatients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4. |
| Arm II | Experimental | Other: acupuncture therapy, Other: questionnaire administration, Other: management of therapy complicationsPatients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have a history of histologically or cytologically confirmed stage I, II, or III breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (CTCAE criteria)
- Performance ECOG 0-2 (Karnofsky Performance Status >= 60%)
- Life expectancy of greater than 6 months
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (7 listed)
- Patients with radiologically confirmed stage IV breast cancer
- Patients who had acupuncture in the previous 8 weeks
- Change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics ("change" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen)
- Patients with needle phobia
- Patients who experienced any peripheral neuropathy prior to chemotherapy
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 therapyAlso: acupunctureacupuncture therapy | Other | Arm I, Arm II |
| questionnaire administrationAncillary study | Other | Arm I, Arm II |
| management of therapy complicationsAlso: complications of therapy, management ofTo be determined by the treating physician | Other | Arm I, Arm II |
Primary outcome
Change in the Neuropathic Pain Symptom Inventory Scores
Time frame: At the end of 4 courses of chemotherapy
5 secondary outcomes
Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management
Time frame: Eight weeks after study enrollment
Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment
Time frame: Eight weeks after study enrollment
Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture
Time frame: Eight weeks after study enrollment
Comparison of changes in neurological assessment of patients
Time frame: At the end of therapy and 1 month after the end of therapy
Correlation between nerve inventory questionnaires and quantitative nerve tests
Time frame: Eight weeks after study enrollment
Results and safety
The study was stopped early (reason given: Unable to recruit patients in the 6 month extension allowed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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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.
Harry Openshaw principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture therapy, questionnaire administration and management of therapy complications in people with Breast Cancer and Stage I Breast Cancer, run by City of Hope Medical Center at 2 sites 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 4 inclusion and 7 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Unable to recruit patients in the 6 month extension allowed.). Results are not available in the source record.
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?
Change in the Neuropathic Pain Symptom Inventory Scores (time frame: At the end of 4 courses of chemotherapy). 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 6 Nov 2017.