Breast CancerNCT01983982
Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms
An observational study of Breast Cancer and Chronic Pain, run by University of Michigan at 1 site in United States.
Trial summary
Many breast cancer survivors report chronic pain that develops or worsens following chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chronic Pain
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 2016
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women initiating adjuvant chemotherapy to treat stage I-III breast cancer.
Who may be able to join
- Female gender
- Histologically proven stage I-III invasive carcinoma of the breast who is planning to receive a standard dose of adjuvant chemotherapy.
- Surgical resection should be complete at the time of study enrollment.
- Eastern Cooperative Oncology Group performance status 0-2.
Who cannot join
- Average pain over the past 24 hours of 4 or greater on a 0-10 scale.
- Peripheral sensory neuropathy grade 2 or higher.
- Personal history of schizophrenia or major depressive disorder, or history of suicidal ideation or attempt within the past 2 years.
- Thumbnail abnormalities on either hand (such as artificial nails) that are likely to alter pain perception during testing.
- Pregnant or nursing.
- No prior chemotherapy for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms in Early Stage Breast Cancer
Many breast cancer survivors report chronic pain that develops or worsens following chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain. We are also investigating whether a patient's sensitivity to pain is related to how many symptoms she experiences during treatment.
- Conditions
- Breast Cancer, Chronic Pain
- Keywords
- Breast Cancer, Chemotherapy, Chronic Pain, Survivorship
- Medical subject headings
- Breast Neoplasms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant chemotherapy | Subjects will undergo pain testing, then receive standard of care chemotherapy, and then undergo pain testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting patients at chemotherapy initiation
Feasibility will be measured by the proportion of women who complete the post-chemotherapy assessment among those consenting to participate in the trial.
Measured: 15 weeks
Secondary outcomes (2)
Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy
Patients will undergo quantitative sensory testing to identify change in pain threshold and in the magnitude of conditioned pain modulation before chemotherapy and shortly after the final dose of chemotherapy.
Measured: 15 weeks
Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain
Exploratory analyses will be conducted to examine associations between either baseline or change in quantitative sensory testing measures and change in patient-reported outcomes.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2016
- Study completionJan 2016
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 University of MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Damon Runyon Cancer Research Foundation
- Responsible party
- Principal investigator, N. Lynn Henry, University of Michigan
- Investigators
- Norah L Henry, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983982
- Sponsor's protocol ID
- HUM00077174
- Other IDs
- UMCC 2013.073
- Status last verified
- Jul 2016
- First submitted
- 7 Nov 2013
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms in Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01983982
- Acronym / sponsor ID
- HUM00077174
- Conditions
- Breast Cancer, Chronic Pain
- Keywords
- Breast Cancer, Chemotherapy, Chronic Pain, Survivorship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Damon Runyon Cancer Research Foundation
- Study start
- Nov 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Nov 2013 (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.
Many breast cancer survivors report chronic pain that develops or worsens following chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain. We are also investigating whether a patient's sensitivity to pain is related to how many symptoms she experiences during treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant chemotherapy | – | –Subjects will undergo pain testing, then receive standard of care chemotherapy, and then undergo pain testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women initiating adjuvant chemotherapy to treat stage I-III breast cancer.
Key inclusion criteria (4 listed)
- Female gender
- Histologically proven stage I-III invasive carcinoma of the breast who is planning to receive a standard dose of adjuvant chemotherapy.
- Surgical resection should be complete at the time of study enrollment.
- Eastern Cooperative Oncology Group performance status 0-2.
Key exclusion criteria (6 listed)
- Average pain over the past 24 hours of 4 or greater on a 0-10 scale.
- Peripheral sensory neuropathy grade 2 or higher.
- Personal history of schizophrenia or major depressive disorder, or history of suicidal ideation or attempt within the past 2 years.
- Thumbnail abnormalities on either hand (such as artificial nails) that are likely to alter pain perception during testing.
- Pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of recruiting patients at chemotherapy initiation
Time frame: 15 weeks
Feasibility will be measured by the proportion of women who complete the post-chemotherapy assessment among those consenting to participate in the trial.
2 secondary outcomes
Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy
Time frame: 15 weeks
Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
Norah L Henry, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Chronic Pain, run by University of Michigan 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of recruiting patients at chemotherapy initiation (time frame: 15 weeks). 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 26 Jul 2016.