Breast CancerNCT01153282
Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
An observational study of Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to May 2012
- 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 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The semi-structured interviews will be conducted with breast cancer patients of the Rena Rowan Breast Center of the Abramson Cancer Center of the University of Pennsylvania. A purposive sampling strategy in which study participants are recruited based on a particular characteristic of experience of interest, will be used to select breast cancer patients (N=30). Participants will be recruitedwith the goal of having a balanced sample of women who experience documented CIPN (per Common Toxicity Criteria for Adverse Events CTCAE - grading criteria, details below) and those who received a taxane but did not have documented CIPN.
Who may be able to join
- Women 21-70 years old (Women over 70 are offered chemotherapy less frequently because of their risk benefit ratio. Including them would be a selection bias because of their differential underexposure).
- Initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously untreated metastatic setting.
- The range of exposure to taxane-based chemotherapy will include women on active treatment having received two cycles, to women who are within three months of their last infusion.
- Documented symptoms of CIPN per CTCAE grading criteria (half of sample) or NO symptoms (half of sample) Grade 0 = no CIPN symptoms Grade 1 = mild symptoms Grade 2 = moderate symptoms - prescribed Gabapentin (Neurontin) Grade 3\&4= severe symptoms - treated with Gabapentin (Neurontin), treatment plan altered
Who cannot join
- Physical disabilities - defined by use of assistive devices to complete functional tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy.
- Current exposure to neurotoxic agents (Navelbine, platinums or other taxanes)
- Pregnancy during chemotherapy treatment
- Diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically established neuropathy
- Previous exposure to chemotherapy or radiotherapy
- HIV positive (high risk for neuropathy)
- Other neurological diseases, such as Multiple Sclerosis
- Other pre-existing neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy.
Read the detailed description
Taxanes, a type of chemotherapeutic agent prescribed to breast cancer patients, have a known physical side effect of chemotherapy induced peripheral neuropathy (CIPN). The purpose of this qualitative study is to understand the experience and physical functional side effects of taxanes. This is the first of a two phase study. The overall goal is to identify existing objective physical performance measures to assess functional side effects of taxanes.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer patients
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of interviews
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionMay 2012
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 Abramson Cancer Center at Penn MedicineThe 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
- Other
- Time perspective
- Other
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela DeMichele, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153282
- Sponsor's protocol ID
- UPCC 14110
- Status last verified
- Mar 2020
- First submitted
- 28 Jun 2010
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT01153282
- Acronym / sponsor ID
- UPCC 14110
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Jun 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.
Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy.
Detailed description
Taxanes, a type of chemotherapeutic agent prescribed to breast cancer patients, have a known physical side effect of chemotherapy induced peripheral neuropathy (CIPN). The purpose of this qualitative study is to understand the experience and physical functional side effects of taxanes. This is the first of a two phase study. The overall goal is to identify existing objective physical performance measures to assess functional side effects of taxanes.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The semi-structured interviews will be conducted with breast cancer patients of the Rena Rowan Breast Center of the Abramson Cancer Center of the University of Pennsylvania. A purposive sampling strategy in which study participants are recruited based on a particular characteristic of experience of interest, will be used to select breast cancer patients (N=30). Participants will be recruitedwith the goal of having a balanced sample of women who experience documented CIPN (per Common Toxicity Criteria for Adverse Events CTCAE - grading criteria, details below) and those who received a taxane but did not have documented CIPN.
Key inclusion criteria (4 listed)
- Women 21-70 years old (Women over 70 are offered chemotherapy less frequently because of their risk benefit ratio. Including them would be a selection bias because of their differential underexposure).
- Initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously untreated metastatic setting.
- The range of exposure to taxane-based chemotherapy will include women on active treatment having received two cycles, to women who are within three months of their last infusion.
- Documented symptoms of CIPN per CTCAE grading criteria (half of sample) or NO symptoms (half of sample) Grade 0 = no CIPN symptoms Grade 1 = mild symptoms Grade 2 = moderate symptoms - prescribed Gabapentin (Neurontin) Grade 3\&4= severe symptoms - treated with Gabapentin (Neurontin), treatment plan altered
Key exclusion criteria (8 listed)
- Physical disabilities - defined by use of assistive devices to complete functional tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy.
- Current exposure to neurotoxic agents (Navelbine, platinums or other taxanes)
- Pregnancy during chemotherapy treatment
- Diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically established neuropathy
- Previous exposure to chemotherapy or radiotherapy
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
Number of interviews
Time frame: 2 years
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 10 Mar 2020.
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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.
Angela DeMichele, MD principal investigator
Abramson Cancer Center at Penn Medicine
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, run by Abramson Cancer Center at Penn Medicine 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 8 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 10 Mar 2020. 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?
Number of interviews (time frame: 2 years). 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 10 Mar 2020.