Breast CancerNCT01016028
Chemotherapy-Induced Peripheral Neuropathy Survey
An observational study of Breast Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this research study is to learn more about pain and other symptoms that patients may experience while receiving chemotherapy treatment with platinum agents, taxanes, and/or bortezomib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Myeloma
- What is being tested?
- Questionnaire, Sensory Tests and Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Feb 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, age 18 years or older, receiving chemotherapy with cisplatin or oxaliplatin (platinum agents), taxanes, and/or bortezomib at UT MD Anderson Cancer Center.
Who may be able to join
- Patients >= 18 years old.
- Patients must be fluent with the English language.
- Patients must be on chemotherapy regimes with any of the study drugs: cisplatin, oxaliplatin, taxanes and/or bortezomib.
Who cannot join
- Significant cognitive impairment as determined by the trained research staff
- Chronic alcoholism or substance abuse
- Diagnosis of severe depression
About this study
Official title: Chemotherapy-Induced Peripheral Neuropathy: Feasibility and Validity of New Symptom Measurement Tools in Patients on Treatment With Platinum Agents, Taxanes and Bortezomib
The goal of this research study is to learn more about pain and other symptoms that patients may experience while receiving chemotherapy treatment with platinum agents, taxanes, and/or bortezomib.
Read the detailed description
If patient agrees to take part in this study, they will be asked to complete 3 questionnaires, 3 sensory tests, and may be asked to take part in a one-on-one symptom interview.
Symptom Interview:
Depending on when patient is enrolled in this study, they may take part in a one-on-one interview with a study staff member. A total of 15 participants will take part in this interview (5 taking platinum agents, 5 taking taxanes, \& 5 taking bortezomib). During the interview, patient will be asked to describe their symptoms. The interview should take about 20-30 minutes to complete.
The interviews will be digitally recorded, transcribed (typed), and used by researchers to identify symptoms related to receiving this type of chemotherapy. Researchers will use this information to design a study questionnaire that focuses on chemotherapy symptoms in the hands and feet. The digital recordings and typed copies of the interview will be destroyed after researchers have analyzed the interview data and the study is complete.
Questionnaires \& Sensory Tests:
All study participants will complete 3 questionnaires that are designed to collect information about any pain and/or symptoms patient may have experienced, their general well-being, and personal information such as age and marital status. One (1) of them is called a symptom assessment questionnaire and patient be will asked to rate their symptoms on a scale of 0-10.
All study participants will also complete 3 tests, called sensory tests, that are designed to help researchers learn how sensitive patient is to things such as cold and touch. These tests involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board. Patient will also be asked to mark on computerized drawings the areas where they experience any pain, numbness, and/or cold sensitivity. A study staff member will explain how to take the tests and use the computerized drawings in more detail at the time these tests are performed.
It should take about 20-30 minutes to complete all of the questionnaires and tests.
Additional Sensory Testing:
Out of the 200 participants on this study, 40 participants will be asked to return to the clinic for additional sensory testing to help researchers learn if the tools used for this study are working as expected.
This additional testing is designed to help researchers learn how sensitive patient is to things such as touch, cold, warmth, and a pinprick to the finger, hand, or arm. Patient will be asked to describe how well they can feel each test, and how much pain they may or may not feel. This additional testing should take about 60 minutes to complete.
Length of Study:
After patient has completed the interview (if they are asked), 3 questionnaires, and 3 sensory tests their participation on this study will be over. If patient is selected to take part in the additional sensory testing, their participation on this study will be over after those tests are complete.
This is an investigational study.
Up to 200 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Questionnaire, Sensory Tests, Interview
- Keywords
- Cancer, Colorectum Cancer, Colorectal disease, neuropathic symptom tool, chemotherapy-induced peripheral neuropathy, CIPN, Pain, Quantitative Sensory Testing, QST, symptom measurement tools, platinum agents, cisplatin, oxaliplatin, taxanes, bortezomib
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Neoplasms, Plasma Cell, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
3 questionnaires to collect information about any pain and/or symptoms experienced, general well-being, and personal information such as age and marital status. One (1) will be a symptom assessment questionnaire where asked to rate symptoms on a scale of 0-10.
Sensory TestsBehavioural
Test of sensitivity to things such as cold and touch, involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board; and marking on computerized drawings areas experience pain, numbness, and/or cold sensitivity.
InterviewBehavioural
First 5 patients receiving platinum agents, taxanes, and bortezomib (15 patients total) will be asked to describe their symptoms in an open-ended, semi-structured 20-30 minute interview.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire + Sensory Tests + Interview | Not described Receives: Behavioral: Questionnaire; Behavioral: Sensory Tests; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Patient's Symptoms (Questionnaire)
Measured: Each patient administered questionnaire at single point in time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Study assessment tool development delayed.
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 M.D. Anderson Cancer 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Cleeland, PHD,BA, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016028
- Sponsor's protocol ID
- 2009-0439
- Status last verified
- Feb 2013
- First submitted
- 17 Nov 2009
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-Induced Peripheral Neuropathy: Feasibility and Validity of New Symptom Measurement Tools in Patients on Treatment With Platinum Agents, Taxanes and Bortezomib
- ClinicalTrials.gov ID
- NCT01016028
- Acronym / sponsor ID
- 2009-0439
- Keywords
- Cancer, Colorectum Cancer, Colorectal disease, neuropathic symptom tool, chemotherapy-induced peripheral neuropathy, CIPN, Pain, Quantitative Sensory Testing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study assessment tool development delayed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Nov 2009 (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.
The goal of this research study is to learn more about pain and other symptoms that patients may experience while receiving chemotherapy treatment with platinum agents, taxanes, and/or bortezomib.
Detailed description
If patient agrees to take part in this study, they will be asked to complete 3 questionnaires, 3 sensory tests, and may be asked to take part in a one-on-one symptom interview.
Symptom Interview:
Depending on when patient is enrolled in this study, they may take part in a one-on-one interview with a study staff member. A total of 15 participants will take part in this interview (5 taking platinum agents, 5 taking taxanes, \& 5 taking bortezomib). During the interview, patient will be asked to describe their symptoms. The interview should take about 20-30 minutes to complete.
The interviews will be digitally recorded, transcribed (typed), and used by researchers to identify symptoms related to receiving this type of chemotherapy. Researchers will use this information to design a study questionnaire that focuses on chemotherapy symptoms in the hands and feet. The digital recordings and typed copies of the interview will be destroyed after researchers have analyzed the interview data and the study is complete.
Questionnaires \& Sensory Tests:
All study participants will complete 3 questionnaires that are designed to collect information about any pain and/or symptoms patient may have experienced, their general well-being, and personal information such as age and marital status. One (1) of them is called a symptom assessment questionnaire and patient be will asked to rate their symptoms on a scale of 0-10.
All study participants will also complete 3 tests, called sensory tests, that are designed to help researchers learn how sensitive patient is to things such as cold and touch. These tests involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board. Patient will also be asked to mark on computerized drawings the areas where they experience any pain, numbness, and/or cold sensitivity. A study staff member will explain how to take the tests and use the computerized drawings in more detail at the time these tests are performed.
It should take about 20-30 minutes to complete all of the questionnaires and tests.
Additional Sensory Testing:
Out of the 200 participants on this study, 40 participants will be asked to return to the clinic for additional sensory testing to help researchers learn if the tools used for this study are working as expected.
This additional testing is designed to help researchers learn how sensitive patient is to things such as touch, cold, warmth, and a pinprick to the finger, hand, or arm. Patient will be asked to describe how well they can feel each test, and how much pain they may or may not feel. This additional testing should take about 60 minutes to complete.
Length of Study:
After patient has completed the interview (if they are asked), 3 questionnaires, and 3 sensory tests their participation on this study will be over. If patient is selected to take part in the additional sensory testing, their participation on this study will be over after those tests are complete.
This is an investigational study.
Up to 200 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire + Sensory Tests + Interview | – | Behavioral: Questionnaire, Behavioral: Sensory Tests, Behavioral: Interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, age 18 years or older, receiving chemotherapy with cisplatin or oxaliplatin (platinum agents), taxanes, and/or bortezomib at UT MD Anderson Cancer Center.
Key inclusion criteria (3 listed)
- Patients >= 18 years old.
- Patients must be fluent with the English language.
- Patients must be on chemotherapy regimes with any of the study drugs: cisplatin, oxaliplatin, taxanes and/or bortezomib.
Key exclusion criteria (3 listed)
- Significant cognitive impairment as determined by the trained research staff
- Chronic alcoholism or substance abuse
- Diagnosis of severe depression
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 |
|---|---|---|
| QuestionnaireAlso: Survey3 questionnaires to collect information about any pain and/or symptoms experienced, general well-being, and personal information such as age and marital status. One (1) will be a symptom assessment questionnaire where asked to rate symptoms on a scale of 0-10. | Behavioural | Questionnaire + Sensory Tests + Interview |
| Sensory TestsTest of sensitivity to things such as cold and touch, involve feeling cold objects, feeling bumps on a rectangular board, and putting pegs into holes on a board; and marking on computerized drawings areas experience pain, numbness, and/or cold sensitivity. | Behavioural | Questionnaire + Sensory Tests + Interview |
| InterviewFirst 5 patients receiving platinum agents, taxanes, and bortezomib (15 patients total) will be asked to describe their symptoms in an open-ended, semi-structured 20-30 minute interview. | Behavioural | Questionnaire + Sensory Tests + Interview |
Primary outcome
Assessment of Patient's Symptoms (Questionnaire)
Time frame: Each patient administered questionnaire at single point in time.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Charles Cleeland, PHD,BA principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Assessment of Patient's Symptoms (Questionnaire) (time frame: Each patient administered questionnaire at single point in time.). 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 3 May 2016.