Breast CancerNCT00738998
Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer Patients Receiving Aromatase Inhibitors
A study testing Questionnaire and Phone Calls in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn more about what it is like for patients with breast cancer to receive treatment with the drug anastrozole. Researchers want to learn about possible symptoms, such as joint pain, that patients may experience during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaire and Phone Calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2008to 28 Jun 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with early stage hormone receptor positive breast cancer who are at these 2 time points in their anastrozole treatment: 1) at the time period between two months prior or one month after beginning of their anastrozole treatment (Cohort 1); 2) patients within +/- 2 months of the beginning of the third year of anastrozole treatment (Cohort 2).
- Patients >= 18 years old.
Who cannot join
- Patients with metastatic disease.
- Patients who cannot complete the assessment tools.
- Patients without telephone access.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to learn more about what it is like for patients with breast cancer to receive treatment with the drug anastrozole. Researchers want to learn about possible symptoms, such as joint pain, that patients may experience during treatment. Researchers also want to learn more about which patients are most likely to have joint symptoms by looking at certain proteins from routine blood draw samples.
Read the detailed description
Study Groups:
If you agree to take part in this study, you will be assigned to one of two groups, depending on how long you have been receiving anastrozole treatment. If you are within two months prior to or one month after starting treatment, you will be assigned to Group 1 and you will be followed through 2 years of treatment. If you have been taking anastrozole for about 2 years, you will be assigned to Group 2 and you will be followed through your third year of treatment.
Study Procedures:
You will complete tests and procedures during your regularly scheduled clinic visits.
Assessment 1:
- You will be taught how to use an automated symptom assessment program. For this program, a telephone system will call you at your home at a time that is convenient for you. Using the numeric key pad on your telephone, you will rate your pain and how it interferes with your daily activities.
- You will complete questionnaires about your pain and other symptoms, quality of life, and your ability to work. Completing the questionnaires should take about 45 minutes.
- You will also complete some cognitive (mental) questionnaires that should take about 30 minutes to complete. The cognitive questionnaires will be given to learn about problems with attention or mental fatigue that may be related to your treatment. If you choose not to complete the cognitive questionnaires, you can still participate in this study.
- Blood (about 2 ½ tablespoons) will be drawn to learn about how certain proteins called cytokines (found in the blood) change during therapy. Researchers will also measure the C-reactive protein (CRP) which indicates whether there is inflammation in your body.
- You will have an exam of your bone joints and you will be shown how to perform a self-exam on your joints at home using a study joint pain kit. This kit will be mailed to you if you have a new joint pain.
- Demographic information (name, address, date of birth, weight, height, marital status, job status, education, medical insurance status, and race) will be collected.
- Participants in Group 2 will complete a medication adherence questionnaire. This questionnaire contains questions about the dose of anastrozole you are taking, if it has changed (increased or decreased), and if you have been given any drugs to help manage symptoms that you may be experiencing. This form should take about 5 minutes to complete.
- If your doctor in the breast clinic thinks you need to see a specialist because of the pain or swelling you are experiencing, you will be referred to a rheumatologist here at MD Anderson. The rheumatologist will perform a bone joint examination and may order a blood draw to test for inflammation in your body.
Telephone System Calls:
The telephone system will call you every 2 weeks at a time convenient to you so that you can rate your pain and how it interferes with your daily activities. Each phone call will take about 5 minutes to complete.
While you are on the study, if you report through the telephone system joint pain of a certain level of severity, a joint pain kit will be mailed to you along with a pre-addressed stamped envelope. Study staff will call you to let you know the kit is being mailed and that they can help you complete it, if needed. You will be asked to perform a self exam of your joints and to mark the area that is painful to you on the body drawing included in the kit. You will also answer some questions about your pain and about your medication and supplement use. You will be asked to return the completed kit to the project office in the pre-addressed stamped envelope included with the kit. This kit should be able to be completed in about 15 minutes.
Every Month:
The study coordinator will call you monthly at a time convenient to you so that you can rate your symptoms and how they interfere with your daily activities.
Every 4 - 6 Months:
Research staff will arrange to meet you at your regularly scheduled clinic visits. These visits will take about 45 minutes. At these visits, you will have the following exams:
- Demographic information (marital status, job status, education, weight, and medical insurance status will again be collected.
- Blood (about 2 ½ tablespoons) will be drawn for cytokines and CRP testing.
- You will be asked to complete some questionnaires about your symptoms, ability to work, and quality of life.
- All participants will repeat the medication adherence questionnaire.
- A brief exam of your bone joints will be performed by the research staff.
- You will be asked to tell researchers about any changes in the medications, both prescribed and over the counter, and supplements you may be taking.
Annual Visits:
At your regularly scheduled annual visit (up to 2 times while on study), you will complete the following tests:
-If you agreed at the beginning of the study, you will complete the cognitive questionnaires. This should take about 45 minutes to complete.
The entire study-related time you will spend at your annual visit will be about 1 hour and 30 minutes.
Research staff will also collect clinical information and test results from your medical record while you are on study.
Length of Study:
Participants in Group 1 will remain on the study for up to 2 years. Participants in Group 2 will remain on the study for 12-14 months, depending on how follow-up clinic visits are scheduled.
This is an investigational study. Up to 102 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Questionnaire, Phone Calls
- Keywords
- Breast Cancer, Aromatase Inhibitors, Symptom Assessment, Questionnaire, Survey, Phone Call, Arimidex, Anastrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires about pain and other symptoms, quality of life, and ability to work will be completed.
Phone CallsOther
A telephone system will call every 2 weeks so that you can rate your symptoms and how they interfere with daily activities. Each call will take about 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire and Telephone Assessments | Experimental | Breast cancer patients assigned to one or two groups: Group 1) enrolled at beginning of anastrozole treatment; or Group 2) if beginning third year of anastrozole treatment. Receives: Behavioral: Questionnaire; Other: Phone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, onset and severity of arthralgia during anastrozole treatment
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study start5 Jun 2008
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Why it stopped: Requested by PI
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Charles Cleeland, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738998
- Sponsor's protocol ID
- 2006-1038
- Status last verified
- Dec 2019
- First submitted
- 13 Aug 2008
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Arthralgia and Related Symptoms in Breast Cancer Patients Receiving Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT00738998
- Acronym / sponsor ID
- 2006-1038
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Aromatase Inhibitors, Symptom Assessment, Questionnaire, Survey, Phone Call, Arimidex, Anastrozole
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Requested by PI
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 5 Jun 2008 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 21 Aug 2008 (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 what it is like for patients with breast cancer to receive treatment with the drug anastrozole. Researchers want to learn about possible symptoms, such as joint pain, that patients may experience during treatment. Researchers also want to learn more about which patients are most likely to have joint symptoms by looking at certain proteins from routine blood draw samples.
Detailed description
Study Groups:
If you agree to take part in this study, you will be assigned to one of two groups, depending on how long you have been receiving anastrozole treatment. If you are within two months prior to or one month after starting treatment, you will be assigned to Group 1 and you will be followed through 2 years of treatment. If you have been taking anastrozole for about 2 years, you will be assigned to Group 2 and you will be followed through your third year of treatment.
Study Procedures:
You will complete tests and procedures during your regularly scheduled clinic visits.
Assessment 1:
- You will be taught how to use an automated symptom assessment program. For this program, a telephone system will call you at your home at a time that is convenient for you. Using the numeric key pad on your telephone, you will rate your pain and how it interferes with your daily activities.
- You will complete questionnaires about your pain and other symptoms, quality of life, and your ability to work. Completing the questionnaires should take about 45 minutes.
- You will also complete some cognitive (mental) questionnaires that should take about 30 minutes to complete. The cognitive questionnaires will be given to learn about problems with attention or mental fatigue that may be related to your treatment. If you choose not to complete the cognitive questionnaires, you can still participate in this study.
- Blood (about 2 ½ tablespoons) will be drawn to learn about how certain proteins called cytokines (found in the blood) change during therapy. Researchers will also measure the C-reactive protein (CRP) which indicates whether there is inflammation in your body.
- You will have an exam of your bone joints and you will be shown how to perform a self-exam on your joints at home using a study joint pain kit. This kit will be mailed to you if you have a new joint pain.
- Demographic information (name, address, date of birth, weight, height, marital status, job status, education, medical insurance status, and race) will be collected.
- Participants in Group 2 will complete a medication adherence questionnaire. This questionnaire contains questions about the dose of anastrozole you are taking, if it has changed (increased or decreased), and if you have been given any drugs to help manage symptoms that you may be experiencing. This form should take about 5 minutes to complete.
- If your doctor in the breast clinic thinks you need to see a specialist because of the pain or swelling you are experiencing, you will be referred to a rheumatologist here at MD Anderson. The rheumatologist will perform a bone joint examination and may order a blood draw to test for inflammation in your body.
Telephone System Calls:
The telephone system will call you every 2 weeks at a time convenient to you so that you can rate your pain and how it interferes with your daily activities. Each phone call will take about 5 minutes to complete.
While you are on the study, if you report through the telephone system joint pain of a certain level of severity, a joint pain kit will be mailed to you along with a pre-addressed stamped envelope. Study staff will call you to let you know the kit is being mailed and that they can help you complete it, if needed. You will be asked to perform a self exam of your joints and to mark the area that is painful to you on the body drawing included in the kit. You will also answer some questions about your pain and about your medication and supplement use. You will be asked to return the completed kit to the project office in the pre-addressed stamped envelope included with the kit. This kit should be able to be completed in about 15 minutes.
Every Month:
The study coordinator will call you monthly at a time convenient to you so that you can rate your symptoms and how they interfere with your daily activities.
Every 4 - 6 Months:
Research staff will arrange to meet you at your regularly scheduled clinic visits. These visits will take about 45 minutes. At these visits, you will have the following exams:
- Demographic information (marital status, job status, education, weight, and medical insurance status will again be collected.
- Blood (about 2 ½ tablespoons) will be drawn for cytokines and CRP testing.
- You will be asked to complete some questionnaires about your symptoms, ability to work, and quality of life.
- All participants will repeat the medication adherence questionnaire.
- A brief exam of your bone joints will be performed by the research staff.
- You will be asked to tell researchers about any changes in the medications, both prescribed and over the counter, and supplements you may be taking.
Annual Visits:
At your regularly scheduled annual visit (up to 2 times while on study), you will complete the following tests:
-If you agreed at the beginning of the study, you will complete the cognitive questionnaires. This should take about 45 minutes to complete.
The entire study-related time you will spend at your annual visit will be about 1 hour and 30 minutes.
Research staff will also collect clinical information and test results from your medical record while you are on study.
Length of Study:
Participants in Group 1 will remain on the study for up to 2 years. Participants in Group 2 will remain on the study for 12-14 months, depending on how follow-up clinic visits are scheduled.
This is an investigational study. Up to 102 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire and Telephone Assessments | Experimental | Behavioral: Questionnaire, Other: Phone CallsBreast cancer patients assigned to one or two groups: Group 1) enrolled at beginning of anastrozole treatment; or Group 2) if beginning third year of anastrozole treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with early stage hormone receptor positive breast cancer who are at these 2 time points in their anastrozole treatment: 1) at the time period between two months prior or one month after beginning of their anastrozole treatment (Cohort 1); 2) patients within +/- 2 months of the beginning of the third year of anastrozole treatment (Cohort 2).
- Patients >= 18 years old.
Key exclusion criteria (3 listed)
- Patients with metastatic disease.
- Patients who cannot complete the assessment tools.
- Patients without telephone access.
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: SurveyQuestionnaires about pain and other symptoms, quality of life, and ability to work will be completed. | Behavioural | Questionnaire and Telephone Assessments |
| Phone CallsA telephone system will call every 2 weeks so that you can rate your symptoms and how they interfere with daily activities. Each call will take about 5 minutes. | Other | Questionnaire and Telephone Assessments |
Primary outcome
Incidence, onset and severity of arthralgia during anastrozole treatment
Time frame: 3 Years
Results and safety
The study was stopped early (reason given: Requested by PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- 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 principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and Phone Calls in people with Breast Cancer, run by M.D. Anderson Cancer Center 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 2 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: stopped early, as of the sponsor's last update on 2 Jan 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 was stopped early (reason given: Requested by PI). 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?
Incidence, onset and severity of arthralgia during anastrozole treatment (time frame: 3 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 2 Jan 2020.