Breast CancerNCT01272570
Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors
An observational study of Breast Cancer and Xerostomia, run by University of Michigan at 1 site in United States.
Trial summary
The 3 Specific Aims are (1) To determine the prevalence, incidence and severity of oral conditions in postmenopausal early stage breast cancer survivors within the first 18 months of adjuvant Aromatase Inhibitor(AI) therapy, (2) To determine the oral health quality of life among postmenopausal early stage breast… Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Xerostomia
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 29 postmenopausal women with a history of early stage BCa receiving adjuvant AI therapy and 29 postmenopausal women without cancer
Who may be able to join
- Postmenopausal as defined by NCCN (any of the following)
- Prior bilateral oophorectomy
- Age equal to or greater then 60 years of age
- Age less then 60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression and FSH and estradiol in the postmenopausal range
- If taking tamoxifen or toremifene and age less then 60y, then FSH and plasma estradiol level in postmenopausal ranges71.
- Individuals capable of consenting and self administering the survey instrument.
Show all 12Show fewer
- At least 15 teeth present.
- AI users:
- Diagnosis of BCa- Histologic confirmed diagnosis of BCa: Stage 0, I, II, or III with no evidence of metastatic disease.
- Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole). Subjects may have had prior tamoxifen or raloxifene. Subjects may have had chemotherapy and/or radiation therapy. Must be within the first year of consecutive AI therapy. If a subject started AI, discontinued, then restarted, they will be accepted into the study as long as the past therapy did not exceed 12 months and the current therapy has not exceeded 12 months.
- Controls:
- -No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of thyroid or skin cancer).
Who cannot join
- Metastatic BCa (AI treated group: fully resected locally recurrent disease is permitted if the patient has been rendered without evidence of disease).
- Significant psychiatric illness/social situations that would preclude completion of questionnaires
- Chronic medications known to affect the periodontal status (calcium antagonist, anti-convulsives, immunosuppressives (> prednisone 7.5mg daily). NSAIDS and bisphosphonates are permitted.
- Premedication- Conditions that require antibiotic therapy will be evaluated on a case-by-case basis. (Patients taking prophylaxis for joint replacements will not be excluded.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
Official title: Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors: The Role of Aromatase Inhibitors
The 3 Specific Aims are (1) To determine the prevalence, incidence and severity of oral conditions in postmenopausal early stage breast cancer survivors within the first 18 months of adjuvant Aromatase Inhibitor(AI) therapy, (2) To determine the oral health quality of life among postmenopausal early stage breast cancer survivors who are receiving AI therapy, (3) To determine the utilization of dental care among postmenopausal women receiving AIs with a history of early stage BCa over time. The hypothesis for this pilot study is that AIs negatively impact oral health and oral health quality of life in the setting of breast cancer survivors. Further, we hypothesize that dental visits are underutilized in women with BCa undergoing adjuvant AI therapy.
Read the detailed description
This is a 2 arm prospective study. PM women receiving breast care, with and without breast cancer, at the University of Michigan are eligible. The study procedures include: survey/questionnaires, oral exam performed at Michigan Center for Oral Health Research (MCOHR) with specimen collection, and medical chart review. The goal of this study is to collect dental data and oral health quality of life data on women who are receiving AI therapy. This study does not administer any treatments or drugs to participants.
- Conditions
- Breast Cancer, Xerostomia
- Keywords
- breast, oral, cancer
- Medical subject headings
- Breast Neoplasms, Xerostomia, Neoplasms
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 |
|---|---|---|
| Aromatase Inhibitor | * Diagnosis of BCa- Histologic confirmed diagnosis of BCa: Stage 0, I, II, or III with no evidence of metastatic disease. * Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole). Subjects may have had prior tamoxifen or raloxifene. Subjects may have had chemotherapy and/or radiation therapy. Must be within the first year of consecutive AI therapy. If a subject started AI, discontinued, then restarted, they will be accepted into the study as long as the past therapy did not exceed 12 months and the current therapy has not exceeded 12 months. | |
| Control | • No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of thyroid or skin cancer). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal diseases
Measured: At the time of study visit
Secondary outcomes (1)
Oral health quality of life
Measured: At the time of study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Susan Taichman, University of Michigan
- Investigators
- Linda (Susan) Taichman, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272570
- Sponsor's protocol ID
- HUM00036200
- Status last verified
- May 2015
- First submitted
- 6 Jan 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ries LA YJ, Keel GE, Eisner MP, Lin YD, Horner MJ. SEER Survival Monograph: Cancer Survival Among Adults: U.S. SEER Program, 1988-2001, Patient and Tumor Characteristics. . , Bethesda, MD,: National Cancer Institute, SEER Program, ; 2007.
Sonis ST, Fey EG. Oral complications of cancer therapy. Oncology (Williston Park). 2002 May;16(5):680-6; discussion 686, 691-2, 695.
PubMed 12108892Stokman MA, Sonis ST, Dijkstra PU, Burgerhof JG, Spijkervet FK. Assessment of oral mucositis in clinical trials: impact of training on evaluators in a multi-centre trial. Eur J Cancer. 2005 Aug;41(12):1735-8. doi: 10.1016/j.ejca.2005.04.030.
PubMed 16039109Ohrn KE, Wahlin YB, Sjoden PO. Oral status during radiotherapy and chemotherapy: a descriptive study of patient experiences and the occurrence of oral complications. Support Care Cancer. 2001 Jun;9(4):247-57. doi: 10.1007/s005200000214.
PubMed 11430420Anderson WF, Chatterjee N, Ershler WB, Brawley OW. Estrogen receptor breast cancer phenotypes in the Surveillance, Epidemiology, and End Results database. Breast Cancer Res Treat. 2002 Nov;76(1):27-36. doi: 10.1023/a:1020299707510.
PubMed 12408373Taichman LS, Van Poznak CH, Inglehart MR. Self-reported oral health and quality of life of postmenopausal breast cancer survivors on aromatase inhibitors and women without cancer diagnoses: a longitudinal analysis. Support Care Cancer. 2016 Nov;24(11):4815-24. doi: 10.1007/s00520-016-3336-6. Epub 2016 Jul 25.
PubMed 27455851
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors: The Role of Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT01272570
- Acronym / sponsor ID
- HUM00036200
- Conditions
- Breast Cancer, Xerostomia
- Keywords
- breast, oral, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Jan 2011 (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 3 Specific Aims are (1) To determine the prevalence, incidence and severity of oral conditions in postmenopausal early stage breast cancer survivors within the first 18 months of adjuvant Aromatase Inhibitor(AI) therapy, (2) To determine the oral health quality of life among postmenopausal early stage breast cancer survivors who are receiving AI therapy, (3) To determine the utilization of dental care among postmenopausal women receiving AIs with a history of early stage BCa over time. The hypothesis for this pilot study is that AIs negatively impact oral health and oral health quality of life in the setting of breast cancer survivors. Further, we hypothesize that dental visits are underutilized in women with BCa undergoing adjuvant AI therapy.
Detailed description
This is a 2 arm prospective study. PM women receiving breast care, with and without breast cancer, at the University of Michigan are eligible. The study procedures include: survey/questionnaires, oral exam performed at Michigan Center for Oral Health Research (MCOHR) with specimen collection, and medical chart review. The goal of this study is to collect dental data and oral health quality of life data on women who are receiving AI therapy. This study does not administer any treatments or drugs to participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatase Inhibitor | – | –* Diagnosis of BCa- Histologic confirmed diagnosis of BCa: Stage 0, I, II, or III with no evidence of metastatic disease. * Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole). Subjects may have had prior tamoxifen or raloxifene. Subjects may have had chemotherapy and/or radiation therapy. Must be within the first year of consecutive AI therapy. If a subject started AI, discontinued, then restarted, they will be accepted into the study as long as the past therapy did not exceed 12 months and the current therapy has not exceeded 12 months. |
| Control | – | –• No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of thyroid or skin cancer). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 29 postmenopausal women with a history of early stage BCa receiving adjuvant AI therapy and 29 postmenopausal women without cancer
Key inclusion criteria (12 listed)
- Postmenopausal as defined by NCCN (any of the following)
- Individuals capable of consenting and self administering the survey instrument.
- At least 15 teeth present.
- Diagnosis of BCa- Histologic confirmed diagnosis of BCa: Stage 0, I, II, or III with no evidence of metastatic disease.
- Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole). Subjects may have had prior tamoxifen or raloxifene. Subjects may have had chemotherapy and/or radiation therapy. Must be within the first year of consecutive AI therapy. If a subject started AI, discontinued, then restarted, they will be accepted into the study as long as the past therapy did not exceed 12 months and the current therapy has not exceeded 12 months.
Key exclusion criteria (4 listed)
- Metastatic BCa (AI treated group: fully resected locally recurrent disease is permitted if the patient has been rendered without evidence of disease).
- Significant psychiatric illness/social situations that would preclude completion of questionnaires
- Chronic medications known to affect the periodontal status (calcium antagonist, anti-convulsives, immunosuppressives (> prednisone 7.5mg daily). NSAIDS and bisphosphonates are permitted.
- Premedication- Conditions that require antibiotic therapy will be evaluated on a case-by-case basis. (Patients taking prophylaxis for joint replacements will not be excluded.)
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
Periodontal diseases
Time frame: At the time of study visit
1 secondary outcome
Oral health quality of life
Time frame: At the time of study visit
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 27 May 2015.
- BackgroundRies LA YJ, Keel GE, Eisner MP, Lin YD, Horner MJ. SEER Survival Monograph: Cancer Survival Among Adults: U.S. SEER Program, 1988-2001, Patient and Tumor Characteristics. . , Bethesda, MD,: National Cancer Institute, SEER Program, ; 2007.
- Background: PubMed 12108892Sonis ST, Fey EG. Oral complications of cancer therapy. Oncology (Williston Park). 2002 May;16(5):680-6; discussion 686, 691-2, 695.
- Background: PubMed 16039109Stokman MA, Sonis ST, Dijkstra PU, Burgerhof JG, Spijkervet FK. Assessment of oral mucositis in clinical trials: impact of training on evaluators in a multi-centre trial. Eur J Cancer. 2005 Aug;41(12):1735-8. doi: 10.1016/j.ejca.2005.04.030.
- Background: PubMed 11430420Ohrn KE, Wahlin YB, Sjoden PO. Oral status during radiotherapy and chemotherapy: a descriptive study of patient experiences and the occurrence of oral complications. Support Care Cancer. 2001 Jun;9(4):247-57. doi: 10.1007/s005200000214.
- Background: PubMed 12408373Anderson WF, Chatterjee N, Ershler WB, Brawley OW. Estrogen receptor breast cancer phenotypes in the Surveillance, Epidemiology, and End Results database. Breast Cancer Res Treat. 2002 Nov;76(1):27-36. doi: 10.1023/a:1020299707510.
- Derived from this study: PubMed 27455851Taichman LS, Van Poznak CH, Inglehart MR. Self-reported oral health and quality of life of postmenopausal breast cancer survivors on aromatase inhibitors and women without cancer diagnoses: a longitudinal analysis. Support Care Cancer. 2016 Nov;24(11):4815-24. doi: 10.1007/s00520-016-3336-6. Epub 2016 Jul 25.
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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.
Linda (Susan) Taichman, 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 Xerostomia, 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 12 inclusion and 4 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 27 May 2015. 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?
Periodontal diseases (time frame: At the time of study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01272570, which also lists 6 linked publications.
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 27 May 2015.