Breast CancerPhase 3NCT02376985
Evaluation of Oral Care to Prevent Oral Mucositis in ER Positive MBC Patients Treated With Everolimus: Phase 3 RCT
A Phase 3 study testing Oral management and Everolimus in people with Breast Cancer, run by Comprehensive Support Project for Oncology Research at 1 site in Japan.
Trial summary
To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental and oral surgeons (dental oral management group) and an observation group (brushing instruction only group) in a randomized, controlled… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Oral management and Everolimus
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteJapan
- Study dates
- 26 Mar 2015to 16 Oct 2018
- Phase
- Phase 3
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with a histological diagnosis of breast cancer (regardless of histological subtype of breast cancer).
- Diagnosis of metastatic or recurrent breast cancer satisfies either of the below.
- Distant metastasis present that is inoperable at time of first examination (Stage IV, 3.1 Clinical stage classification)
- Progression of distant metastasis or recurrence of breast cancer after treatment (after surgery and after treatments prior to and after surgery)
- Histologically confirmed diagnosis of ER-positive breast cancer
- Postmenopause
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- Any of the below conditions indicating resistance to aromatase inhibitor therapy. The aromatase inhibitor therapy need not be the most recent therapy.
- Recurrence during ongoing adjuvant therapy with an aromatase inhibitor, or recurrence within 12 months after adjuvant therapy with an aromatase inhibitor
- Progression during ongoing aromatase inhibitor therapy for advanced breast cancer, or progression within 1 month after ending aromatase inhibitor therapy
- Any number of chemotherapy (anti-neoplastic drugs) are allowed since diagnosis of metastatic or recurrent breast cancer
- Aged ≥20 years
- PS of 0-1. (ECOG scale).
- Previous treatment (including adjuvant therapy) satisfies all the conditions below.
- Hormone therapy: At least 7 days have elapsed from the last administration of hormonal therapy.
- Radiotherapy: At least 14 days have elapsed from the last irradiation.
- Organ function (within 4 weeks before enrollment) satisfies all the conditions below.
- Neutrophil count (band cells + segmented cells) of ≥1,500/mm3, or white blood cell count of ≥3,000/mm3
- Platelet count of ≥100,000/mm3
- Total bilirubin of ≤2.5 × ULN
- AST (GOT) and ALT (GPT) of ≤2.5 × ULN
- Serum creatinine of ≤1.5 × ULN
- Cardiac function satisfies either of the below.
- No cardiac disorder: No fatigue, palpitation, shortness of breath, or anginal pain during everyday activities as confirmed by interview.
- Has a cardiac disorder that does not limit movement, patient is confirmed to experience no fatigue, palpitation, shortness of breath, or anginal pain during everyday activities, and this health status is deemed to be maintained during treatment.
- Informed consent is obtainable from the subject herself in documented form using the Consent Form.
Who cannot join
- Edentulous jaw (in both upper and lower jaws)
- Occurrence of oral mucositis within 1 month prior to randomization
- Chemotherapy used within 1 month prior to randomization
- Exemestane monotherapy (this exclusion criterion is not met if ≥3 months has elapsed since the last exemestane treatment) as most recent therapy
- Previous mTOR inhibitor treatment (everolimus, etc.)
- Interstitial pneumonia or pulmonary fibrosis.
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- Received drug treatment known to have a strong inhibitory or inductive effect on the cytochrome P450 (CYP) 3A isozymes (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) (See Table 4.1.2.1 and 4.1.2.2 for lists of prohibited concomitant drugs).
- Positive result of HBs antigen, HBc antibody and/or HBs antibody.
- HCV infection or a history of HCV infection.
- History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation.
- Multiple active cancers (homochronous multiple cancers, or heterochronous multiple cancers with a cancer-free period of less than 5 years prior to randomization).
- Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer.
- Overexpression of HER2 (Her2/neu, Erb B2), and the condition is considered to be indicated for trastuzumab (herceptin®) treatment (when the state of HER2 expression is unknown, the patient is not excluded, but is treated as eligible).
- In other words, patients that satisfy any of the below conditions will be excluded.
- At either the primary or the metastatic lesion:
- Strongly positive, "3+" by HER2 IHC.
- Positive "+" by FISH
- Brain metastasis that requires treatment for intracranial hypertension or emergency irradiation of the brain.
- Extensive liver metastasis, or lymphangitic lung metastasis with accompanying dyspnea.
- Pleural effusion, ascites, or pericardial effusion that requires emergency treatment.
- Concurrent and active infectious disease.
- With uncontrolled diabetes mellitus or currently receiving insulin therapy.
- Difficulty to participate in this study due to mental illness or psychiatric symptoms.
- With another reasons recognized as inadequate to participate in this study by doctors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Oral Care to Prevent Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated With Everolimus: Phase III Randomized Control Trial
To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental and oral surgeons (dental oral management group) and an observation group (brushing instruction only group) in a randomized, controlled study in females that are using everolimus for estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.
Read the detailed description
To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental surgeons or oral surgeons (hereafter referred to as, "dental and oral surgeons") and an observation group in a randomized, controlled study in females that are using everolimus for estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.
The objectives of this study are as described below.
- To examine whether the occurrence of oral mucositis can be reduced by implementing dental oral management prior to everolimus treatment.
- To examine whether the frequency and duration of oral mucositis can be reduced and reductions in the dose of everolimus can be reduced by implementing dental oral management prior to everolimus treatment.
- To examine whether treatment of oral mucositis of over Grade 1 with dexaltin ointment as dental oral management can reduce the occurrence of Grade 2 oral mucositis.
- To evaluate the health-related quality of life (HRQOL) in a group that implements dental oral management prior to everolimus treatment and a group that does not.
- To establish and strengthen cooperation and organize and expand and information distribution network through the participation of oncologists and specialists in breast cancer treatment (hereafter referred to as, "oncologists") and dental and oral surgeons in clinical studies.
- Conditions
- Breast Cancer
- Being tested
- Oral management, Everolimus
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral managementProcedure or surgery
EverolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Brushing instruction group | Placebo comparator | Drug: Everolimus and Exemestane Everolimus, 10 mg/day Exemestane, 25 mg/day Administration on consecutive days once daily after breakfast until tumor progression or for a minimum 8 weeks.
Oral treatment:
Brushing and gargling with saline after every meal (initially instructed by a dental/oral surgeon). Receives: Drug: Everolimus |
| Dental oral management group | Experimental | Drug: Everolimus and Exemestane Everolimus, 10 mg/day Exemestane, 25 mg/day Administration on consecutive days once daily after breakfast until tumor progression or for a minimum 8 weeks.
Oral treatment:
Scaling and enamel polishing will be performed by a dental and oral surgeon or dental hygienist before everolimus treatment, and once weekly after everolimus treatment.
Brushing and gargling with Neostelin Green 0.2% mouthwash solution after every meal (initially instructed by a dental/oral surgeon). Receives: Procedure: Oral management; Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of oral mucositis (Over Grade 1) after everolimus treatment
Incidence of oral mucositis in Grade 1 or more, is evaluated by an oncologist.
Measured: Patients are followed up for 8 weeks after initial enrollment
Secondary outcomes (10)
Incidence of oral mucositis (Over Grade 2)
Incidence of oral mucositis in Grade 2 or more, is evaluated by an oncologist.
Measured: Patients are followed up for 8 weeks after initial enrollment
Incidence of oral mucositis (Over Grade 3)
Incidence of oral mucositis in Grade 3 or more, is evaluated by an oncologist.
Measured: Patients are followed up for 8 weeks after initial enrollment
Incidence of oral mucositis (Over Grade 1)
Incidence of oral mucositis in Grade 1 or more, is evaluated by a dental and oral surgeon
Measured: Patients are followed up for 8 weeks after initial enrollment
Incidence of oral mucositis (Over Grade 2)
Incidence of oral mucositis in Grade 2 or more, is evaluated by a dental and oral surgeon
Measured: Patients are followed up for 8 weeks after initial enrollment
Incidence of oral mucositis (Over Grade 3)
Incidence of oral mucositis in Grade 3 or more, is evaluated by a dental and oral surgeon
Measured: Patients are followed up for 8 weeks after initial enrollment
Time to the onset of oral mucositis
Time to the onset of mucositis is evaluated by an oncologist or a dental/oral surgeon
Measured: Patients are followed up for 8 weeks after initial enrollment
Duration of each Grade of oral mucositis
Duration of each Grade of mucositis is evaluated by an oncologist or a dental/oral surgeon, respectively
Measured: Patients are followed up for 8 weeks after initial enrollment
Each ratio of patients in suspension, or dose-reduction of everolimus treatment due to oral mucositis
Suspension or dose-reduction of everolimus treatment is evaluated by an oncologist
Measured: Patients are followed up for 8 weeks after initial enrollment
Oral Assessment Guide (Revised)
Oral assessment guide is evaluated by a dental/oral surgeon
Measured: Patients are followed up for 8 weeks after initial enrollment
Health-related quality of life (HRQOL)
Following QOL questionnaire from (in Japanese) are used for evaluation: FACT-G, GOHAI and SF-36
Measured: Evaluations are executed after the patient enrollment, 4 weeks and the end (8 weeks) of the initiation of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start26 Mar 2015
- Primary completion31 Mar 2018
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comprehensive Support Project for Oncology Research
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Akira Yamao, Principal investigator, Public Health Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376985
- Sponsor's protocol ID
- Oral Care-BC
- Status last verified
- Jul 2019
- First submitted
- 26 Feb 2015
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nakatsukasa K, Niikura N, Kashiwabara K, Amemiya T, Watanabe KI, Hata H, Kikawa Y, Taniike N, Yamanaka T, Mitsunaga S, Nakagami K, Adachi M, Kondo N, Shibuya Y, Hayashi N, Naito M, Yamashita T, Umeda M, Mukai H, Ota Y. Secondary endpoints analysis in patients with estrogen receptor-positive metastatic breast cancer treated with everolimus and exemestane enrolled in Oral Care-BC. BMC Cancer. 2021 Jan 7;21(1):34. doi: 10.1186/s12885-020-07746-9.
PubMed 33413212
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Care to Prevent Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated With Everolimus: Phase III Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02376985
- Acronym / sponsor ID
- Oral Care-BC
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Comprehensive Support Project for Oncology ResearchUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 3 Mar 2015 (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.
To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental and oral surgeons (dental oral management group) and an observation group (brushing instruction only group) in a randomized, controlled study in females that are using everolimus for estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.
Detailed description
To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental surgeons or oral surgeons (hereafter referred to as, "dental and oral surgeons") and an observation group in a randomized, controlled study in females that are using everolimus for estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.
The objectives of this study are as described below.
- To examine whether the occurrence of oral mucositis can be reduced by implementing dental oral management prior to everolimus treatment.
- To examine whether the frequency and duration of oral mucositis can be reduced and reductions in the dose of everolimus can be reduced by implementing dental oral management prior to everolimus treatment.
- To examine whether treatment of oral mucositis of over Grade 1 with dexaltin ointment as dental oral management can reduce the occurrence of Grade 2 oral mucositis.
- To evaluate the health-related quality of life (HRQOL) in a group that implements dental oral management prior to everolimus treatment and a group that does not.
- To establish and strengthen cooperation and organize and expand and information distribution network through the participation of oncologists and specialists in breast cancer treatment (hereafter referred to as, "oncologists") and dental and oral surgeons in clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brushing instruction group | Placebo comparator | Drug: EverolimusDrug: Everolimus and Exemestane Everolimus, 10 mg/day Exemestane, 25 mg/day Administration on consecutive days once daily after breakfast until tumor progression or for a minimum 8 weeks. Oral treatment: Brushing and gargling with saline after every meal (initially instructed by a dental/oral surgeon). |
| Dental oral management group | Experimental | Procedure: Oral management, Drug: EverolimusDrug: Everolimus and Exemestane Everolimus, 10 mg/day Exemestane, 25 mg/day Administration on consecutive days once daily after breakfast until tumor progression or for a minimum 8 weeks. Oral treatment: Scaling and enamel polishing will be performed by a dental and oral surgeon or dental hygienist before everolimus treatment, and once weekly after everolimus treatment. Brushing and gargling with Neostelin Green 0.2% mouthwash solution after every meal (initially instructed by a dental/oral surgeon). |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Female patients with a histological diagnosis of breast cancer (regardless of histological subtype of breast cancer).
- Diagnosis of metastatic or recurrent breast cancer satisfies either of the below.
- Histologically confirmed diagnosis of ER-positive breast cancer
- Postmenopause
- Any of the below conditions indicating resistance to aromatase inhibitor therapy. The aromatase inhibitor therapy need not be the most recent therapy.
Key exclusion criteria (24 listed)
- Edentulous jaw (in both upper and lower jaws)
- Occurrence of oral mucositis within 1 month prior to randomization
- Chemotherapy used within 1 month prior to randomization
- Exemestane monotherapy (this exclusion criterion is not met if ≥3 months has elapsed since the last exemestane treatment) as most recent therapy
- Previous mTOR inhibitor treatment (everolimus, etc.)
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 |
|---|---|---|
| Oral management | Procedure or surgery | Dental oral management group |
| Everolimus | Drug | Brushing instruction group, Dental oral management group |
Primary outcome
Incidence of oral mucositis (Over Grade 1) after everolimus treatment
Time frame: Patients are followed up for 8 weeks after initial enrollment
Incidence of oral mucositis in Grade 1 or more, is evaluated by an oncologist.
10 secondary outcomes
Incidence of oral mucositis (Over Grade 2)
Time frame: Patients are followed up for 8 weeks after initial enrollment
Incidence of oral mucositis (Over Grade 3)
Time frame: Patients are followed up for 8 weeks after initial enrollment
Incidence of oral mucositis (Over Grade 1)
Time frame: Patients are followed up for 8 weeks after initial enrollment
Incidence of oral mucositis (Over Grade 2)
Time frame: Patients are followed up for 8 weeks after initial enrollment
Incidence of oral mucositis (Over Grade 3)
Time frame: Patients are followed up for 8 weeks after initial enrollment
Time to the onset of oral mucositis
Time frame: Patients are followed up for 8 weeks after initial enrollment
Duration of each Grade of oral mucositis
Time frame: Patients are followed up for 8 weeks after initial enrollment
Each ratio of patients in suspension, or dose-reduction of everolimus treatment due to oral mucositis
Time frame: Patients are followed up for 8 weeks after initial enrollment
Oral Assessment Guide (Revised)
Time frame: Patients are followed up for 8 weeks after initial enrollment
Health-related quality of life (HRQOL)
Time frame: Evaluations are executed after the patient enrollment, 4 weeks and the end (8 weeks) of the initiation of the treatment.
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 21 Oct 2019.
- Derived from this study: PubMed 33413212Nakatsukasa K, Niikura N, Kashiwabara K, Amemiya T, Watanabe KI, Hata H, Kikawa Y, Taniike N, Yamanaka T, Mitsunaga S, Nakagami K, Adachi M, Kondo N, Shibuya Y, Hayashi N, Naito M, Yamashita T, Umeda M, Mukai H, Ota Y. Secondary endpoints analysis in patients with estrogen receptor-positive metastatic breast cancer treated with everolimus and exemestane enrolled in Oral Care-BC. BMC Cancer. 2021 Jan 7;21(1):34. doi: 10.1186/s12885-020-07746-9.
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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.
Akira Yamao principal investigator
Public Health Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral management and Everolimus in people with Breast Cancer, run by Comprehensive Support Project for Oncology Research at 1 site in Japan.
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 25 inclusion and 24 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 21 Oct 2019. 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 Japan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of oral mucositis (Over Grade 1) after everolimus treatment (time frame: Patients are followed up for 8 weeks after initial enrollment). 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 NCT02376985, which also lists 1 linked publication.
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 21 Oct 2019.