Antiresorptive Drug Continuation Compared With Drug Holiday in Cancer Patients Needing Tooth Extraction
NCT ID: NCT04540601
Last Updated: 2020-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2018-07-10
2020-08-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Research question: Does a drug holiday have any influence on health related quality of life or the incidence of developing osteonecrosis of the jaw after surgical tooth extraction? The investigators hypothesize that a drug holiday 1 month before to 3 months after surgical tooth extraction in cancer patients do not influence the development of osteonecrosis of the jaw and may even affect the health related quality of life negatively.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Assessment of Preoperative Versus Postoperative Submucosal Dexamethasone on Postoperative Complications Following Surgical Extraction of Mandibular Third Molar: Randomized Controlled Trial
NCT06160180
First-in-man Study of Adult Patients Suffered From Alveolar Osteitis Treated Using Stomatological Tamponade Contipro
NCT04091399
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940
NCT00659490
Comparison of the Anti-Inflammatory Efficacy of Preemptive Dexamethasone and Etoricoxib
NCT05142098
Alternatives to Dental Opioid Prescribing After Tooth Extraction
NCT06275191
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The aim of this trial is therefore to clarify the meaning of high-dose antiresorptive drug holiday related to tooth extraction with primary mucosal closure in cancer patients and reveal how a drug holiday affects the health related quality of life. A continuation of the patients' antiresorptive treatment can possibly lead to increased risk of osteonecrosis of the jaw, but with the operation procedure with primary closure it is unlikely. It is beneficial for the cancer patients to continue the high dose antiresorptive therapy because a drug holiday is a stop in their anti-cancer treatment with risk of increased pain as well as unwanted skeletal events to occur, and potentially progress of metastases to follow.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The participating patients will not be blinded. The patients do know which group they are randomized to and therefore do know if they are treated with or without drug holiday during the trial period (1+3 months). The patients are carefully instructed not to reveal which group they belong during the trial to the assessor.
Klaus Gotfredsen will make sure that the patients randomized to the intervention group will continue their antiresorptive therapy and the patients randomized to the control group will be treated with drug holiday this in close collaboration with the oncological departments. The medicine will be giving to the patient by the department's nurse.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cancer patients, randomized A
Patients in high-dose antiresorptives with bone metastases
Continuation of antiresorptives in relation to tooth extraction (surgical tooth removal)
We want to investigate the importance of an antiresorptive drug holiday (bisphosphonate, denosumab) in relation to tooth extraction. The experimental intervention in this trial is drug continuation starting before tooth extraction with primary closure.
We simply ask the participating cancer patients to continue their high dose antiresorptive treatment for 4 months (intervention-period: 1 month pre-operative, 3 months post-operative) instead of taking a drug holiday.
Cancer patients, randomized B
Drug Holiday as standard operation procedure
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Continuation of antiresorptives in relation to tooth extraction (surgical tooth removal)
We want to investigate the importance of an antiresorptive drug holiday (bisphosphonate, denosumab) in relation to tooth extraction. The experimental intervention in this trial is drug continuation starting before tooth extraction with primary closure.
We simply ask the participating cancer patients to continue their high dose antiresorptive treatment for 4 months (intervention-period: 1 month pre-operative, 3 months post-operative) instead of taking a drug holiday.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients aged 18 years or older.
* Patients with malignant disease (breast or prostate cancer, multiple myeloma) and metastases to the skeleton.
* Patients present high dose/intravenous antiresorptive therapy for at least 1 month.
* Patients who need tooth extraction. Indications for extraction include root fracture, endodontic failure, severe periodontal disease, non-restorable caries and teeth with a poor prognosis or at high risk of infection, complications.
* Patients who have an ECOG (Eastern Cooperative Oncology Group) score \< 2 (30). Definition of ECOG 0. Fully active, able to carry on all pre-disease performance without restriction.
1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g., light house work, office work.
2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of walking hours.
3. Capable of only limited selfcare, confined to bed or chair more than 50% of walking hours.
4. Completely disabled. Cannot carry on selfcare. Totally confined to bed or chair.
* Signed informed content.
Exclusion Criteria
* Patients must not have exposed bone, or signs of non-exposed bone.
* Patients previous diagnosed with ONJ.
* Patients who are unable to cooperate or too ill to complete the experiment.
* Lack of signed informed consent.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Camilla Ottesen
DDS, PhD fellow
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Copenhagen University Hospital
Copenhagen, Copenhagen Ø, Denmark
University of Copenhagen, Department of Odontology
Copenhagen, Nørrebro, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-18007990
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.