Osteonecrosis Due to Drugs, Jaw Clinical Trial
— DrugHolidayOfficial title:
Antiresorptive Drug Continuation Compared With Drug Holiday in Cancer Patients Needing Tooth Extraction - A Randomized Clinical Trial
Verified date | September 2020 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this trial is to evaluate high-dose antiresorptive drug holiday related to tooth
extraction with primary mucosal closure (surgical extraction) including how a drug holiday
affects the health related quality of life.
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 19, 2020 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients eligible for the trial must comply with all of the following at randomization: - 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 received radiation therapy to the jaws. - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Copenhagen University Hospital | Copenhagen | Copenhagen Ø |
Denmark | University of Copenhagen, Department of Odontology | Copenhagen | Nørrebro |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of osteonecrosis of the jaw (ONJ) or incomplete healing at 3 months follow-up | The outcome assessor has 3 options for registration related to ONJ occurrence: Complete healing = mucosal covering = no sign of ONJ, defined as complete wound healing; Intact mucosa, that is total mucosal covering over the tooth extraction area. Incomplete healing = presence of fibrin covering partly or over all mucosal operation area; Defined as the presence of fibrin at the surface of the operation area, thus still being a wound. ONJ present, defined according to the AAOMS position paper 2014 (4), all three items have to be present: Current or previous treatment with antiresorptive agents. Exposed bone or bone that can be probed through an extraoral or intraoral fistula that has persisted for longer than 8 weeks. No history of radiation therapy to the jaws or obvious metastatic disease to the jaws. |
3 months follow-up | |
Primary | EQ-5D-5L: Change in patients health related quality of life from allocation/enrollment | The patients are given the EQ-5D-5L questionnaire. The 5-level EQ-5D version (EQ-%D-5L) was introduced by the EuroQol Group in 2009 and consists of two pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, serve problems and extreme problems. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The Danish dataset (SPSS syntax crosswalk values EQ-5D-5L Denmark) will be used to analyze patients´ responses. | The patient will be asked to fulfill the EQ-5D-5L at allocation/enrollment and again at 1, 3 and 6 months follow-up. | |
Secondary | Pain from the jaw | Pain from the jaw is registered by a Visual Analogue Scale (VAS). The investigator will give the patient a paper with a VAS, see attached appendix 3, and ask following question: "On a scale from 0 to 10, where 0 is no pain and 10 is the worst thinkable pain, mark at the scale how much pain you feel from your jaw at tooth operation site". | This is asked prior to tooth extraction (time 0), at suture removal (time 10-14 days), at 1-month follow-up and at 3 and 6 months follow-up and is registered in the datasheet. | |
Secondary | Incidence of unwanted skeletal events | The patient is giving a simple questionnaire, where they have to answer yes or no to following question: "Have you visited your own doctor or been hospitalized because of fractures or other skeletal complications during this trial period - yes or no. If yes, please write why." See attached appendix 4: Skeletal-related event questionnaire | Incidence (number of) unwanted skeletal events during the period and is registered at 3 and 6 months follow-up. | |
Secondary | Progression of cancer disease | The tumor-evaluation will be done by the oncologic doctor in due to their departments routine. | The patient will be weighted at baseline, time of tooth removal, 1 month follow-up, 3 and 6 months follow-up visit. |
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