HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): a randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible: study protocol for a randomised controlled trial

被引:12
作者
Shaw, Richard [1 ,2 ]
Butterworth, Christopher [1 ,2 ]
Tesfaye, Binyam [3 ]
Bickerstaff, Matthew [3 ]
Dodd, Susanna [4 ]
Smerdon, Gary [5 ]
Chauhan, Seema [3 ]
Brennan, Peter [6 ]
Webster, Keith [7 ]
McCaul, James [8 ]
Nixon, Peter [9 ]
Kanatas, Anastasios [9 ]
Silcocks, Paul [3 ]
机构
[1] Univ Liverpool, CRUK Liverpool Canc Trials Unit, Dept Mol & Clin Canc Med, Liverpool, Merseyside, England
[2] Aintree Univ Hosp NHS Fdn Trust, Liverpool, Merseyside, England
[3] Univ Liverpool, CRUK Liverpool Canc Trials Unit, Dept Mol & Clin Canc Med, Liverpool, Merseyside, England
[4] Univ Liverpool, Dept Biostat, Liverpool, Merseyside, England
[5] Devon Dis Res Ctr, Plymouth, Hants, England
[6] Portsmouth Hosp NHS Trust, Portsmouth, Hants, England
[7] Univ Hosp Birmingham NHS Fdn Trust, Queen Elizabeth Hosp, Birmingham, W Midlands, England
[8] Queen Elizabeth Univ Hosp, Glasgow, Lanark, Scotland
[9] Leeds Dent Inst, Leeds, W Yorkshire, England
来源
TRIALS | 2018年 / 19卷
关键词
DOUBLE-BLIND; NECK MALIGNANCY; UNITED-KINGDOM; RADIOTHERAPY; THERAPY; CANCER; HEAD; MANAGEMENT; UK;
D O I
10.1186/s13063-017-2376-7
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background: Osteoradionecrosis of the mandible is the most common serious complication of radiotherapy for head and neck malignancy. For decades, hyperbaric oxygen has been employed in efforts to prevent those cases of osteoradionecrosis that are precipitated by dental extractions or implant placement. The evidence for using hyperbaric oxygen remains poor and current clinical practice varies greatly. We describe a protocol for a clinical trial to assess the benefit of hyperbaric oxygen in the prevention of osteoradionecrosis during surgery on the irradiated mandible. Methods/design: The HOPON trial is a phase III, randomised controlled, multi-centre trial. It employs an unblinded trial design, but the assessment of the primary endpoint, i.e. the diagnosis of osteoradionecrosis, is assessed on anonymised clinical photographs and radiographs by a blinded expert panel. Eligibility is through the need for a high-risk dental procedure in the mandible where at least 50-Gy radiotherapy has been received. Patients are randomised 1:1 to hyperbaric oxygen arm (Marx protocol) : control arm, but both groups receive antibiotics and chlorhexidine mouthwash. The primary endpoint is the presence of osteoradionecrosis at 6 months following surgery, but secondary endpoints include other time points, acute symptoms and pain, quality of life, and where implants are placed, their successful retention. Discussion: The protocol presented has evolved through feasibility stages and through analysis of interim data. The classification of osteoradionecrosis has undergone technical refinement to ensure that robust definitions are employed. The HOPON trial is the only multi-centre RCT conducted in this clinical setting despite decades of use of hyperbaric oxygen for the prevention of osteoradionecrosis.
引用
收藏
页数:10
相关论文
共 29 条
[11]   THE CONSERVATIVE MANAGEMENT OF OSTEORADIONECROSIS OF THE MANDIBLE WITH ULTRASOUND THERAPY [J].
HARRIS, M .
BRITISH JOURNAL OF ORAL & MAXILLOFACIAL SURGERY, 1992, 30 (05) :313-318
[12]   Survey of the use of hyperbaric oxygen by maxillofacial oncologists in the UK [J].
Kanatas, A ;
Lowe, D ;
Harrison, J ;
Rogers, SN .
BRITISH JOURNAL OF ORAL & MAXILLOFACIAL SURGERY, 2005, 43 (03) :219-225
[13]   A survey of antibiotic prescribing by maxillofacial consultants for dental extractions following radiotherapy to the oral cavity [J].
Kanatas, AN ;
Rogers, SN ;
Martin, MV .
BRITISH DENTAL JOURNAL, 2002, 192 (03) :157-160
[14]   A NEW CONCEPT IN THE TREATMENT OF OSTEORADIONECROSIS [J].
MARX, RE .
JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY, 1983, 41 (06) :351-357
[15]   PREVENTION OF OSTEORADIONECROSIS - A RANDOMIZED PROSPECTIVE CLINICAL-TRIAL OF HYPERBARIC-OXYGEN VERSUS PENICILLIN [J].
MARX, RE ;
JOHNSON, RP ;
KLINE, SN .
JOURNAL OF THE AMERICAN DENTAL ASSOCIATION, 1985, 111 (01) :49-54
[16]   Incidence and prevention of osteoradionecrosis after dental extraction in irradiated patients: a systematic review [J].
Nabil, S. ;
Samman, N. .
INTERNATIONAL JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY, 2011, 40 (03) :229-243
[17]   Management of mandibular osteoradionecrosis corresponding to the severity of osteoradionecrosis and the method of radiotherapy [J].
Notani, K ;
Yamazaki, Y ;
Kitada, H ;
Sakakibara, N ;
Fukuda, H ;
Omori, K ;
Nakamura, M .
HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK, 2003, 25 (03) :181-186
[18]  
Piantadosi S, 2005, WILEY SER PROBAB ST, P1, DOI 10.1002/0471740136
[19]   Double-blind randomized phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy [J].
Pritchard, J ;
Anand, P ;
Broome, J ;
Davis, C ;
Gothard, L ;
Hall, E ;
Maher, J ;
McKinna, F ;
Millington, J ;
Misra, VP ;
Pitkin, A ;
Yarnold, JR .
RADIOTHERAPY AND ONCOLOGY, 2001, 58 (03) :279-286
[20]   Survey of fellows regarding a national study into treatment with hyperbaric oxygen [J].
Rogers, Simon N. ;
Magennis, Patrick .
BRITISH JOURNAL OF ORAL & MAXILLOFACIAL SURGERY, 2007, 45 (05) :433-435