Phase III study of preoperative steroid compared with placebo for head and neck cancer surgery
- Conditions
- Head and Neck NeoplasmsHead and Neck CancerD006258
- Registration Number
- JPRN-jRCTs031210593
- Lead Sponsor
- Matsuura Kazuto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
1) Twenty years old or more
2) Head and neck surgery with free tissue transfer reconstruction is planned for head and neck malignancy.
3) Written consent is obtained.
4) ECOG PS 0-2
1) Hypersensitivity with dexamethasone
2) Taking the following drugs; disulfiram, cyanamide, desmopressin acetate hydrate, rilpivirine hydrochloride, rilpivirine hydrochloride/tenofovir alafenamide fumarate/emtricitabine, rilpivirine hydrochloride/tenofovir disoproxil fumarate/emtricitabine, rilpivirine hydrochloride/dolutegravir sodium, daclatasvir hydrochloride, asunaprevir, daclatasvir hydrochloride/asunaprevir hydrochloride
3) Having active infections, such as tuberculosis, viral diseases, or mycoses
4) Active thrombosis
5) Uncontrolled diabetes that requires regular insulin use
6) Psychiatric disorder or symptom that interferes with daily activities
7) Active peptic ulcers
8) Uncontrolled glaucoma
9) Immunosuppressants such as oral steroids taken continuously from before surgery
10) History of radiation therapy to the head and neck region
11) Difficulty obtaining PRO, QOR-40J and VAS scores for reasons such as cognitive decline, total blindness, or writing blindness
12) Physical activity is considered to be significantly impaired preoperatively due to for instance paralysis associated with cerebral infarction and so on
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of postoperative recovery (AUC values of QOR40-J total score on postoperative day2 and day4)
- Secondary Outcome Measures
Name Time Method