Phase III study of preoperative steroid compared with placebo for head and neck cancer surgery

JRCT ID: jRCTs031210593

Registered date:02/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Head and Neck Neoplasms
• Date of first enrollment: 02/02/2022
• Target sample size: 180
• Study type: Interventional

Intervention(s)

Arm A: Perioperative management with ERAS without preoperative steroid administration
Arm B: Perioperative management with ERAS with preoperative steroid administration

Outcome(s)

• Primary Outcome: Quality of postoperative recovery (AUC values of QOR40-J total score on postoperative day2 and day4)

Secondary Outcome

Key secondary endpoint
1) Postoperative pain (AUC values of VAS scores on postoperative days 1, 2, and 3)
2) Postoperative nausea (AUC values of VAS scores on postoperative days 1, 2, and 3)
Secondary endpoint
1) QOR-40 J total score on postoperative days 2, 4, and 7
2) QOR-40 J score of respective dimensions of Comfort, Physical independence, Patient support, Pain, and Emotions on postoperative days 2, 4, and 7
3) length of postoperative hospital stay
4) Duration until the completion of postoperative discharge criteria
5) Degree of postoperative pain (VAS score, postoperative fentanyl requirement, use of analgesic rescue)
6) Degree of postoperative nausea and vomiting (VAS score, use of antiemetic rescue)
7) Start of enteral nutrition
8) Discontinuation of enteral nutrition
9) Early mobilization
10) Perioperative complication
11) Inflammatory responses (IL -6, CRP, albumin, neutrophils, lymphocytes,)
12) Fluid balance (Changes in body weight, presence or absence of hypotension)
13) Glycemic control
14) Occurrence of delirium

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Matsuura Kazuto
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development