Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

Bladder Cancer Clinical Trial

— STOP-OP  

Official title:

Randomised Controlled Multicenter Study.Effect of an Intensive Smoking- and/or Alcohol Cessation Intervention Placed Shortly Before and 5 Weeks After Bladder Cancer Surgery on Postoperative Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188446
• Other study ID #: F-22841-01
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: July 2018

Study information

• Verified date: January 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol consumption above two drinks per day is associated with an increased risk of postoperative morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is recommended to reduce this risk, but for cancer patients the preoperative period is often very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the Gold Standard Programme (GSP) on the frequency and severity of postoperative complications after bladder cancer surgery.

Description:

The study is a multicentre randomised clinical trial involving 110 patients with a risky alcohol intake (exceeding 21 alcohol units (252 g ethanol) per week or/ and daily smoking scheduled for bladder cancer surgery. Patients will be randomised to the 6-weeks GSP or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. The GSP includes benzodiazepine therapy for withdrawal symptoms, controlled disulfiram therapy, and Nicotine replacement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients > 18 years scheduled for cystectomy due to bladder cancer

• Daily smoker or/and intake of

->21 units (252 g) of alcohol pr week

• Informed consent

Exclusion Criteria:

• Cancelled operation

• Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement

• Pregnant or breastfeeding women

• Mentally incompetent patients

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Bladder Cancer
• Postoperative Complications
• Smoking
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Educational programme for smoking and alcohol cessation
5 meetings within 6 weeks containing education and pharmacologic support

Locations

Country	Name	City	State
Denmark	Department of Urology, University Hospital of Copenhagen	Copenhagen

Sponsors (7)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg Universitetshospital, Aarhus University Hospital, Copenhagen University Hospital at Herlev, Frederiksberg University Hospital, Karolinska Institutet, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with postoperative complications	Both number of patients with postoperative complications and number of postoperative complications according to the Clavien Dindo classification will be measured	Up to 6 weeks
Secondary	Postoperative complications		up to 90 days
Secondary	Smoking and alcohol cessation up to 12 months postoperatively Smoking and alcohol cessation		Up to 12 months postoperatively
Secondary	Length of stay		From day of surgery to day of discharge
Secondary	Time to return to work or habitual level of activity		Up to 12 months
Secondary	Mortality		Up to 12 months postoperatively
Secondary	Quality of life ( EORTC QLQ BLM 30 and EQ5D)		Up to 12 months postoperatively

External Links

•   DaBlaCa study number 6