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ID
Source
Brief title
Health condition
Esophageal cancer, esophagectomy, postoperative complications, cardiopulmonary complications, anastomic leakage, Quality of Life
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Predicted VO2max (ml/kg/min)
Secondary outcome
- All 30-day and in-hospital postoperative complications specifically:
> Cardiopulmonary complications
- Other PREPARE measurements, e.g.:
Maximum power output/wattage (Wmax)
> Predicted VO2peak (ml/kg/min)
> Maximum inspiratory pressure (MIP)
> Spirometry measurements (e.g. forced expiratory volume in 1 second; FEV1)
- Functional recovery, total length of hospital and ICU stay and readmission rate
- Quality of life (EuroQol EQ-5D-5L and EORTC QLQ-C30 validated questionnaires)
Background summary
BEET-MIE is a 2-arm RCT investigating the added effect of one consecutive week of beetrootjuice (BRJ) consumption in prehabilitated patients scheduled to undergo a minimally invasive esophagectomy for cancer. Primarily the impact on VO2max. Cardiopulmonary complications, functional recovery, surgical complications and quality of life amongst others are also carefully monitored.
Study objective
It has been reported that patients with lower VO2max and VO2peak (the peak oxygen uptake during incremental exercise) values, have a significantly higher risk of cardiopulmonary complications (CPC) following an esophagectomy, while consumption of beetroot juice has been shown in multiple studies to improve exercise performance and oxygen metabolism (including VO2max and VO2peak) in both young, healthy individuals as well as the elderly suffering from cardiovascular disease and COPD.
Study design
- VO2max and other PREPARE measurements: 1 week preoperatively and at admission on the day before surgery
- Functional recovery: during admission.
- Cardiopulmonary complications: within 30 days after surgery.
- Anastomotic leakage: within 30 days after surgery by clinical/radiological signs or confirmed by reoperation
- All other (surgical) complications: within 30 days after surgery
- Quality of life: baseline, 1 week preoperatively, at admission on the day before surgery, 1 week, 3 weeks, and 6 weeks postoperatively
Intervention
Nitrate-rich Beet It Sport shot (70cc) versus nitrate-depleted Beet It Sport shot (placebo, 70cc). Depending on randomization patients will be take 1 bottle once daily for seven consecutive days directly before surgery.
The aforementioned PREPARE program is a personalized, home-based prehabilitation program for all esophageal cancer patients scheduled to undergo an elective esophagectomy. Nutritional status, physical capacity and mental wellbeing of patients is optimized in collaboration with and under supervision of a multidisciplinary team from the hospital. The PREPARE program has already been fully implemented since 2018.
Thijs Janssen
(+31)040 - 239 7169 or (+31)040 - 239 6350
Thijs.janssen@catharinaziekenhuis.nl
Thijs Janssen
(+31)040 - 239 7169 or (+31)040 - 239 6350
Thijs.janssen@catharinaziekenhuis.nl
Inclusion criteria
- Prehabilitated patients undergoing an elective minimally invasive Ivor-Lewis esophagectomy with intrathoracic anastomosis
- Written informed consent
- Age >18 years
Exclusion criteria
Allergy to beets/BRJ
Inability to tolerate oral intake, e.g. swallowing disorder
Inability to follow the PREPARE program
Inability to provide written consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8560 |
| CCMO | NL72405.100.20 |
| OMON | NL-OMON49240 |