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A randomized controlled trial on the effect of beetroot juice on VO2max in patients undergoing a minimally invasive esophagectomy

BEETrootjuice and prehabilitation in patients undergoing a Minimally Invasive Esophagectomy (BEET-MIE)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20212
Enrollment
100
Registered
2019-12-01
Start date
2020-10-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer, esophagectomy, postoperative complications, cardiopulmonary complications, anastomic leakage, Quality of Life

Interventions

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 direc

Sponsors

Catharina Hospital Eindhoven
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Prehabilitated patients undergoing an elective minimally invasive Ivor-Lewis esophagectomy with intrathoracic anastomosis - Written informed consent - Age >18 years

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
- Predicted VO2max (ml/kg/min)

Secondary

MeasureTime frame
- 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)

Contacts

Public ContactThijs Janssen

Catharina Ziekenhuis Eindhoven

Thijs.janssen@catharinaziekenhuis.nl(+31)040 - 239 7169 or (+31)040 - 239 6350

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)