The purpose of this research is to investigate the effect of early multimodal preconditioning for patients who will undergo esophaguscardiaresection will lead to improvement of cardiorespiratory fitness, nutritional status and quality of life. This…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Cardiorespiratory fitness: consisting of VO2 max measurement, spirometry
lungfunction and mouthpressure
* Nutritional status
o BMI
o Weight
o Muscleforce of the hand, triceps and quadriceps
o MUST score
o Nutritional Risk Index and Instant Nutritional Assesment
* Quality of Life measured with the EORTC QLQ-C30 and OES18 questionnaires
Secondary outcome
* Postoperative complications
* Length of hospital stay
* Length of stay on intensive care unit
* Mortality
* Re-admission
Background summary
The incidence of esophageal cancer has strongly increased the last 15 year,
from 5.4 to 9.5 per 100.000. The 5-year survival rate after curative therapy
seems to increase slowly from ±15% to ±35%. The curative treatment of
esophageal cancer consists of radical resection (esophagus cardia resection,
OCR), preceded by neoadjuvant chemoradiation. Esophagus cardia resections are
seen as low-volume, high-risk surgery. Cardiorespiratory fitness, muscleforce,
nutritional status and quality of life are threatened in patients with
esophageal carcinoma. Especially these aspects have an assumed negative effect
on postoperative outcome measures like length of hospital stay, morbidity and
mortality. It has recently been demonstrated that some of those aspects can
generally be improved preoperative. This resulted in improvement of the
postoperative outcome measurements.
Study objective
The purpose of this research is to investigate the effect of early multimodal
preconditioning for patients who will undergo esophaguscardiaresection will
lead to improvement of cardiorespiratory fitness, nutritional status and
quality of life. This could come with improvement of postoperative morbidity
and mortality.
Study design
This will be a RCT study where 38 patients will follow the preconditioning
protocol compared to 38 patients who will receive the usual current care during
the period from shortly after the diagnosis untill surgery.
Intervention
The interventiongroup will receive the next interventions:
Nutrition:
Two weekly consults consisting of nutritional assessment, MUST score,
measurement of energy and protein intake and BMI. If there is (a risk of)
malnutrition, the patient will get an individualized nutrition plan, consisting
of not only advice, but also strict nutritional support. During the treatment
the objective is nutrition consisting of sufficient protein and energy values
according to the CBO guidelines of perioperative nourishment.
Physical therapy:
Daily physical therapy for 15 minutes with an inspiratory threshold device at
home. Supervised physical therapy two times a week for two hours preferably in
the Atrium MC Heerlen. This physical therapy consists of training on the
treadmill, hometrainer. Specific musclegroups will be trained with weights.
This all to improve the patient's cardiorespiratory fitness.
The interventiongroup as well as the controllgroup will be subject to
measurements three times during the preconditioning path. This will be done
before and after neoadjuvant therapy and shortly before surgery.
The lungfunction department will be involved by taking the spirometry tests
including the mouthpressure. They will also do the VO2 max test.
The physical therapist will measure weight, muscleforce of the hand, triceps
and quadriceps using a grip strength dynamometer and microFET.
Bloodsamples will be taken three times during the path. Additionally patients
will have to fill in Quality of Life questionnaires and the MUST score
(malnutrition) will be determined. Quality of Life will be determined also four
weeks postoperative.
Study burden and risks
This research is aggravating for patients. Time investment needs to be made and
it will take physical effort, depending on the group. Measurement of the VO2
max will be the most intensive test for patients. The Atrium MC has a
centerfunction for Limburg, but not all patients live nearby. The
traveldistance will cause extra effort for those living far from the Atrium MC.
There are no known risks for this research, except for infection and bleeding
after bloodsampling.
Henri Dunantstraat 5
6401 CX Heerlen
NL
Henri Dunantstraat 5
6401 CX Heerlen
NL
Listed location countries
Age
Inclusion criteria
Patients (> age 18) with esophageal, who will have resection after neoadjuvant therapy.
Exclusion criteria
Absence of a signed informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL38167.096.11 |