The purpose of this research is to investigate the effect and feasability of multimodal preconditioning for patients who will undergo esophaguscardiaresection.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Scores on the questionnaires, long function, muscle force measurements, BMI,
handdynamometry.
Secondary outcome
Complications, hospital length of stay, re-admission and mortality.
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%.
Because of agreements in the region, curative esophaguscardiaresections (OCR)
of Southern Limburg are situated at AtriumMC, Heerlen. On yearly basis an
amount of 40-45 patients is expected.
Study objective
The purpose of this research is to investigate the effect and feasability of
multimodal preconditioning for patients who will undergo
esophaguscardiaresection.
Study design
This will be a prospective pilot study where 10 patients will follow the
preconditioning protocol compared to 10 patients who will receive the usual
care during the period between neoadjuvant therapy and surgery.
Intervention
Nutrition: 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
not only of 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.
Physiotherapy: Daily physiotherapy for 15 minutes with an inspiratory threshold
device. Supervised physiotherapy with walking, cycling and muscle training two
times a week two hours in the AtriumMC. A single referral to the smoking
cessation outpatient department when necessary. Check up with twice a long
function investigation and mouth pressure measurement, weekly muscle force
measurements.
Psychology: Before chemo and/or radiotherapy starts, patients will visit the
psycologist. After neoadjuvant therapy they will get a prolonged intake where
questionnaires regarding complaints, quality of life, anxiety and depression
will be filled out. On a daily basis patients will perform visualization
exercises with the use of a relaxation therapy CD. When necessary, patients
will receive a consult every two weeks.
Study burden and risks
This research is moderately aggravating for patients. Time investment needs to
be made and it might take some physical effort. There are no known risks for
this research.
henri dunantstraat 5
6401 CX Heerlen
Nederland
henri dunantstraat 5
6401 CX Heerlen
Nederland
Listed location countries
Age
Inclusion criteria
patients (>18 year) with esophageal cancer who will undergo esophaguscardiaresction after neoadjuvant therapy
Exclusion criteria
lack of 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 | NL25857.096.08 |