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Preoperative training for patients with esophageal cancer who will undergo resection.


- candidate number5920
- NTR NumberNTR1852
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2009
- Secondary IDs08T79 
- Public TitlePreoperative training for patients with esophageal cancer who will undergo resection.
- Scientific TitlePreconditioning for patients who will undergo esophaguscardiaresection, a PILOT-RCT.
- ACRONYMPC-OCR
- hypothesisDoes preconditioning prior to an esophaguscardiaresection result in enhanced mental state, cardiopulmonairy condition and nutritional status.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer, Esophagealcardiaresection
- Inclusion criteriaPatients (>18 year) with esophageal cancer who will undergo esophaguscardiaresction after neoadjuvant therapy.
- Exclusion criteriaLack of informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 11-jun-2009
- planned closingdate11-jun-2010
- Target number of participants20
- InterventionsNutrition:
Weekly consults consisting of nutritional assessment, MUST score, 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. A 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 inspiratory muscle force measurements.

Psychology:
Proceeding chemo and/or radiotherapy 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.
- Primary outcome1. Scores on QoL and anxiety and depression questionnaires;
2. Lungfunctiontests;
3. (Inspiratory) muscle force measurements;
4. BMI;
5. MUST-score;
6. Nutritional status.
- Secondary outcome1. Complications;
2. Morbidity;
3. Days on ICU;
4. Hospital length of stay;
5. Re-admission and mortality.
- Timepoints1. At time of diagnosis;
2. After neoadjuvant therapy;
3. Before operation.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr M. Sosef
- CONTACT for SCIENTIFIC QUERIESDr M. Sosef
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsnone
- Brief summaryBackground of the study:
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, the esophaguscardiaresections (OCR) of Southern Limburg are situated at AtriumMC, Heerlen. On yearly basis an amount of 40-45 patients is expected.

Objective of the study:
The purpose of this research is to investigate the effect 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.

Study population:
Patients with esophaguscardia cancer who will be indicated for esophaguscardiaresection during the meeting of oncology. This implicates both the adeno- or squamouscellcarcinoma.

Intervention (if applicable):
Nutrition: weekly consults consisting of nutritional assessment, MUST score, 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. A 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 inspiratory muscle force measurements.
Psychology: Proceeding chemo and/or radiotherapy 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.

Primary study parameters/outcome of the study:
Scores on the questionnaires, long function, (inspiratory) muscle force measurements, mound pressure measurements, BMI, force in the hand.

Secundary study parameters/outcome of the study (if applicable):
Complications, hospital length of stay, re-admission and mortality.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
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.
- Main changes (audit trail)
- RECORD11-jun-2009 - 30-sep-2009


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