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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR3351 |
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Date of registration:
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16/03/2012 |
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Primary sponsor: |
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Public title:
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Preoperative training for patients with esophageal cancer who will undergo resection.
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Scientific title:
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Preconditioning in patients undergoing esophaguscardiaresection. - PC-OCR II |
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Date of first enrolment:
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1/2/2012 |
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Target sample size:
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76 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3351 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.
Sosef |
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Address:
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Atrium MC Heerlen
Chirurgie, Postbus 4446
6401 CX
Heerlen
The Netherlands |
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Telephone:
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+31 45 576 66 66 |
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Email:
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meindert.sosef@planet.nl |
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Affiliation:
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Name:
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M.
Sosef |
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Address:
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Atrium MC Heerlen
Chirurgie, Postbus 4446
6401 CX
Heerlen
The Netherlands |
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Telephone:
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+31 45 576 66 66 |
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Email:
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meindert.sosef@planet.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients (> age 18) with esophageal carcinoma, who will have resection after neoadjuvant therapy.
Exclusion criteria: Absence of a signed informed consent.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Esophageal cancer, Esophagealcardiaresection
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Intervention(s)
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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 control group will receive care as usual.
The intervention will take 13 weeks in total.
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Primary Outcome(s)
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1. VO2 max;
2. Spirometry lungfunction;
3. Muthpressure;
4. BMI;
5. Weight;
6. Muscleforce of the hand, triceps and quadriceps;
7. MUST score;
8. Nutritional Risk Index and Instant Nutritional Assesment;
9. Quality of Life measured with the EORTC QLQ-C30 and OES18 questionnaires.
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Secondary Outcome(s)
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1. Postoperative complications;
2. Length of hospital stay;
3. Length of stay on intensive care unit;
4. Mortality;
5. Re-admission.
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Source(s) of Monetary Support
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Atrium Medical Center, Heerlen
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