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


- candidate number12070
- NTR NumberNTR3351
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-mrt-2012
- Secondary IDs11-T-86 METC atrium-orbis zuid
- Public TitlePreoperative training for patients with esophageal cancer who will undergo resection.
- Scientific TitlePreconditioning in patients undergoing esophaguscardiaresection.
- ACRONYMPC-OCR II
- hypothesisEarly multimodal preconditioning for patients who will undergo esophaguscardiaresection will lead to improvement of cardiorespiratory fitness, nutritional status and quality of life. This comes with improvement of postoperative morbidity and mortality.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer, Esophagealcardiaresection
- Inclusion criteriaPatients (> age 18) with esophageal carcinoma, who will have resection after neoadjuvant therapy.
- Exclusion criteriaAbsence of a signed informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate1-feb-2014
- Target number of participants76
- InterventionsNutrition:
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.
- Primary outcome1. 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.
- Secondary outcome1. Postoperative complications;
2. Length of hospital stay;
3. Length of stay on intensive care unit;
4. Mortality;
5. Re-admission.
- Timepoints1. Before neoadjuvant therapy;
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 Atrium Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medical Center, Heerlen
- PublicationsN/A
- 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%. 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.

Objective of the study:
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.

Study population:
Patients with esophaguscardiacancer or gastric cancer who will be indicated for esophaguscardiaresection during the multdisciplinary oncology meeting. This resection will be preceded by neoadjuvant therapy.

Intervention:
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 controlgroup will be subject to measurements three times during the preconditioning path. This will be done before and after neoadjuvant therapy and shortly before surgery.

Primary study parameters/outcome of the study:
1. Cardiorespiratory fitness: Consisting of VO2 max measurement, spirometry lungfunction and mouthpressure;
2. Nutritional status;
3. BMI;
4. Weight;
5. Muscleforce of the hand, triceps and quadriceps;
6. MUST score;
7. Nutritional Risk Index and Instant Nutritional Assesment;
7. Quality of Life measured with the EORTC QLQ-C30 and OES18 questionnaires.

Secundary study parameters/outcome of the study:
1. Postoperative complications;
2. Length of hospital stay;
3. Length of stay on intensive care unit;
4. Mortality;
5. Re-admission.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
- Main changes (audit trail)
- RECORD16-mrt-2012 - 29-mrt-2012


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