Clinical trial NCT03670199: Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program.
Official title: Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Undernourished
Digestive Cancer
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hospitalization, for cancer patients, exposes to a risk of undernutrition which has the effect of significantly increasing infections, pressure ulcers, muscle wasting, loss of autonomy, impaired function and delayed healing.

All of these factors contribute to increase the length of stay in hospital, thus lengthening the spiral of undernutrition, which has serious consequences for the patient welbeing, health establishments and public health.

Undernutrition has been the subject of many studies over the last twenty years, that outline that an adequate nutritional management exerts a direct effect on the reduction of comorbidities and duration of hospitalization.

However, there are periods, in the preoperative course of care, where nutritional and phisical care are not realized in the current clinical practice whereas they could be done, for example, between the diagnosis and the consultation of anesthesia, between the anesthesia consultation and the surgical procedure and the end of hospitalization of the patient.

Current management is usually limited to the period of hospitalization which tends to be reduced. This situation is reinforced by the absence of relays at home, dietary consultations being not reimbursed by French health insurance.

Moreover, a preliminary survey, conducted in 2012 during the pre-operative outpatient anesthesia consultation, shows that 26% of patients are already clinically malnourished, with 16.5 % of them who have lost more than 10% of their weight.

Detailed description: Then, the investigators hypothesize that the combination of perioperative nutrition and mobilization program coordinated andrealized by dieticians and physiotherapists, with the Nutrimus follow-up booklet, would improve the post-operative evolution of patients and reduce their postoperative comorbidities.

This management, initiated at the consultation of anesthesia, would include an accurate nutritional diagnosis, nutritional and physical support therapy to improve their nutritional and muscular status.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years old
* Patient with Karnofsky index superior or equal to 60%.
* Patient with cancer of the following digestive tract: peritoneal carcinoma, sarcoma, pancreas, rectum, esophagus, stomach diagnosed or under diagnosis
* Patient admitted for a scheduled surgery at least 10 days after a preoperative consultation
* Patient affiliated to a social health insurance scheme
* Patient having dated and signed an informed consent
* Patient having been informed of the results of the prior medical examination

Exclusion Criteria:

* Inhospital patients
* Patient admitted in emergency
* Impossibility of giving the patient information (alteration of patient's cognitive function)
* Illiteracy or dyscalculia
* Patients protected (guardianship, curatorship, safeguard of justice)
* Pregnancy, breastfeeding
* Subject in exclusion period (determined by a previous or ongoing study),
* Patient included in another ongoing clinical trial
* Patient with neuro-endocrine cancer
* Patient reoperated for the same pathology

Primary outcomes:
measure: Variation of the Medical Outcome Study Short Form 36 score
timeFrame: Change in score at 30 days before surgery and 1 Day before hospital discharge
Secondary outcomes:
measure: Sarcopenia index measurement
timeFrame: 30 days before surgery
measure: Satisfaction score of the Nutrimus tool
timeFrame: 6 months postoperative
measure: Ease of use of the Nutrimus tool
timeFrame: 6 months postoperative
measure: Measurement of the Medical Outcome Study Short Form 36 score
timeFrame: Change in score at 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
measure: Evaluation of nutritional parameters
timeFrame: Change in values measures at 30 days to 10 days, 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
measure: Evaluation of respiratory and functional capacities
timeFrame: Change in measures at 30 days to 10 days, 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
measure: Pain assessment
timeFrame: Change in score at 30 days to 10 days, 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
measure: Length hospitalization
timeFrame: Duration (in days) of patient's hospitalization
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
Study officials:
affiliation: Strasbourg Universitary hospitals
name: Alain PARDIGNAC
role: PRINCIPAL_INVESTIGATOR
References: