Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program. (PENDICOQ)

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Digestive Cancer; Undernourished

Treatments: Other: Intensify physiotherapist intervention; Other: Dietary intervention; Other: Physiotherapist intervention; Other: Dietary advice

Study type: Interventional

Funder types: Other

Identifiers

NCT03670199

6117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Experimental group

Experimental group

Description:

nutritional and functional management coordinated by dieticians and physiotherapists, with adapted nutritional and physical advice and support, realized with the use of Nutrimus booklet in order to facilitate coordination and delivration of cares proposed to the patients

Treatment:

Other: Dietary intervention

Other: Intensify physiotherapist intervention

Control group

Active Comparator group

Description:

usual preoperative advice for patients who undergoing surgical procedure concerning nutritional cares and physical activity

Treatment:

Other: Physiotherapist intervention

Other: Dietary advice