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Trial record 53 of 6682 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

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ClinicalTrials.gov Identifier: NCT03670199
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Undernourished Digestive Cancer Other: Dietary advice Other: Physiotherapist intervention Other: Dietary intervention Other: Intensify physiotherapist intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program.
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : April 28, 2024
Estimated Study Completion Date : April 28, 2024

Arm Intervention/treatment
Experimental: Experimental group
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
Other: Dietary intervention
Nutritional status assessment Presentation of the Nutrimus booklet by the coordinating dietitian Establishment or adaptation of a nutritional support (prescription of nutritional supplements if necessary). Delivery and explanation of the preoperative nutritional counseling support

Other: Intensify physiotherapist intervention
Respiratory capacity Functional capacity Tips adapted for physical activity and strengthening or maintenance of muscle mass Presentation of respiratory physiotherapy exercises to prevent postoperative bronchial congestion Nutrition and physical mobilization tips with the Nutrimus booklet

Active Comparator: Control group
usual preoperative advice for patients who undergoing surgical procedure concerning nutritional cares and physical activity
Other: Dietary advice
Nutritional status assessment Explanation of standard nutritional advices with an written explanation sheet

Other: Physiotherapist intervention
Respiratory capacity Functional capacity




Primary Outcome Measures :
  1. Variation of the Medical Outcome Study Short Form 36 score [ Time Frame: Change in score at 30 days before surgery and 1 Day before hospital discharge ]
    Use of a scale for quality of life


Secondary Outcome Measures :
  1. Sarcopenia index measurement [ Time Frame: 30 days before surgery ]
    Measure from routine preoperative Computerized Tomography scan

  2. Satisfaction score of the Nutrimus tool [ Time Frame: 6 months postoperative ]
    Use of a questionnaire

  3. Ease of use of the Nutrimus tool [ Time Frame: 6 months postoperative ]
    Use of a questionnaire

  4. Measurement of the Medical Outcome Study Short Form 36 score [ Time Frame: Change in score at 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization ]
    Use of a scale for quality of life

  5. Evaluation of nutritional parameters [ Time Frame: 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 ]
    Use of a notebook

  6. Evaluation of respiratory and functional capacities [ Time Frame: 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 ]
  7. Pain assessment [ Time Frame: 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 ]
    Use of a visual analogue scale Measure of score from 0 to 10

  8. Length hospitalization [ Time Frame: Duration (in days) of patient's hospitalization ]
    Length (in days) between hospital admission and discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient ≥ 18 years old
  • Patient with Karnofsky index superior or equal to 60%.
  • Patient with cancer of the aero-digestive and / or mesocolic gastrointestinal tract (pancreas, colon, esophagus, stomach) diagnosed or in course of 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670199


Contacts
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Contact: DRCI Strasbourg 0388117438 dpidrci@chru-strasbourg.fr

Locations
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France
Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Alain PRADIGNAC, MD    33.3.88.12.75.89    alain.pradignac@chru-strasbourg.fr   
Contact: Jean-François MUNIER    33.3.88.12.79.69    Jeanfrancois.munier@chru-strasbourg.fr   
Principal Investigator: Alain PRADIGNAC, MD         
Sub-Investigator: Serge ROHR, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Alain PARDIGNAC Strasbourg Universitary hospitals

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03670199     History of Changes
Other Study ID Numbers: 6117
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No