UndernourishedPENDICOQNCT03670199
Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program.
A study testing Dietary advice, Physiotherapist intervention and Dietary intervention in people with Undernourished and Digestive Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undernourished, Digestive Cancer
- What is being tested?
- Dietary advice, Physiotherapist intervention and Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2019to 28 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Interne et Nutrition, Hôpital de Hautepierre, Hôpitaux universitaires de Strasbourg
Strasbourg, 67098
Alain PRADIGNAC, MD, 33.3.88.12.75.89, alain.pradignac@chru-strasbourg.fr
Jean-François MUNIER, 33.3.88.12.79.69, Jeanfrancois.munier@chru-strasbourg.fr
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Undernourished, Digestive Cancer
- Being tested
- Dietary advice, Physiotherapist intervention, Dietary intervention, Intensify physiotherapist intervention
- Medical subject headings
- Malnutrition, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary adviceOther
Nutritional status assessment Explanation of standard nutritional advices with an written explanation sheet
Physiotherapist interventionOther
Respiratory capacity Functional capacity
Dietary interventionOther
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
Intensify physiotherapist interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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 Receives: Other: Dietary intervention; Other: Intensify physiotherapist intervention |
| Control group | Active comparator | usual preoperative advice for patients who undergoing surgical procedure concerning nutritional cares and physical activity Receives: Other: Dietary advice; Other: Physiotherapist intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the Medical Outcome Study Short Form 36 score
Use of a scale for quality of life
Measured: Change in score at 30 days before surgery and 1 Day before hospital discharge
Secondary outcomes (8)
Sarcopenia index measurement
Measure from routine preoperative Computerized Tomography scan
Measured: 30 days before surgery
Satisfaction score of the Nutrimus tool
Use of a questionnaire
Measured: 6 months postoperative
Ease of use of the Nutrimus tool
Use of a questionnaire
Measured: 6 months postoperative
Measurement of the Medical Outcome Study Short Form 36 score
Use of a scale for quality of life
Measured: Change in score at 1 day before surgery, 1 day before the end of hospitalization, 1 Month, 3 Months and 6 Months post hospitalization
Evaluation of nutritional parameters
Use of a notebook
Measured: 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
Evaluation of respiratory and functional capacities
Measured: 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
Pain assessment
Use of a visual analogue scale Measure of score from 0 to 10
Measured: 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
Length hospitalization
Length (in days) between hospital admission and discharge
Measured: Duration (in days) of patient's hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start29 Jan 2019
- Primary completion28 Apr 2024 (estimated)
- Study completion28 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernourishedStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain PARDIGNAC, Principal investigator, Strasbourg Universitary hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670199
- Sponsor's protocol ID
- 6117
- Acronym
- PENDICOQ
- Status last verified
- Sep 2021
- First submitted
- 11 Jul 2018
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Life of Cancer Patients Through a Perioperative and Coordinated Nutrition and Physical Care Program.
- ClinicalTrials.gov ID
- NCT03670199
- Acronym / sponsor ID
- PENDICOQ / 6117
- Conditions
- Undernourished, Digestive Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 28 Apr 2024 (estimated)
- Study completion
- 28 Apr 2024 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Dietary intervention, Other: Intensify physiotherapist interventionnutritional 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 |
| Control group | Active comparator | Other: Dietary advice, Other: Physiotherapist interventionusual preoperative advice for patients who undergoing surgical procedure concerning nutritional cares and physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary adviceNutritional status assessment Explanation of standard nutritional advices with an written explanation sheet | Other | Control group |
| Physiotherapist interventionRespiratory capacity Functional capacity | Other | Control group |
| Dietary interventionNutritional 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 | Experimental group |
| Intensify physiotherapist interventionRespiratory 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 | Other | Experimental group |
Primary outcome
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
8 secondary outcomes
Sarcopenia index measurement
Time frame: 30 days before surgery
Satisfaction score of the Nutrimus tool
Time frame: 6 months postoperative
Ease of use of the Nutrimus tool
Time frame: 6 months postoperative
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
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
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
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
Length hospitalization
Time frame: Duration (in days) of patient's hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain PARDIGNAC principal investigator
Strasbourg Universitary hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary advice, Physiotherapist intervention and Dietary intervention in people with Undernourished and Digestive Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DRCI Strasbourg (0388117438, dpidrci@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.