MalnutritionPhase 3NCT02664974
Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer
A Phase 3 study testing Enteral nutrition and Dietary counseling in people with Malnutrition and Gastrointestinal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
Trial summary
Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial. The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Gastrointestinal Cancer
- What is being tested?
- Enteral nutrition and Dietary counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2008to Jun 2011
- Phase
- Phase 3
- 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
- Both gender with age higher than 18 years.
- Documented cancer of the gastrointestinal tract: oesophagus, stomach, pancreas, biliary tract
- Candidate for major elective surgery.
- Preoperative nutritional risk score ≥ 3
- Written informed consent.
Who cannot join
- Age < 18 years
- Karnofsky index < 60
- Renal insufficiency (Ongoing haemodialysis or plasma creatinine > 3 mg/dL)
- Respiratory insufficiency
- Child-Pugh class C
- Short Bowel Syndrome
Show all 9Show fewer
- Pregnancy
- Emergency operation
- Foreign residence or residence in Italian region with no regulation designed for home artificial nutrition
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
European Institute of Oncology
Milan, Milan, 20100
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milan, 20133
About this study
Official title: Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer: A Multicenter Randomized Clinical Trial
Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial.
The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach, pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition (HEN, treatment group) or nutritional counselling (control group).
- Conditions
- Malnutrition, Gastrointestinal Cancer
- Being tested
- Enteral nutrition, Dietary counseling
- 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.
Enteral nutritionDietary supplement
Home Enteral Nutrition was planned to cover the basal energy requirement calculated with Harris Benedict Formula, it was administrated preferentially during nocturnal hours as an integration of oral diet.
Enteral Nutrition included any standard polymeric formula providing 1-1.5 Kcal/mL with carbohydrates 50%-60%, lipids 25%-35% and protein 12%-20%.
Home Enteral Nutrition can be withdrawn in the treated group, after 2 months from discharge, whenever a weight gain ≥ 5% is reported, and oral alimentation is regular and adequate.
Dietary counselingOther
Specific nutritional advices including total energy and protein requirements were provided to patients and oral high-calorie supplements were prescribed whenever necessary.
Home Enteral Nutrition can be started in patients of the control group, not before two months from discharge, if a further weight loss ≥ than 5% is reported.
| Study group | Role | What they receive |
|---|---|---|
| HEN group | Experimental | Home Enteral Nutrition Receives: Dietary Supplement: Enteral nutrition |
| Control group | Active comparator | Dietary Counseling Receives: Other: Dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of body weight
Evaluated by weight change after discharge
Measured: 2 months
Secondary outcomes (2)
Improvement of quality of life
Evaluated at hospital admission and two months after discharge by the self-administrated Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
Measured: 2 months
Improvement of tolerance to chemotherapy
Evaluated by the ratio chemotherapy planned / chemotherapy administered
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startDec 2008
- Primary completionFeb 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Gavazzi, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664974
- Sponsor's protocol ID
- HEN
- Status last verified
- Jan 2016
- First submitted
- 13 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02664974
- Acronym / sponsor ID
- HEN
- Conditions
- Malnutrition, Gastrointestinal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Jan 2016 (estimated)
- 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.
Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial.
The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach, pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition (HEN, treatment group) or nutritional counselling (control group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEN group | Experimental | Dietary Supplement: Enteral nutritionHome Enteral Nutrition |
| Control group | Active comparator | Other: Dietary counselingDietary Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both gender with age higher than 18 years.
- Documented cancer of the gastrointestinal tract: oesophagus, stomach, pancreas, biliary tract
- Candidate for major elective surgery.
- Preoperative nutritional risk score ≥ 3
- Written informed consent.
Key exclusion criteria (9 listed)
- Age < 18 years
- Karnofsky index < 60
- Renal insufficiency (Ongoing haemodialysis or plasma creatinine > 3 mg/dL)
- Respiratory insufficiency
- Child-Pugh class C
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 |
|---|---|---|
| Enteral nutritionHome Enteral Nutrition was planned to cover the basal energy requirement calculated with Harris Benedict Formula, it was administrated preferentially during nocturnal hours as an integration of oral diet. Enteral Nutrition included any standard polymeric formula providing 1-1.5 Kcal/mL with carbohydrates 50%-60%, lipids 25%-35% and protein 12%-20%. Home Enteral Nutrition can be withdrawn in the treated group, after 2 months from discharge, whenever a weight gain ≥ 5% is reported, and oral alimentation is regular and adequate. | Dietary supplement | HEN group |
| Dietary counselingSpecific nutritional advices including total energy and protein requirements were provided to patients and oral high-calorie supplements were prescribed whenever necessary. Home Enteral Nutrition can be started in patients of the control group, not before two months from discharge, if a further weight loss ≥ than 5% is reported. | Other | Control group |
Primary outcome
Maintenance of body weight
Time frame: 2 months
Evaluated by weight change after discharge
2 secondary outcomes
Improvement of quality of life
Time frame: 2 months
Improvement of tolerance to chemotherapy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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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.
Cecilia Gavazzi, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enteral nutrition and Dietary counseling in people with Malnutrition and Gastrointestinal Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of body weight (time frame: 2 months). 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 27 Jan 2016.