Primary NeoplasmPhase 4NCT01894828
Nutritional Supplementation in Patients With no Signs of Malnutrition
A Phase 4 study testing Nutritional supplements in people with Primary Neoplasm and Secondary Neoplasm, run by MedSource Polska at 1 site in Poland.
Trial summary
The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Neoplasm, Secondary Neoplasm, Abdominal Neoplasm
- What is being tested?
- Nutritional supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2011to Aug 2013
- Phase
- Phase 4
- 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
- Primary or secondary resectable gastrointestinal and abdominal malignancy
- No signs of malnutrition at qualification for surgery
- General performance >70 Karnofsky scale
- Informed consent
Who cannot join
- history of radio or chemotherapy
- signs of mechanical ileus
- other major gastrointestinal diseases
- type 1 diabetes
- autoimmunological diseases requiring systemic steroids
- signs of infection
- renal and/or liver failure
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Surgical Oncology Medical University of Gdańsk
Gdansk, Pomeranian Voivodeship, 80-210
Paweł Kabata, MD, +48509707959, pawel.kabata@gmail.com
Paweł Kabata, MD
About this study
Official title: The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition
The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition
Read the detailed description
In previous psychological studies our team found high level psychological stress in over 60% of cancer patients. This may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. In this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications
- Conditions
- Primary Neoplasm, Secondary Neoplasm, Abdominal Neoplasm
- Being tested
- Nutritional supplements
- Keywords
- Nutritional support, Gastrointestinal cancer, Malnutrition
- Medical subject headings
- Neoplasm Metastasis, Abdominal Neoplasms, Gastrointestinal Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementsDietary supplement
Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplements | Active comparator | Patients are asked to drink two 200ml bottles of nutritional supplement daily Receives: Dietary Supplement: Nutritional supplements |
| Control | No intervention | Patients are asked to keep on to their normal diet. No supplementation is introduced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of nutritional status
The aim of the study was to assess if nutritional supplementation improves nutritional status of patients with no clinical signs of malnutrition. Nutritional status improvement will be assessed by change in anthropometric (body weight (kg)) and laboratory (albumin, total protein, transferrin level, total lymphocyte count) parameters.
Measured: After 14 days
Secondary outcomes (1)
Reducing number of complications
To assess if improvement of nutritional status is connected with reduced number of postoperative complications.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startApr 2011
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary NeoplasmStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedSource Polska
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paweł Kabata, MD, Principal investigator, Department of Surgical Oncology Medical University of GdańskTomasz Jastrzębski, Prof., Study director, Department of Surgical Oncology Medical University of Gdańsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894828
- Sponsor's protocol ID
- Nutri01
- Status last verified
- Jul 2013
- First submitted
- 4 Jul 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition
- ClinicalTrials.gov ID
- NCT01894828
- Acronym / sponsor ID
- Nutri01
- Conditions
- Primary Neoplasm, Secondary Neoplasm, Abdominal Neoplasm
- Keywords
- Nutritional support, Gastrointestinal cancer, Malnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MedSource PolskaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2013 (estimated)
- First posted
- 10 Jul 2013 (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.
The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition
Detailed description
In previous psychological studies our team found high level psychological stress in over 60% of cancer patients. This may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. In this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplements | Active comparator | Dietary Supplement: Nutritional supplementsPatients are asked to drink two 200ml bottles of nutritional supplement daily |
| Control | No intervention | –Patients are asked to keep on to their normal diet. No supplementation is introduced |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary or secondary resectable gastrointestinal and abdominal malignancy
- No signs of malnutrition at qualification for surgery
- General performance >70 Karnofsky scale
- Informed consent
Key exclusion criteria (7 listed)
- history of radio or chemotherapy
- signs of mechanical ileus
- other major gastrointestinal diseases
- type 1 diabetes
- autoimmunological diseases requiring systemic steroids
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 |
|---|---|---|
| Nutritional supplementsPatients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery | Dietary supplement | Nutritional supplements |
Primary outcome
Improvement of nutritional status
Time frame: After 14 days
The aim of the study was to assess if nutritional supplementation improves nutritional status of patients with no clinical signs of malnutrition. Nutritional status improvement will be assessed by change in anthropometric (body weight (kg)) and laboratory (albumin, total protein, transferrin level, total lymphocyte count) parameters.
1 secondary outcome
Reducing number of complications
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
Related trials for Primary Neoplasm
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
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.
Paweł Kabata, MD principal investigator
Department of Surgical Oncology Medical University of Gdańsk
Tomasz Jastrzębski, Prof. study director
Department of Surgical Oncology Medical University of Gdańsk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutritional supplements in people with Primary Neoplasm and Secondary Neoplasm, run by MedSource Polska at 1 site in Poland.
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 4 inclusion and 7 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 10 Jul 2013. 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 Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Paweł Kabata, MD (+48509707959, pawel.kabata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of nutritional status (time frame: After 14 days). 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 10 Jul 2013.