Postoperative ComplicationsBC1NCT05068882
Impact of Oral Diets on Postoperative Fluid Collection
A study testing Immunonutrition, High-protein nutrition and Standard nutrition in people with Postoperative Complications, run by Stanley Dudrick's Memorial Hospital at 2 sites in Poland.
Trial summary
Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Immunonutrition, High-protein nutrition and Standard nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jun 2021to 31 Mar 2023
- 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
- confirmed breast cancer or melanoma
- scheduled surgery with axillary lymph nodes resection
- informed consent
- eligible for surgery
Who cannot join
- benign disease
- no consent
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Maria Sklodowska-Curie National Cancer Institute
Krakow, Malopolska, 31-115
Narodowy I Onkologii, 60293566, stanislaw.klek@onkologia.krakow.pl
- Recruiting
Stanley Dudrick's Memorial Hospital
Skawina, 32-050
Stanislaw Klek, Assoc. Prof., +48604293566, klek@poczta.onet.pl
Stanislaw Klek, Assoc. Prof.
About this study
Official title: Impact of Preoperative Oral Diets on Postoperative Fluid Collection After Axillary Lymphadenectomy
Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.
Read the detailed description
Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections, which requires either prolonged drainage or multiple punctuations. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.
- Conditions
- Postoperative Complications
- Being tested
- Immunonutrition, High-protein nutrition, Standard nutrition
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunonutritionDietary supplement
Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
High-protein nutritionDietary supplement
Oral nutrition with high-protein content
Standard nutritionDietary supplement
Oral nutrition with standard ingredients
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition | Experimental | Oral immunonutrition containing arginine, omega-PUFAs and antioxidants Receives: Dietary Supplement: Immunonutrition |
| High-protein diet | Active comparator | Oral nutrition with high-protein content Receives: Dietary Supplement: High-protein nutrition |
| Standard nutrition | Active comparator | Oral nutrition with standard ingredients Receives: Dietary Supplement: Standard nutrition |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid collection
The volume of fluid collection after lymph nodes resection expressed in mililiters
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 posted6 Oct 2021
- Study start1 Jun 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 arm randomized study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanley Dudrick's Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislaw Klek, Stanley Dudrick's Memorial Hospital
- Investigators
- Stanislaw Klek, PhD, Principal investigator, Stanley Dudrick's Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068882
- Sponsor's protocol ID
- BC1
- Acronym
- BC1
- Status last verified
- Oct 2021
- First submitted
- 25 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Oral Diets on Postoperative Fluid Collection After Axillary Lymphadenectomy
- ClinicalTrials.gov ID
- NCT05068882
- Acronym / sponsor ID
- BC1 / BC1
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Stanley Dudrick's Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 6 Oct 2021 (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.
Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.
Detailed description
Patients after the surgical removal of axillary lymphnodes suffers from prolonged fluid collections, which requires either prolonged drainage or multiple punctuations. The aim of the study is to assess the impact of oral immunonutrition and high-protein diets on the reduction of fluid collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 arm randomized study
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition | Experimental | Dietary Supplement: ImmunonutritionOral immunonutrition containing arginine, omega-PUFAs and antioxidants |
| High-protein diet | Active comparator | Dietary Supplement: High-protein nutritionOral nutrition with high-protein content |
| Standard nutrition | Active comparator | Dietary Supplement: Standard nutritionOral nutrition with standard ingredients |
| No intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed breast cancer or melanoma
- scheduled surgery with axillary lymph nodes resection
- informed consent
- eligible for surgery
Key exclusion criteria (2 listed)
- benign disease
- no consent
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 |
|---|---|---|
| ImmunonutritionOral immunonutrition containing arginine, omega-PUFAs and antioxidants | Dietary supplement | Immunonutrition |
| High-protein nutritionOral nutrition with high-protein content | Dietary supplement | High-protein diet |
| Standard nutritionOral nutrition with standard ingredients | Dietary supplement | Standard nutrition |
Primary outcome
Fluid collection
Time frame: 6 months
The volume of fluid collection after lymph nodes resection expressed in mililiters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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.
Stanislaw Klek, PhD principal investigator
Stanley Dudrick's Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrition, High-protein nutrition and Standard nutrition in people with Postoperative Complications, run by Stanley Dudrick's Memorial Hospital at 2 sites 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 2 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 Oct 2021. 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 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.
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 Stanislaw Klek, PhD (+48604293566, klek@poczta.onet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid collection (time frame: 6 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 13 Oct 2021.