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Cancer-related MalnutritionPhase 4NCT03355079

Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy

A Phase 4 study testing SmofKabiven® E in people with Cancer-related Malnutrition, run by Fresenius Kabi at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the efficacy of long-term addition of SmofKabiven® E to normal oral nutrition after routine dietary counseling as compared to standard of care nutrition in which oral nutrition is the primary nutritional support. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer-related Malnutrition
What is being tested?
SmofKabiven® E
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteFrance
Study dates
28 Feb 2018to 5 Apr 2019
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

  • Metastatic non-small cell lung cancer patient
  • Adult ≥ 18 years
  • Starting any 1st, 2nd or 3rd line chemotherapy and/or immunotherapy administered via a central venous catheter (including implanted ports), or receiving the 2nd cycle of aforementioned anticancer treatment
  • An energy gap of ≥ 40 % and/or 1000 kcal between the target energy intake (30 ± 5 kcal/kg/day) and the actual energy intake at screening, irrespective of weight loss
  • Functional digestive tract allowing oral intake
  • If female of childbearing potential, willing to use a sufficiently safe contraception method throughout participation in the study
  • Signed informed consent from patient or legal representative

Who cannot join

  • Parenteral nutrition (PN) administered during the preceding month (the sole administration of intravenous glucose is allowed), or standard of care PN planned to start within 3 weeks after baseline visit
  • More than 1600 kcal/day required as PN
  • Tube feeding at screening, or planned to start within 3 weeks after baseline visit
  • Body mass index (BMI) > 30 kg/m2
  • Performance status > 3 Eastern Cooperative Oncology Group (ECOG) score
  • Life expectancy < 3 months
Show all 22Show fewer
  • Active bloodstream infection demonstrated by positive blood culture at Screening
  • Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients in SmofKabiven E
  • Severe blood coagulation disorders
  • Congenital errors of amino acid metabolism
  • Pathologically elevated serum levels of any of the included electrolytes
  • General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
  • Hemophagocytotic Syndrome
  • Severe hyperlipidemia (serum triglycerides > 353 mg/dL)
  • Severe liver insufficiency: liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyl transferase [GGT]) or conjugated bilirubin exceeding 3 x upper limit of normal range, or International Normalised Ratio (INR) > 2
  • Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m2) and patients on renal replacement therapy
  • Uncontrolled hyperglycaemia
  • Unstable conditions (e.g., embolism, metabolic acidosis, hypotonic dehydration)
  • Pregnancy or lactation
  • Contraindications to any of the study assessment methods including computer tomography and indirect calorimetry
  • Participation in a clinical study with an investigational drug or investigational medical device within one month prior to start of study or during study
  • Prior inclusion in the present study

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Cochin

    Paris, 75014

Other trials in France

About this study

Official title: Efficacy of Long-term Parenteral Nutrition With SmofKabiven® E Concomitant to Chemo- and/or Immunotherapy: A Prospective, Randomised, Controlled, Open, Multicentre, Two-stage, Adaptive Clinical Trial in Metastatic Non-small Cell Lung Cancer

The purpose of this study is to determine the efficacy of long-term addition of SmofKabiven® E to normal oral nutrition after routine dietary counseling as compared to standard of care nutrition in which oral nutrition is the primary nutritional support. It takes place in lung cancer patients under chemo- and/or immunotherapy. Efficacy will be determined primarily by calculating the change of patient's body weight from before start of study treatment to end of treatment, and comparing this change between both treatment groups.

Being tested
SmofKabiven® E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmofKabiven® EDrug

    In the intervention arm, SmofKabiven® E, with or without addition of Suppliven®, Vitalipid® Adult and/or Soluvit®, will be administered in addition to standard of care oral nutrition as per dietary counseling, whereas in the control arm, oral nutrition as per dietary counseling is the primary nutritional support.

Study groups in NCT03355079
Study groupRoleWhat they receive
SmofKabiven® E + standard oral nutritionExperimentalSmofKabiven® E, with or without addition of Suppliven®, Vitalipid® Adult and/or Soluvit® will be administered at 5-7 days per week for up to 9 +/-1 weeks in addition to standard of care oral nutrition as per routine dietary counseling, to reach the patient's target energy intake.
Receives: Drug: SmofKabiven® E
Standard oral nutritionNo interventionThe patients will consume standard of care oral nutrition as per routine dietary counseling, to reach their target energy intake. Standard of care tube feeding or parenteral nutrition is allowed to start earliest 3 weeks after baseline visit, if required.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in total body weight (kg)

    Measured: Every 2-3 weeks, for up to 9 +/-1 weeks

Secondary outcomes (23)

  1. Serum albumin

    Measured: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  2. Serum transthyretin

    Measured: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  3. Nutritional Risk Index

    Measured: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  4. Unplanned PN or tube feeding according to standard of care in control group

    Measured: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  5. Early termination of PN due to improvement in test group

    Measured: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  6. Lean body mass determined from computer tomography (CT) scan at 3rd lumbar vertebra

    Measured: Baseline to final visit at 9 +/1 weeks after baseline

  7. Optional: lean tissue mass, phase angle and hydration status including intra- and extracellular body water with bioelectrical impedance analysis (BIA), if BIA device is available.

    Measured: Baseline to final visit at 9 +/1 weeks after baseline

  8. Karnofsky performance status

    Measured: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  9. ECOG performance status

    Measured: Time Frame: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  10. Handgrip strength in kg, using hand dynamometer

    Measured: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  11. Actual and target number of completed chemotherapy and/or immunotherapy cycles

    Measured: Every 2-3 weeks from baseline to 3 months after baseline

  12. Actual dose and target chemotherapy and/or immunotherapy dose administered

    Measured: Every 2-3 weeks from baseline to 3 months after baseline

  13. Chemotherapy and/or immunotherapy toxicities according to NCI-CTC v4.0 including dose-limiting toxicities

    Measured: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  14. Fatigue using the brief fatigue inventory (BFI questionnaire)

    Measured: Every 2-3 weeks from baseline to final visit at 9 +/1 weeks after baseline

  15. Overall survival

    Measured: Until 6 months post baseline

  16. Progression-free survival

    Measured: At 3 and 6 months post baseline

  17. Partial response rate (as per RECIST v 1.1)

    Measured: At 9 +/-1 weeks, 3 months and 6 months after baseline

  18. Complete response rate (as per RECIST v 1.1)

    Measured: At 9 +/-1 weeks, 3 months and 6 months after baseline

  19. Unplanned hospitalization

    Measured: From baseline until 6 months after baseline

  20. Quality of life (Functional Assessment of Cancer Therapy- General [FACT-G] score)

    Measured: From baseline until final visit at 9 +/-1 weeks after baseline

  21. Number of patients terminating anti-cancer and nutrition therapy as part of end-of-life care

    Measured: From baseline until final visit at 9 +/-1 weeks after baseline

  22. Resting energy expenditure

    measured by indirect calorimetry

    Measured: From baseline until final visit at 9 +/-1 weeks after baseline

  23. Ocurrence of unplanned admission to nursing home

    Measured: From baseline until final visit at 9 +/-1 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2017
  2. Study start28 Feb 2018
  3. Primary completion5 Apr 2019
  4. Study completion5 Apr 2019

Why it stopped: Low Patient Recruitment

Resources

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03355079
Sponsor's protocol ID
SMKV-013-CP4
Status last verified
Apr 2019
First submitted
16 Nov 2017
Last updated
1 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SmofKabiven® E in people with Cancer-related Malnutrition, run by Fresenius Kabi 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 22 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: stopped early, as of the sponsor's last update on 1 May 2019. 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.

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?

The study was stopped early (reason given: Low Patient Recruitment). Results are not available in the source record.

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?

Change in total body weight (kg) (time frame: Every 2-3 weeks, for up to 9 +/-1 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03355079.

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 1 May 2019.

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