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AzTrials

Squamous Cell Carcinoma of the Hypopharynx Stage IIIPhase 3AGMT_HNO_PNNCT02236936

Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck

A Phase 3 study testing Parenteral over night nutrition, Cetuximab and Cisplatin in people with Squamous Cell Carcinoma of the Hypopharynx Stage III and Squamous Cell Carcinoma of the Hypopharynx Stage IV, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.

Terminated

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

Official record
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Trial summary

Prevention of critical weight loss. In patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) weight loss is a relevant clinical problem during radiotherapy and might result in higher treatment related toxicity and discontinuation of a potential curative treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Parenteral over night nutrition, Cetuximab and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
7 sitesAustria
Study dates
3 Feb 2017to 10 Jul 2019
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

  • Any patient who is eligible for definitive curative radio-chemotherapy with Cisplatin or radio-immunotherapy with Cetuximab.
  • Written informed consent obtained prior to any study specific screening activities and patients have to be able to comply with this protocol.
  • Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris treated with definitive radiotherapy in combination with Cisplatin or Cetuximab.
  • p16 status available
  • Age ≥ 18
  • Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception.

Who cannot join

  • Distant metastases
  • Prior radiation (Head and neck area)
  • Pregnant or lactating women
  • History of other malignancy; yet patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  • Concurrent other cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug.
  • Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent.
  • Participation in another interventional clinical study at time of study inclusion (except follow-up period without treatment for more than 30 days) or denial of the simultaneous participation in a non-interventional study by the PI of the study center.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Austria7 sites

  • Landeskrankenhaus Feldkirch

    Feldkirch, A-6807

  • Medizinische Universität Graz, HNO Universitätsklinik

    Graz, A-8036

  • Klinikum Klagenfurt am Wörthersee, HNO-Abteilung

    Klagenfurt, A-9020

  • Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie

    Linz, 4010

  • Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie

    Vienna, 1130

  • Hanuschkrankenhaus

    Vienna, 1140

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, 2700

Other trials in Austria

About this study

Official title: Randomized Phase III Study: Supplemental Parenteral Nutrition for Patients With Locally Advanced Inoperable Tumors of the Head and Neck, Receiving Definitive Radiotherapy With Cetuximab or Cisplatin

Prevention of critical weight loss. In patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) weight loss is a relevant clinical problem during radiotherapy and might result in higher treatment related toxicity and discontinuation of a potential curative treatment. Thus the investigators want to evaluate the efficacy of overnight parenteral nutritional (PN) support in patients with SCCHN treated with curative radiotherapy (RTX) in combination with Cetuximab (E) or Cisplatin (P).

Read the detailed description

The investigators hypothesize that about 60% of patients receiving RTX without supplemental PN will suffer from critical weight loss of more than 5% during treatment - supplemental overnight PN might result in significant improvement of the nutritional status .

Being tested
Standard care of parenteral nutrition, Parenteral over night nutrition, Cetuximab, Cisplatin, Radiotherapy
Keywords
Squamous Cell Carcinoma, Head and neck, SCCHN, Parenteral nutrition, Larynx, Hypopharynx, Cavum oris, Radiotherapy, Cetuximab, Cisplatin
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell, Hyperphagia, Laryngeal Diseases

What participants receive

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

  • Standard care of parenteral nutritionDietary supplement

    Also called PN

    Standard treatment according to the discretion of the center, any required nutritional support (enteral tube feeding by nasogastric tube or percutaneous endoscopic gastrostomy) when considered necessary is allowed

  • Parenteral over night nutritionDietary supplement

    Also called Emulsion for infusion

    Patients in interventional Arm B will receive parenteral overnight nutrition with ZentroOLIMEL® 5.7% with electrolytes, vitamins (Cernevit®) and micronutrients (Addel Trace® or Nutryelt®) starting with 15 ml/kg body weight/day. In case of weight loss of more than 5%, dose of ZentroOLIMEL® has to be increased up to 25 ml/kg/body weight/day.

  • CetuximabBiological

    Also called Erbitux

    Weekly during radiotherapy; not given if cisplatin is given during radiotherapy

    Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)

  • CisplatinDrug

    Also called Cisplatinum, CDDP

    Cisplatin total dose of >200 mg administered weekly (40 mg/m2/week) or every three weeks (100 mg/m2 every three weeks) according to local standard; not given in combination with cetuximab

  • RadiotherapyRadiation

    Also called RTX

    70 Gy / 5 fractions per week, over 7 weeks

Study groups in NCT02236936
Study groupRoleWhat they receive
Arm A - Standard of careActive comparatorStandard care of parenteral nutrition (with or without parenteral nutrition during radio-chemotherapy or radio-immunotherapy in combination with Cetuximab or Cisplatin. Concomitant radiotherapy and immunotherapy (radio-immunotherapy) with Cetuximab or concomitant radiotherapy and chemotherapy (radio-chemotherapy) with Cisplatin
Receives: Dietary Supplement: Standard care of parenteral nutrition; Biological: Cetuximab; Drug: Cisplatin; Radiation: Radiotherapy
Arm B - Parenteral over night nutritionExperimentalParenteral over night nutrition with ZentroOLIMEL 5.7% parenteral over night with electrolytes, vitamins (Cernevit®) and micronutrients (Addel Trace® or Nutryelt®) 15 ml/kg body weight/day (weight loss >5% from baseline; parenteral nutrition increased up to 25 ml/kg body weight per day) during radio-chemotherapy or radio-immunotherapy in combination with Cetuximab or Cisplatin. Concomitant radiotherapy and immunotherapy (radio-immunotherapy) with Cetuximab or concomitant radiotherapy and chemotherapy (radio-chemotherapy) with Cisplatin
Receives: Dietary Supplement: Parenteral over night nutrition; Biological: Cetuximab; Drug: Cisplatin; Radiation: Radiotherapy

What is being measured

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

  1. Loss of body weight by more than 5% at the end of radiotherapy

    Weekly body weight assessments - standardized method for all study sites

    Measured: Difference between baseline and week 8 (after end of RTX)

Secondary outcomes (1)

  1. Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation

    Determination of parameters on functional nutritional status: fat-free mass (FFM), total body water (TBW), body fat and phase angle will be evaluated by BIA

    Measured: Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX

Timeline

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

  1. First posted11 Sep 2014 (estimated)
  2. Study start3 Feb 2017
  3. Primary completion10 Jul 2019
  4. Study completion10 Jul 2019

Why it stopped: Study stopped due to low 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02236936
Sponsor's protocol ID
AGMT_HNO_PN
Acronym
AGMT_HNO_PN
Status last verified
Apr 2020
First submitted
5 Sep 2014
Last updated
1 May 2020
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 3 study testing Parenteral over night nutrition, Cetuximab and Cisplatin in people with Squamous Cell Carcinoma of the Hypopharynx Stage III and Squamous Cell Carcinoma of the Hypopharynx Stage IV, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.

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 6 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: stopped early, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Austria. 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 was stopped early (reason given: Study stopped due to low 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?

Loss of body weight by more than 5% at the end of radiotherapy (time frame: Difference between baseline and week 8 (after end of RTX)). 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 NCT02236936.

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 2020.

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