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

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).

Study Overview

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 .

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Feldkirch, Austria, A-6807
        • Landeskrankenhaus Feldkirch
      • Graz, Austria, A-8036
        • Medizinische Universität Graz, HNO Universitätsklinik
      • Klagenfurt am Wörthersee, Austria, A-9020
        • Klinikum Klagenfurt am Wörthersee, HNO-Abteilung
      • Linz, Austria, 4010
        • Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie
      • Vienna, Austria, 1140
        • Hanuschkrankenhaus
      • Wien, Austria, 1130
        • Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie
      • Wiener Neustadt, Austria, 2700
        • Landesklinikum Wiener Neustadt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A - Standard of care

Standard 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

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
Other Names:
  • PN

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

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

Other Names:
  • Erbitux
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
Other Names:
  • CDDP
  • Cisplatinum
70 Gy / 5 fractions per week, over 7 weeks
Other Names:
  • RTX
Experimental: Arm B - Parenteral over night nutrition

Parenteral 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

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

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

Other Names:
  • Erbitux
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
Other Names:
  • CDDP
  • Cisplatinum
70 Gy / 5 fractions per week, over 7 weeks
Other Names:
  • RTX
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.
Other Names:
  • Emulsion for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Weekly body weight assessments - standardized method for all study sites
Difference between baseline and week 8 (after end of RTX)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation
Time Frame: Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX
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
Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of physical strength
Time Frame: Prior to RTX, weekly during RTX, within 1 week and 3 months after end of RTX
Handgrip strength measurement, mean value of three consecutive measurements
Prior to RTX, weekly during RTX, within 1 week and 3 months after end of RTX
Number of implanted PEG tubes
Time Frame: From start of RTX until 3 months after end of RTX
The number of implanted PEG tubes will be recorded
From start of RTX until 3 months after end of RTX
Acute toxicity during radiotherapy
Time Frame: During 7 weeks of radiotherapy, at end of radiotherapy and 3 months after radiotherapy
Acute toxicity according to Common Terminology Criteria for Adverse Events (CTCAE 4.0.)
During 7 weeks of radiotherapy, at end of radiotherapy and 3 months after radiotherapy
Chronic toxicity after treatment
Time Frame: 3 months after end of radiotherapy
Chronic toxicity evaluated according to RTOG (Radiation Therapy Oncology Group)/EORTC (European Organisation for Research and Treatment of Cancer) - Toxicity Criteria
3 months after end of radiotherapy
Dose and dose intensity of radiotherapy
Time Frame: At start and end of radiotherapy (duration of radiotherapy 7 weeks)
Dose and dose intensity including delay of scheduled therapy and absolute dose of radiotherapy applied.
At start and end of radiotherapy (duration of radiotherapy 7 weeks)
Progression-free (PFS)
Time Frame: From start until 3 months after end of RTX
The study will be finished one year post RTX and clinical al data on PFS will be obtained. In addition, patient will be asked to agree to collection of information regarding PFS even after completion of the trial.
From start until 3 months after end of RTX
Overall survival (OS)
Time Frame: From start until 3 months after end of RTX
The study will be finished one year post RTX and clinical data on OS will be obtained. In addition, patient will be asked to agree to collection of information regarding OS even after completion of the trial.
From start until 3 months after end of RTX

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2017

Primary Completion (Actual)

July 10, 2019

Study Completion (Actual)

July 10, 2019

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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