Clinical trial NCT02236936: Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of the Hypopharynx Stage III
Squamous Cell Carcinoma of the Hypopharynx Stage IV
Laryngeal Squamous Cell Carcinoma Stage III
Laryngeal Squamous Cell Carcinoma Stage IV
Oropharyngeal Squamous Cell Carcinoma Stage III
Oropharyngeal Squamous Cell Carcinoma Stage IV
Squamous Cell Carcinoma of the Oral Cavity Stage III
Squamous Cell Carcinoma of the Oral Cavity Stage IV
Locally Advanced Malignant Neoplasm
Keywords: Squamous Cell Carcinoma
Head and neck
SCCHN
Parenteral nutrition
Larynx
Hypopharynx
Cavum oris
Radiotherapy
Cetuximab
Cisplatin
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2014-09-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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).

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Loss of body weight by more than 5% at the end of radiotherapy
timeFrame: Difference between baseline and week 8 (after end of RTX)
Secondary outcomes:
measure: Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation
timeFrame: Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX
Other outcomes:
measure: Assessment of physical strength
timeFrame: Prior to RTX, weekly during RTX, within 1 week and 3 months after end of RTX
measure: Number of implanted PEG tubes
timeFrame: From start of RTX until 3 months after end of RTX
measure: Acute toxicity during radiotherapy
timeFrame: During 7 weeks of radiotherapy, at end of radiotherapy and 3 months after radiotherapy
measure: Chronic toxicity after treatment
timeFrame: 3 months after end of radiotherapy
measure: Dose and dose intensity of radiotherapy
timeFrame: At start and end of radiotherapy (duration of radiotherapy 7 weeks)
measure: Progression-free (PFS)
timeFrame: From start until 3 months after end of RTX
measure: Overall survival (OS)
timeFrame: From start until 3 months after end of RTX
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Graz
country: Austria
facility: Medizinische Universität Graz, HNO Universitätsklinik
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee, HNO-Abteilung
city: Linz
country: Austria
facility: Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie
city: Vienna
country: Austria
facility: Hanuschkrankenhaus
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Wien
country: Austria
facility: Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie
Study officials:
affiliation: Hanuschkrankenhaus
name: Felix Keil, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: