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

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

NCT02236936•Arbeitsgemeinschaft medikamentoese Tumortherapie

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (7)

Landeskrankenhaus Feldkirch

Feldkirch, Austria

Medizinische Universität Graz, HNO Universitätsklinik

Graz, Austria

Klinikum Klagenfurt am Wörthersee, HNO-Abteilung

Klagenfurt, Austria

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

Linz, Austria

Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie

Vienna, Austria

Hanuschkrankenhaus

Vienna, Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, Austria

Key Dates

Start Date

February 3, 2017

Primary Completion Date

July 10, 2019

Completion Date

July 10, 2019

Last Updated

May 1, 2020

Enrollment

ACTUAL participants

Conditions

Squamous Cell Carcinoma of the Hypopharynx Stage IIISquamous Cell Carcinoma of the Hypopharynx Stage IVLaryngeal Squamous Cell Carcinoma Stage IIILaryngeal Squamous Cell Carcinoma Stage IVOropharyngeal Squamous Cell Carcinoma Stage IIIOropharyngeal Squamous Cell Carcinoma Stage IVSquamous Cell Carcinoma of the Oral Cavity Stage IIISquamous Cell Carcinoma of the Oral Cavity Stage IVLocally Advanced Malignant Neoplasm

Interventions

Standard care of parenteral nutrition

DIETARY_SUPPLEMENT

Parenteral over night nutrition

DIETARY_SUPPLEMENT

Cetuximab

BIOLOGICAL

Cisplatin

DRUG

Radiotherapy

RADIATION