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

Locally Advanced Malignant Neoplasm Clinical Trial

— AGMT_HNO_PN  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02236936
• Other study ID #: AGMT_HNO_PN
• Status: Terminated
• Phase: Phase 3
• Start date: February 3, 2017
• Est. completion date: July 10, 2019

Study information

• Verified date: April 2020
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Laryngeal Squamous Cell Carcinoma Stage III
• Laryngeal Squamous Cell Carcinoma Stage IV
• Locally Advanced Malignant Neoplasm
• Neoplasms
• Oropharyngeal Squamous Cell Carcinoma Stage III
• Oropharyngeal Squamous Cell Carcinoma Stage IV
• Squamous Cell Carcinoma of the Hypopharynx Stage III
• Squamous Cell Carcinoma of the Hypopharynx Stage IV
• Squamous Cell Carcinoma of the Oral Cavity Stage III
• Squamous Cell Carcinoma of the Oral Cavity Stage IV

Intervention

Dietary Supplement:
• Standard care of parenteral nutrition
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 nutrition
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.

Biological:
• Cetuximab
Weekly during radiotherapy; not given if cisplatin is given during radiotherapy Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)

Drug:
• Cisplatin
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

Radiation:
• Radiotherapy
70 Gy / 5 fractions per week, over 7 weeks

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch	Feldkirch
Austria	Medizinische Universität Graz, HNO Universitätsklinik	Graz
Austria	Klinikum Klagenfurt am Wörthersee, HNO-Abteilung	Klagenfurt am Wörthersee
Austria	Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie	Linz
Austria	Hanuschkrankenhaus	Vienna
Austria	Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie	Wien
Austria	Landesklinikum Wiener Neustadt	Wiener Neustadt

Sponsors (2)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of physical strength	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
Other	Number of implanted PEG tubes	The number of implanted PEG tubes will be recorded	From start of RTX until 3 months after end of RTX
Other	Acute toxicity during 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
Other	Chronic toxicity after treatment	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
Other	Dose and dose intensity of radiotherapy	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)
Other	Progression-free (PFS)	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
Other	Overall survival (OS)	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
Primary	Loss of body weight by more than 5% at the end of radiotherapy	Weekly body weight assessments - standardized method for all study sites	Difference between baseline and week 8 (after end of RTX)
Secondary	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	Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX

External Links

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