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

NCT02236936 | Terminated Phase 3

• 1 other identifier: AGMT_HNO_PN
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 7

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

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

Other Outcomes (7)

• Assessment of physical strength

  Prior to RTX, weekly during RTX, within 1 week and 3 months after end of RTX

• Number of implanted PEG tubes

  From start of RTX until 3 months after end of RTX

• Acute toxicity during radiotherapy

  During 7 weeks of radiotherapy, at end of radiotherapy and 3 months after radiotherapy

Study Arms (2)

Arm A - Standard of care

ACTIVE COMPARATOR

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

Dietary Supplement: Standard care of parenteral nutrition; Biological: Cetuximab; Drug: Cisplatin; Radiation: Radiotherapy

Arm B - Parenteral over night nutrition

EXPERIMENTAL

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

Dietary Supplement: Parenteral over night nutrition; Biological: Cetuximab; Drug: Cisplatin; Radiation: Radiotherapy

Interventions

Standard care of parenteral nutrition DIETARY_SUPPLEMENT

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

Also known as: PN

Arm A - Standard of care

Parenteral over night nutrition DIETARY_SUPPLEMENT

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.

Also known as: Emulsion for infusion

Arm B - Parenteral over night nutrition

Cetuximab BIOLOGICAL

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

Also known as: Erbitux

Arm A - Standard of care; Arm B - Parenteral over night nutrition

Cisplatin DRUG

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

Also known as: Cisplatinum, CDDP

Arm A - Standard of care; Arm B - Parenteral over night nutrition

Radiotherapy RADIATION

70 Gy / 5 fractions per week, over 7 weeks

Also known as: RTX

Arm A - Standard of care; Arm B - Parenteral over night nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead
• Medical University of Graz: collaborator

Study Sites (7)

Landeskrankenhaus Feldkirch

Feldkirch, A-6807, Austria

Location

Medizinische Universität Graz, HNO Universitätsklinik

Graz, A-8036, Austria

Location

Klinikum Klagenfurt am Wörthersee, HNO-Abteilung

Klagenfurt, A-9020, Austria

Location

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

Linz, 4010, Austria

Location

Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie

Vienna, 1130, Austria

Location

Hanuschkrankenhaus

Vienna, 1140, Austria

Location

Landesklinikum Wiener Neustadt

Wiener Neustadt, 2700, Austria

Location

Related Links

• Sponsor

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell; Hyperphagia; Laryngeal Diseases

Interventions

Emulsions; Cetuximab; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• Felix Keil, Prof.Dr.

  Hanuschkrankenhaus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 11, 2014
• Study Start: February 3, 2017
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

AU (7)