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

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ClinicalTrials.gov Identifier: NCT02236936
Recruitment Status : Recruiting
First Posted : September 11, 2014
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
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 Dietary Supplement: Standard care of parenteral nutrition Dietary Supplement: Parenteral over night nutrition Biological: Cetuximab Drug: Cisplatin Radiation: Radiotherapy Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


Arms and Interventions

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

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
Other Name: PN
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)

Other Name: Erbitux
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
Other Names:
  • Cisplatinum
  • CDDP
Radiation: Radiotherapy
70 Gy / 5 fractions per week, over 7 weeks
Other Name: 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

Dietary Supplement: 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.
Other Name: Emulsion for infusion
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)

Other Name: Erbitux
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
Other Names:
  • Cisplatinum
  • CDDP
Radiation: Radiotherapy
70 Gy / 5 fractions per week, over 7 weeks
Other Name: RTX


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Quality of life (QoL) [ Time Frame: Prior to RTX, 1 week and 3 months after end of RTX and one year after RTX start ]
    Assessment by the Short Form 12 Health Survey Questionnaire

  2. Cachexia associated serum lipid parameters [ Time Frame: Prior to RTX, 1 week and 3 months after end of RTX and one year after RTX start ]
    Triglycerides, cholesterol, VLDL/LDL/HDL profile

  3. Cytokines [ Time Frame: Prior to RTX, 1 week and 3 months after end of RTX and one year after RTX start ]
    Cytokines (optional, only for patients who signed additional informed consent form; TNF-a, IL-6, ZAG = Zinc-α2-glycoprotein)

  4. Adipose triglyceride lipase activity in adipose tissue [ Time Frame: Prior to RTX and 3 months after end of RTX ]
    Incidence of catabolism in cancer patients: Levels of triacylglycerides, glycerol, free fatty acids - obtained optionally by subcutaneous adipose tissue

  5. Assessment of physical strength [ Time Frame: Prior to RTX, weekly during RTX, within 1 week and 3 months after end of RTX and one year after RTX start ]
    Handgrip strength measurement, mean value of three consecutive measurements

  6. Number of implanted PEG tubes [ Time Frame: From start of RTX until 1 year after start of RTX ]
    The number of implanted PEG tubes will be recorded

  7. Changes in ability to swallow [ Time Frame: Prior to RTX, one week after RTX, one year after start of RTX ]
    Ability to swallow will be assessed using the Sydney Swallow Questionnaire (SSQ)

  8. General food intake [ Time Frame: Prior to RTX, during 7 week RTX, one week after RTX ]
    General food intake will be estimated by a weekly adapted nutritionDay questionnaire

  9. 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.)

  10. Chronic toxicity after treatment [ Time Frame: One year after treatment start ]
    Chronic toxicity evaluated according to RTOG (Radiation Therapy Oncology Group)/EORTC (European Organisation for Research and Treatment of Cancer) - Toxicity Criteria

  11. 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.

  12. Progression-free (PFS) [ Time Frame: From start until one year after start 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.

  13. Overall survival (OS) [ Time Frame: From start until one year after start 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236936


Locations
Austria
Landeskrankenhaus Feldkirch Recruiting
Feldkirch, Austria, A-6807
Contact: Alexander De Vries, Univ.Doz. MD    +43 5522303 ext 3300    alexander.devries@lkhf.at   
Principal Investigator: Alexander De Vries, Univ.Doz. MD         
Medizinische Universität Graz, HNO Universitätsklinik Recruiting
Graz, Austria, A-8036
Contact: Dietmar Thurnher, Prof.,MD    +43 316 3851 ext 3448    dietmar.thurnher@medunigraz.at   
Contact: Sabine Reinisch, MD, Senior    +43 316 3851 ext 3448    sabine.reinisch@medunigraz.at   
Principal Investigator: Dietmar Thurnher, Prof.,MD         
Klinikum Klagenfurt am Wörthersee, HNO-Abteilung Not yet recruiting
Klagenfurt am Wörthersee, Austria, A-9020
Contact: Thomas J. Primosch, MD    +43 463 538 ext 27107    thomasprimosch@gmx.at   
Principal Investigator: Thomas J. Primosch, MD         
Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie Not yet recruiting
Linz, Austria, 4010
Contact: Magdalena Sturm, DI    +43 7327677 ext 7521    magdalena.sturm@ordensklinikum.at   
Contact: Martin Burian, Prof.Dr.    +43 7327677 ext 4828    martin.burian@ordenskliniku.at   
Principal Investigator: Martin Burian, Prof.Dr.         
Hanuschkrankenhaus Not yet recruiting
Vienna, Austria, 1140
Contact: Hanna Müller, MSc    +43 1 91021 ext 85435    hanna.mueller@wgkk.at   
Contact: Kathrin Holzer, Mag.    +43 1 91021 ext 85435    kathrin.holzer@wgkk.at   
Principal Investigator: Felix Keil, Prof.Dr.         
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Medical University of Graz
Investigators
Principal Investigator: Felix Keil, Prof.Dr. Hanuschkrankenhaus
More Information

Additional Information:
Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT02236936     History of Changes
Other Study ID Numbers: AGMT_HNO_PN
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
Squamous Cell Carcinoma
Head and neck
SCCHN
Parenteral nutrition
Larynx
Hypopharynx
Cavum oris
Radiotherapy
Cetuximab
Cisplatin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Cetuximab
Antineoplastic Agents