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

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase: Terminated; Phase 3

Conditions: Locally Advanced Malignant Neoplasm; Squamous Cell Carcinoma of the Hypopharynx Stage IV; Laryngeal Squamous Cell Carcinoma Stage III; Squamous Cell Carcinoma of the Hypopharynx Stage III; Squamous Cell Carcinoma of the Oral Cavity Stage IV; Oropharyngeal Squamous Cell Carcinoma Stage III; Squamous Cell Carcinoma of the Oral Cavity Stage III; Oropharyngeal Squamous Cell Carcinoma Stage IV; Laryngeal Squamous Cell Carcinoma Stage IV

Treatments: Dietary Supplement: Standard care of parenteral nutrition; Drug: Cisplatin; Dietary Supplement: Parenteral over night nutrition; Biological: Cetuximab; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02236936

AGMT_HNO_PN

Details and patient eligibility

About

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).

Full 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 .

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Arm A - Standard of care

Active Comparator group

Description:

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

Treatment:

Radiation: Radiotherapy

Biological: Cetuximab

Drug: Cisplatin

Dietary Supplement: Standard care of parenteral nutrition

Arm B - Parenteral over night nutrition

Experimental group

Description:

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

Treatment:

Radiation: Radiotherapy

Biological: Cetuximab

Dietary Supplement: Parenteral over night nutrition

Drug: Cisplatin