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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-03

Study Completion Date

2019-07-10

Brief Summary

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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).

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Detailed Description

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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 .

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Standard care of parenteral nutrition

Intervention Type 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

Cetuximab

Intervention Type 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)

Cisplatin

Intervention Type 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

Radiotherapy

Intervention Type RADIATION

70 Gy / 5 fractions per week, over 7 weeks

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

Group Type EXPERIMENTAL

Parenteral over night nutrition

Intervention Type 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.

Cetuximab

Intervention Type 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)

Cisplatin

Intervention Type 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

Radiotherapy

Intervention Type RADIATION

70 Gy / 5 fractions per week, over 7 weeks

Interventions

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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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type BIOLOGICAL

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

Intervention Type DRUG

Radiotherapy

70 Gy / 5 fractions per week, over 7 weeks

Intervention Type RADIATION

Other Intervention Names

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PN Emulsion for infusion Erbitux Cisplatinum CDDP RTX

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No