Clinical trial · Interventional
Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study stopped due to low recruitment
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngeal Squamous Cell Carcinoma Stage III | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Laryngeal Squamous Cell Carcinoma Stage IV | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Oropharyngeal Squamous Cell Carcinoma Stage III | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Oropharyngeal Squamous Cell Carcinoma Stage IV | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma of the Hypopharynx Stage III | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A - Standard of care
- 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
- interventionNames
- Dietary Supplement: Standard care of parenteral nutrition
- Biological: Cetuximab
- Drug: Cisplatin
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Arm B - Parenteral over night nutrition
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available