NOURISH Study- Nutritional Outcomes and Underlying Risk Investigation in Supportive Head and Neck Cancer Care

NOURISH Study- Nutritional Outcomes and Underlying Risk Investigation in Supportive Head and Neck Cancer Care - NOURISH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039035

Enrollment

120

Registered

2026-02-05

Start date

2026-03-02

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer

Interventions

Group 1: The study focuses on baseline nutritional assessment and longitudinal follow-up across defined treatment stages. A possible follow-up interventional study may be subsequently designed, if w

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria (All Groups) - Histologically confirmed HNC (squamous or related malignancy). - Ongoing or planned treatment matching one of the study groups. - Age = 18 years; ECOG 0–2. - Written informed consent; ability to undergo BIA, blood sampling, and questionnaires.

Exclusion criteria

Exclusion criteria: Exclusion Criteria (All Groups) - Severe uncontrolled infection or comorbidity interfering with participation.

Design outcomes

Primary

Measure	Time frame
The primary outcome ist to investigate whether baseline nutritional and inflammatory status (nutrition-risk screening, mGPS, and micronutrient profile) predicts the trajectory of body composition, micronutrient status, and physical function during treatment and early recovery in patients with head and neck cancer, with measurements of the relevant parameters taken at four predefined time points approximately four months apart (V0: baseline/pre-treatment, V1: 4 months/treatment phase or early follow-up, V2: 8 months/interim follow-up, V3: 12 months/final assessment).	—

Measure

Time frame

The primary outcome ist to investigate whether baseline nutritional and inflammatory status (nutrition-risk screening, mGPS, and micronutrient profile) predicts the trajectory of body composition, micronutrient status, and physical function during treatment and early recovery in patients with head and neck cancer, with measurements of the relevant parameters taken at four predefined time points approximately four months apart (V0: baseline/pre-treatment, V1: 4 months/treatment phase or early follow-up, V2: 8 months/interim follow-up, V3: 12 months/final assessment).

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Secondary

Measure	Time frame
The secondary objectives are to estimate the prevalence of malnutrition and micronutrient deficiencies at diagnosis; to characterize longitudinal changes in body composition, anthropometry, inflammatory markers, and functional measures; to examine associations between systemic inflammation, micronutrient status, and body composition or function at baseline; to evaluate the predictive value of nutrition-risk screening tools (NRS-2002, PG-SGA); to assess the feasibility of longitudinal nutritional and biochemical monitoring in routine care; to inform a potential follow-up intervention testing targeted supplementation (vitamins, trace elements, omega-3) to improve outcomes; and, for patients receiving immune checkpoint inhibitors, to assess how nutritional and metabolic status affects treatment response, tolerability, and outcomes, and to explore predictive nutritional or metabolic biomarkers associated with response, progression-free survival, and immune-related adverse events.	—

Measure

Time frame

The secondary objectives are to estimate the prevalence of malnutrition and micronutrient deficiencies at diagnosis; to characterize longitudinal changes in body composition, anthropometry, inflammatory markers, and functional measures; to examine associations between systemic inflammation, micronutrient status, and body composition or function at baseline; to evaluate the predictive value of nutrition-risk screening tools (NRS-2002, PG-SGA); to assess the feasibility of longitudinal nutritional and biochemical monitoring in routine care; to inform a potential follow-up intervention testing targeted supplementation (vitamins, trace elements, omega-3) to improve outcomes; and, for patients receiving immune checkpoint inhibitors, to assess how nutritional and metabolic status affects treatment response, tolerability, and outcomes, and to explore predictive nutritional or metabolic biomarkers associated with response, progression-free survival, and immune-related adverse events.

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Countries

Germany

Contacts

Public ContactEmily Newton-Tanzer

Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie; Phoniatrie und Pädaudiologie

emily.newton-tanzer@uksh.de+49 431 500-21701

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026