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Prospective case-control study on supportive treatment in patients with esophageal or head and neck cancer

Prospective case-control study on supportive treatment in patients with esophageal or head and neck cancer - SynErFit

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014956
Enrollment
114
Registered
2018-07-16
Start date
2018-08-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C00 C01 C02 C03 C04 C05 C06 C07 C08 C09 C10 C11 C12 C13 C14 C15 C30 C31 C32

Interventions

Group 1: Interventional Group: Intervention: weekly nutritional advise during radio(chemo)therapy + daily light running with two physiotherapeutic supervisions Group 2: Observational group: standard o

Sponsors

Universitätsklinikum Carl Gustav Carus Dresden
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Gender: Both, male and female, Minimum age: 18 years, Maximum age: 80 years, Squamous cell carcinoma of the head and neck area with indication for primary or adjuvant radio (chemo) therapy, Squamous cell or adenocarcinoma of the esophagus with indication for neoadjuvant or primary radio (chemo) therapy, Histologically proven malignancy, ECOG 0-2, written informed consent

Exclusion criteria

Exclusion criteria: Patient with an indication for palliative radiotherapy, mandatory parenteral nutrition before initiation of radio(chemo)therapy, Pre-existing, irreversible movement restrictions that make the intervention impossible

Design outcomes

Primary

MeasureTime frame
Development of body weight until the end of radio(chemo)therapy and 3 and 6 months thereafter; Development of physical condition (6-minute walk test, hand strength) until the end of radio(chemo)therapy and 3 and 6 months thereafter

Secondary

MeasureTime frame
Therapy tolerance (total dose of radiotherapy, therapy interruptions, cycles of chemotherapy), Side effects (acute and chronic - onset and grading) according to toxicity scoring (CTCAE 4.03), Quality of life (QLQ-C30), Hospitalization time / use of walking aids, Use of additional food / probe nutrition / parenteral nutrition + Duration

Countries

Germany

Contacts

Public ContactAnnett Klöber

Universitätsklinikum und Medizinische Fakultät Carl Gustav Carus der Technischen Universität Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie

str.studien@uniklinikum-dresden.de+49(351) 458-13390

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026