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

Not Applicable

• Conditions: C00; C01; C02; C03; C04; C05; C06; C07; C08; C09

• Registration Number: DRKS00014956
• Lead Sponsor: niversitätsklinikum Carl Gustav Carus Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 101

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of body weight until the end of radio(chemo)therapy and 3 and 6 months thereafter;<br>Development of physical condition (6-minute walk test, hand strength) until the end of radio(chemo)therapy and 3 and 6 months thereafter <br>

Secondary Outcome Measures

Name	Time	Method
Therapy tolerance (total dose of radiotherapy, therapy interruptions, cycles of chemotherapy),<br>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<br>