Study of Early Nutritional Supplementation and Exercise in Head and Neck Squamous Cell Carcinoma patients
Organizational Data
- DRKS-ID:
- DRKS00032370
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2024-01-26
- Last update in DRKS:
- 2024-04-25
- Registration type:
- Prospective
Acronym/abbreviation of the study
SENSE-HNSCC
URL of the study
No Entry
Brief summary in lay language
This study aims to examine wether giving additional food and performing a structured home workout can positively improve the course of treatment for head and neck cancer. Patients are randomly assigned to either a pure observational group or an interventional group. The inclusion into the study is at initial presentation with a relevant suspected tumor and additional exams are performed when therapy begins and three months after concluding therapy. The actual intervention is performed until two weeks past beginning treatment which usually means 5-9 weeks.
Brief summary in scientific language
We evaluate the usefulness of multimodal prehabliotation in the treatment of head and neck cancer patients. Inclusion is on first presentation with highly probable head and neck cancer. After Assessment Patients are randomised into an intervention group and a control group. The intervention group is given high calorie drinks and receives a short home exercise program. The intervention should be performed until two weeks past treatment beginning. This should be about 5-9 Weeks overall depending on treatment modality. Followups are performed when treatment begins and three months after concluding cancer treatment.
Health condition or problem studied
- ICD10:
- C02.0 - Dorsal surface of tongue
- ICD10:
- C02.1 - Border of tongue
- ICD10:
- C02.2 - Ventral surface of tongue
- ICD10:
- C02.3 - Anterior two-thirds of tongue, part unspecified
- ICD10:
- C02.4 - Lingual tonsil
- ICD10:
- C02.8 - Overlapping lesion of tongue
- ICD10:
- C09.0 - Tonsillar fossa
- ICD10:
- C09.1 - Tonsillar pillar (anterior)(posterior)
- ICD10:
- C09.8 - Overlapping lesion of tonsil
- ICD10:
- C32.0 - Glottis
- ICD10:
- C32.1 - Supraglottis
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Intervention arm: Dietary supplements in the form of high calorie drinks independent of nutritional status and a home exercise program: - Shrugs with water bottles daily - squats into a chair daily - Use of breathing trainer daily - moderate exercise (biking, walking) for at least 30 minutes 4x a week
- Arm 2:
- Control arm: Nutritional Supplementation in the form of high calorie drinks when there is malnutrition by GLIM criteria. The manual on the exercises used in the study is given to the patients without requesting their implementation: - Shrugs with water bottles daily - squats into a chair daily - Use of breathing trainer daily - moderate exercise (biking, walking) for at least 30 minutes 4x a week
Endpoints
- Primary outcome:
- - Change in body composition at the followup three months after conclusion therapy - Change in bodily fitness at the followup three months after conclusion therapy
- Secondary outcome:
- - Prevalence of delayed discharge and radiation delays - Quality of life differences - Changes in laboratory parameters - Changes in transcriptome and metabolome - Differences in immune modulation - Changes in movement data
Study Design
- Purpose:
- Supportive care
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Patients are randomized after consent
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- Randomization Module in REDCap
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Greifswald Greifswald
Recruitment period and number of participants
- Planned study start date:
- 2024-06-01
- Actual study start date:
- No Entry
- Planned study completion date:
- 2026-03-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 70
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Able to perform exercises - Able to comply with study documentation
Exclusion Criteria
- Patients at risk of injury when complying with the exercise regime - Patients with poorly managed diabetes - Patients unable to give written consent
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin GreifswaldFerdinand-Sauerbruch Str17475 GreifswaldGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medizin.uni-greifswald.de/de/home/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin GreifswaldDr. med. Markus BlaurockFerdinand-Sauerbruch-Str.17475 GreifswaldGermany
- Telephone:
- 03834866236
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsmedizin GreifswaldDr. med. Markus BlaurockFerdinand-Sauerbruch-Str.17475 GreifswaldGermany
- Telephone:
- 03834866236
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsmedizin GreifswaldDr. med. Markus BlaurockFerdinand-Sauerbruch-Str.17475 GreifswaldGermany
- Telephone:
- 03834866236
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsmedizin Greifswald17475 GreifswaldGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der Universitätsmedizin Greifswald, Institut für PharmakologieFelix-Hausdorff-Straße 317487 GreifswaldGermany
- Telephone:
- +49-3834-865644
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www2.medizin.uni-greifswald.de/ethik/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-11-19
- Ethics committee number:
- BB 184/23
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-12-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry