Head and Neck Cancer Clinical Trial
Official title:
Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University
Background: Eating difficulty is one of the most common problems faced by head and neck
cancer (HNC) patients and it might influence patients' general function and psychological
function. Unfortunately, the eating difficulties in HNC patients are not fully understood due
to limited research presented.
Purposes: The study is a 2-year longitudinal following up research. The purpose of the study
aim to (1) examine the characteristics and severity of eating difficulty, (2) identify
factors related to the eating difficulty, and (3) short and long-term impact and correlation
of eating difficulty on HNC patients' general physical condition and depression.
Method: Eligible patient will be HNC patients receiving surgery and CCRT. Patients will be
recruited and assessed in 6 time points: before first CCRT (T1) and 4weeks, 8 week, 12 week ,
6 month, and 12 month from CCRT (T2~T6). Patients will be assessed nutrition status, body
weight, fatigue severity, and grip power of the dominant hand, and depression. IRB and
patient consents will be obtained before data collection. The descriptive and correlational
analyses will be applied to analyze the data. The investigators plan to recruit 125 subjects.
The longitudinal data will be analyzed by GEE to examine the changes of main variables and
predictors of eating difficulty.
Expected Outcome: The results of this study will provide evidence about HNC patients' eating
difficulty. It will increase health care professionals' understanding about HNC patients'
problems in eating difficulties, related factors and their relationship with general
function. The investigators hope to further develop an intervention based on the results to
enhance HNC patients' eating function.
This is a longitudinal study which aims to examine the short- and long-term eating
difficulties, its related factors and its impacts. The participants will be recruited in the
outpatient department of Ear, Nose, and Throat (ENT) in NTUH. The inclusion criteria are (a)
diagnosed as head and neck cancer; (b) will be received cancer treatments including surgery
and CCRT; (c) age is 20 or older. The exclusion criteria are (a) the patient is inserted a
plastic tube, e.g. nasogastric tube (NG) or percutaneous endoscopic gastrostomy tube (PEG),
for feeding; (b) patients could not understand the content of questionnaires. The
investigators will recruit 100 subjects with complete 12-month data. Concerning 25% patients
loss rate, the investigators will recruit 125 subjects at the beginning of the first year.
Patients will be assessed by Chewing Swallowing Inventory (CSI), Mini Nutritional Assessment
(MNA), Depression subscale of Hospital Anxiety and Depression Scale (HADS), Symptom Severity
Scale (SSS), 0-10 general Fatigue severity numerical scale, and disease and treatment
background Information Form (BIF). Grip power of dominant hand will be assessed by hand
dynamometer.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
| Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
| Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
| Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
| Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
| Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
| Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
| Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
| Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
| Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |