Clinical trial · Observational
The Impact of Multimodality Treatment on Physical Functions and Quality of Life in Patients With Head and Neck Cancer
The Impact of Multimodality Treatment on Physical Functions and Quality of Life in Patients With Head and Neck Cancer: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oral cancer (including the lip) alone, with 300.373 cases worldwide in 2012, is the predominant head and neck squamous cell carcinoma. With an incidence of 6.5 cases per 100.000, south - east asia has the highest incidence worldwide. Many of these cases do present at a locally advanced stage, which often requires combined modality treatment that includes extensive surgery to the primary site and neck and flap reconstruction. This is often followed by either adjuvant radiation or chemo-radiotherapy. This treatment can come with a significant morbidity affecting the self-care ability of the patients as well as impact the quality of life(QOL) (3,4).At the SingHealth Duke - NUS Head and Neck Centre 340 complex cases of head and neck cancer (HNC) involving flap reconstructions and extensive resections have been operated in 2014 alone. Almost all of these patients need further adjuvant treatment (radiotherapy and/or chemotherapy). Side-effects following such treatments, Significant number of patients underwent subsequent adjuvant treatment. The adjuvant treatment and surgery may render these patients weakness of the shoulder and neck muscles, numbness and reduced sensation around the neck and shoulder region and a general impact on the patient's fitness. While survival remains the most important outcome in oncologic treatment, recovery of treatment related morbidity and return to pre-treatment QOL for patients after cancer treatment is equally important. The aims of this study is to evaluate the impact of surgical and adjuvant treatment on physical functions and QOL of the patients. By measuring the impact of extensive treatments for head and neck malignancies on the fitness and QOL of these patients, the team aims to identify the risk factors that necessitate a more aggressive rehabilitation. This is to date the first prospective study investigating the impact of multimodality treatment on fitness and QOL in HNC patients in a structured and predefined manner. Ultrasound (US) elastography will be used to assess muscle and soft tissue stiffness and elasticity and correlate these with functional outcome measurements. Elastography has been previously described as a useful tool to assess stiffness of the neck soft tissues and muscles, however no study thus far has correlated these findings with functional measurements. Hence this trial aims to establish the following: 1. Due to the limited available data: to quantify and qualify the impact of surgery as well as adjuvant treatment on the fitness, physical function of the neck and shoulder \& QOL of HNC patients 2. To establish a workflow and assessment protocol for a subsequent larger prospective clinical trial 3. To identify performance markers in these patients, that allow a more targeted rehabilitation process 4. Many patients post head and neck treatment are economically compromised since they are unable to return to mainstream work and there exists a significant unemployment rate. The understanding we gain through objective analysis apart from targeted treatment for every individual patient, in the future this study hopes to address and improve the economic impact to the individual and probably reduce the health care burden.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (18)
- measure
- Change from baseline Shoulder Range of Motion at 6 weeks
- timeFrame
- 1-2 weeks pre surgery, 3-6 weeks post surgery
- description
- Active and passive shoulder movements include abduction, adduction, and flexion, and extension, internal and external rotation.
- measure
- Change from post op 6weeks Shoulder Range of Motion at 6 months
- timeFrame
- 3-6 weeks post surgery, 6 months post surgery
- description
- Active and passive shoulder movements include abduction, adduction, and flexion, and extension, internal and external rotation.
- measure
- Change from baseline Bilateral Strength at 6 weeks
- timeFrame
- 1-2 weeks pre surgery, 3-6 weeks post surgery
- description
- Strength test of the upper and lower limbs will also be performed using an isometric hand-held dynamometer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically proven cancers of the upper aero-digestive tract (oral cavity, oropharynx, nasopharynx or pharynx), skin, thyroid or salivary glands; 2. Case has been indicated for surgical treatment and following adjuvant treatment in the multidisciplinary head and neck tumour board 3. Age: 21 - 70 years 4. ECOG 0 or 1 5. Able to give informed consent Exclusion Criteria: 1. Patients who are not able to undergo primary resection of their HNC(not fit for general anesthesia) 2. Patients with distant metastases or incurable recurrent disease 3. Patients who are currently pregnant or breastfeeding 4. Patients with a history of shoulder surgery or trauma, or any known joint pathology such as rheumatologic disorders, or prior neurological disease affecting the upper and or lower extremity such as stroke; 5. Patients who are receiving a free fibular flap as part of their reconstruction 6. Patients who are on a permanent tracheostomy e.g. after a total laryngectomy 7. Patient with ischaemic heart disease or with current beta blocker medication
References
Publications (0)
Data not yet available