Physical Exercise for Patients Who Suffer From Weight Loss Due to Head and Neck Cancer Undergoing Medical Treatment

Study Overview
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Brief Summary
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Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purpose of this study was to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy in a pilot randomized controlled design. Baseline data for all participants were ascertained via medical records and patient interview. This included demographic information, Union internationale contre le cancer-status (UICC-status), comorbidities and the results of blood samples. Outcomes were measured at admission. One study coordinator completed all assessments to enhance patient compliance. Body weight loss percentage was calculated via the individuals' body weight 6 months before (in retrospect) and the current body weight. Participants completed two questionnaires: The Multidimensional Fatigue Inventory and the Functional Assessment of Anorexia/Cachexia Therapy questionnaire. Six-Minute Walk Test was applied. To document changes in muscle force, strength of the functional muscle group for elbow flexion in supine position as well as of knee extension in sitting position (in each case right and left) was tested via hand-held dynamometry for isometric maximal muscle strength. Bioelectrical impedance analysis was executed to assess the adaption in body composition. The exercise intervention was undertaken in the hospitals department of physical and rehabilitation medicine and based on standardized but individualized training protocols. It consisted of a warm up period for 5 minutes on a bicycle ergometer or an upper body cycle with individual selectable wattage. A leg press, a latissimus pull-down and a chest press formed the three equipment supported core exercises. All exercises were performed with 8-12 repetitions and 3 sets.

Official Title
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Effects of a Progressive Resistance Training in Cachectic Cancer Patients During Radiotherapy - a Randomized Controlled Pilot Trial

Conditions
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Head and Neck Cancer, Cachexia; Cancer, Resistance Training

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: planned inpatient or outpatient radiotherapy ≥ 18 years of age diagnosed state of cachexia (weight loss greater than 5 % over the past 6 months) or pre-cachexia (unintentional weight loss of 5 % or less of usual body weight during the last 6 months) Exclusion Criteria: metastatic disease severe neurological problems or other contraindications for resistance training

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training Group<br>Warm up period for 5 minutes on a bicycle ergometer or an upper body cycle with individual selectable wattage. A leg press, a latissimus pull-down and a chest press formed the three equipment supported core exercises. All exercises were performed with 8-12 repetitions and 3 sets. 3 training sessions (30min for each session) per week for during the course of radiotherapy ( 6 weeks). | Other: Exercise<br> <br> |
| No Intervention: Control Group<br>The control group received usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Cancer-related fatigue at post-radiotherapy and follow-up | The Multidimensional Fatigue Inventory (MFI) which consists of 20 items that measure subgroups (general, physical and mental fatigue as well as reduced motivation and reduced activity) of fatigue with a 5-point Likert scale. | Baseline, post-radiotherapy ( 6weeks), follow-up ( 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Anorexia/Cachexia at post-radiotherapy and follow-up | Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire which registers well-being for physical, social/family, emotional and functional aspects of quality of life and additional concerns in cachexia with 5-point Likert scale for 39 items | Baseline, post-radiotherapy ( 6weeks), follow-up ( 8 weeks) |