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

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ClinicalTrials.gov Identifier: NCT03524755
Recruitment Status : Completed
First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. med. Dipl.-Phys. Maximilian Niyazi, Ludwig-Maximilians - University of Munich

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Cachexia; Cancer Resistance Training Other: Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Progressive Resistance Training in Cachectic Cancer Patients During Radiotherapy - a Randomized Controlled Pilot Trial
Actual Study Start Date : July 10, 2013
Actual Primary Completion Date : May 7, 2015
Actual Study Completion Date : May 7, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Training Group
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
No Intervention: Control Group
The control group received usual care.



Primary Outcome Measures :
  1. Change from Baseline Cancer-related fatigue at post-radiotherapy and follow-up [ Time Frame: Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks) ]
    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.


Secondary Outcome Measures :
  1. Change from Baseline Anorexia/Cachexia at post-radiotherapy and follow-up [ Time Frame: Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks) ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524755


Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Claus Belka, Prof. Dr. Klinikum der Universität München, Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med. Dipl.-Phys. Maximilian Niyazi, PD Dr. med. Dipl. Phys. Karim- Maximilian Niyazi, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT03524755     History of Changes
Other Study ID Numbers: Cancer Cachexia Exercise
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: My institution does not require data sharing and because of ethical concerns.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Cachexia
Neoplasms by Site
Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms