Physical Exercise for Patients Who Suffer From Weight Loss Due to Head and Neck Cancer Undergoing Medical Treatment
Primary Purpose
Head and Neck Cancer, Cachexia; Cancer, Resistance Training
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training Group
Control Group
Arm Description
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).
The control group received usual care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03524755
First Posted
April 29, 2018
Last Updated
May 12, 2018
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT03524755
Brief Title
Physical Exercise for Patients Who Suffer From Weight Loss Due to Head and Neck Cancer Undergoing Medical Treatment
Official Title
Effects of a Progressive Resistance Training in Cachectic Cancer Patients During Radiotherapy - a Randomized Controlled Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2013 (Actual)
Primary Completion Date
May 7, 2015 (Actual)
Study Completion Date
May 7, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Cachexia; Cancer, Resistance Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group received usual care.
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Change from Baseline Cancer-related fatigue at post-radiotherapy and follow-up
Description
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.
Time Frame
Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks)
Secondary Outcome Measure Information:
Title
Change from Baseline Anorexia/Cachexia at post-radiotherapy and follow-up
Description
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
Time Frame
Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Belka, Prof. Dr.
Organizational Affiliation
Klinikum der Universität München, Klinik und Poliklinik für Strahlentherapie und Radioonkologie
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
My institution does not require data sharing and because of ethical concerns.
Citations:
PubMed Identifier
17285641
Citation
Couch M, Lai V, Cannon T, Guttridge D, Zanation A, George J, Hayes DN, Zeisel S, Shores C. Cancer cachexia syndrome in head and neck cancer patients: part I. Diagnosis, impact on quality of life and survival, and treatment. Head Neck. 2007 Apr;29(4):401-11. doi: 10.1002/hed.20447.
Results Reference
background
PubMed Identifier
20052559
Citation
Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6. Erratum In: J Cancer Surviv. 2011 Mar;5(1):112.
Results Reference
background
PubMed Identifier
8546913
Citation
Smets EM, Garssen B, Cull A, de Haes JC. Application of the multidimensional fatigue inventory (MFI-20) in cancer patients receiving radiotherapy. Br J Cancer. 1996 Jan;73(2):241-5. doi: 10.1038/bjc.1996.42.
Results Reference
background
PubMed Identifier
11401046
Citation
Ribaudo JM, Cella D, Hahn EA, Lloyd SR, Tchekmedyian NS, Von Roenn J, Leslie WT. Re-validation and shortening of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Qual Life Res. 2000;9(10):1137-46. doi: 10.1023/a:1016670403148.
Results Reference
background
PubMed Identifier
23444095
Citation
Schmidt K, Vogt L, Thiel C, Jager E, Banzer W. Validity of the six-minute walk test in cancer patients. Int J Sports Med. 2013 Jul;34(7):631-6. doi: 10.1055/s-0032-1323746. Epub 2013 Feb 26.
Results Reference
background
PubMed Identifier
30400971
Citation
Grote M, Maihofer C, Weigl M, Davies-Knorr P, Belka C. Progressive resistance training in cachectic head and neck cancer patients undergoing radiotherapy: a randomized controlled pilot feasibility trial. Radiat Oncol. 2018 Nov 6;13(1):215. doi: 10.1186/s13014-018-1157-0.
Results Reference
derived
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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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