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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
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 29, 2018
    Last Updated
    May 12, 2018
    Sponsor
    Ludwig-Maximilians - University of Munich
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    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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