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Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jens Overgaard, Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier:
NCT01509430
First received: January 3, 2012
Last updated: April 15, 2013
Last verified: April 2013

January 3, 2012
April 15, 2013
October 2011
April 2013   (final data collection date for primary outcome measure)
Body composition [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
Lean body mass and fat mass assessed by DEXA scanning
Same as current
Complete list of historical versions of study NCT01509430 on ClinicalTrials.gov Archive Site
  • Maximal muscle strength [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Isometric and isokinetic muscle dynamometry
  • Maximal gait speed [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    10 m walk time
  • Patient reported outcomes [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Questionaires on Quality of Life, Fatigue and Mood
  • Blood sampling [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Investigation of changes in serum level of markers related to weigth loss, inflammation and muscle hypertrophy
  • 30 s arm curl capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Stair climbing capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Jumping capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Counter Movement Jumps
  • Chair rise capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    30 s chair rise
  • Maximal muscle strength [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Isometric and isokinetic muscle dynamometry
  • Maximal gait speed [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    10 m walk time
  • Patient reported outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Questionaires on Quality of Life, Fatigue and Mood
  • Blood sampling [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Investigation of changes in serum level of markers related to weigth loss, inflammation and muscle hypertrophy
  • 30 s arm curl capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Stair climbing capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Jumping capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Counter Movement Jumps
  • Chair rise capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    30 s chair rise
Not Provided
Not Provided
 
Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial

Head and neck cancer patients often experience a critical weight loss of around 10% following radiation therapy. Of this up to 70% is muscle mass and is an independent predictor of mortality, lowers muscle strength and functional performance. The purpose of this study is in a randomized controlled trial to investigate the effects of progressive resistance training (PRET) on changes in muscle mass, muscle strength and functional performance in head and neck cancer survivors. The investigators hypothesize that PRET has a positive effect on all primary endpoints and increases muscle mass, muscle strength and functional performance.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Head and Neck Cancer
  • Other: Progressive Resistance Exercise Training
    12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training
  • Other: Progressive Resistance Exercise Training
    12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training
  • Experimental: Early training patient
    12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity
    Intervention: Other: Progressive Resistance Exercise Training
  • Experimental: Late training patients
    12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training
    Intervention: Other: Progressive Resistance Exercise Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically diagnosed with squamous cell carcinomas of the larynx (no glottis stage I+II), pharynx, oral cavity or in lymph nodes from an unknown primary tumour (stage I-IV and tumour node metastasis (TNM) classification, UICC, Geneva, 1987)
  • Terminated curative radiotherapy treatment with/without chemotherapy;
  • No metastases
  • Complete tumour remission
  • No current or previous malignancies that could prevent participation and training
  • No excessive alcohol intake (men > 21 and women > 14 units/wk)
  • No recent systematic resistance training or creatine ingestion (within 2 months)
  • If woman, not pregnant
  • WHO performance status of 0-1
  • No psychological, social or geographical conditions that could disturb participation
  • Written consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01509430
DAHANCA 25B
Yes
Jens Overgaard, Danish Head and Neck Cancer Group
Danish Head and Neck Cancer Group
Not Provided
Principal Investigator: Jens Overgaard, Prof., MD Danish Head and Neck Cancer Group
Danish Head and Neck Cancer Group
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP