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
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Other: Progressive Resistance Exercise Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Danish Head and Neck Cancer Group:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 41
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early training patient
12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity
Other: Progressive Resistance Exercise Training
12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training
Experimental: Late training patients
12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training
Other: Progressive Resistance Exercise Training
12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509430

Locations
Denmark
Dept. of Experimental Clinical Oncology
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Danish Head and Neck Cancer Group
Investigators
Principal Investigator: Jens Overgaard, Prof., MD Danish Head and Neck Cancer Group
  More Information

Additional Information:
No publications provided

Responsible Party: Jens Overgaard, Professor, MD, Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT01509430     History of Changes
Other Study ID Numbers: DAHANCA 25B
Study First Received: January 3, 2012
Last Updated: April 15, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on July 24, 2014