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Completed

NCT Number: NCT01509430

DAHANCA 25B: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Experimental Clinical Oncology

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive resistance exercise training

Other

12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training

Primary outcomes

  1. Body composition

    Time frame: Baseline, 3 months and 6 months

    Lean body mass and fat mass assessed by DEXA scanning

Secondary outcomes

  1. Maximal muscle strength

    Time frame: Baseline, 3 months and 6 months

    Isometric and isokinetic muscle dynamometry

  2. Maximal gait speed

    Time frame: Baseline, 3 months and 6 months

    10 m walk time

  3. Patient reported outcomes

    Time frame: Baseline, 3 months and 6 months

    Questionaires on Quality of Life, Fatigue and Mood

  4. Blood sampling

    Time frame: Baseline, 3 months and 6 months

    Investigation of changes in serum level of markers related to weight loss, inflammation and muscle hypertrophy

  5. 30 s arm curl capacity

    Time frame: Baseline, 3 months, 6 months

  6. Stair climbing capacity

    Time frame: Baseline, 3 months, 6 months

  7. Jumping capacity

    Time frame: Baseline, 3 months, 6 months

    Counter Movement Jumps

  8. Chair rise capacity

    Time frame: Baseline, 3 months, 6 months

    30 s chair rise

Sponsors and collaborators

Lead sponsor

Danish Head and Neck Cancer Group

Network

Registry information

Official study title

Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 13, 2012
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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