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

D

Danish Head and Neck Cancer Group

Status

Completed

Conditions

Head and Neck Cancer

Treatments

Other: Progressive Resistance Exercise Training

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01509430
DAHANCA 25B

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

41 participants in 2 patient groups

Early training patient
Experimental group
Description:
12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity
Treatment:
Other: Progressive Resistance Exercise Training
Other: Progressive Resistance Exercise Training
Late training patients
Experimental group
Description:
12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training
Treatment:
Other: Progressive Resistance Exercise Training
Other: Progressive Resistance Exercise Training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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