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

Not Applicable

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT01509430
• Lead Sponsor: Danish Head and Neck Cancer Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-13
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body composition	Baseline, 3 months and 6 months	Lean body mass and fat mass assessed by DEXA scanning

Secondary Outcome Measures

Name	Time	Method
Maximal muscle strength	Baseline, 3 months and 6 months	Isometric and isokinetic muscle dynamometry
Maximal gait speed	Baseline, 3 months and 6 months	10 m walk time
Patient reported outcomes	Baseline, 3 months and 6 months	Questionaires on Quality of Life, Fatigue and Mood
Blood sampling	Baseline, 3 months and 6 months	Investigation of changes in serum level of markers related to weight loss, inflammation and muscle hypertrophy
30 s arm curl capacity	Baseline, 3 months, 6 months
Stair climbing capacity	Baseline, 3 months, 6 months
Jumping capacity	Baseline, 3 months, 6 months	Counter Movement Jumps
Chair rise capacity	Baseline, 3 months, 6 months	30 s chair rise

Trial Locations

Locations (1)

Dept. of Experimental Clinical Oncology; 🇩🇰 Aarhus C, Denmark