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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Progressive Resistance Exercise Training; Other: Progressive Resistance Exercise Training

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Dept. of Experimental Clinical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Other: Progressive Resistance Exercise Training; 12 weeks of self chosen training followed by 12 weeks of 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Lean body mass and fat mass assessed by DEXA scanning	Baseline, 3 months and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Danish Head and Neck Cancer Group
• Investigators: Principal Investigator: Jens Overgaard, Prof., MD, Danish Head and Neck Cancer Group

Publications and helpful links

Helpful Links

• The website for the Danish Head and Neck Cancer Group (DAHANCA).

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: January 12, 2012
• First Posted (ESTIMATE): January 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 29, 2016
• Last Update Submitted That Met QC Criteria: November 28, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: DAHANCA 25B