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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509430
• Other study ID #: DAHANCA 25B
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: November 28, 2016
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2016
• Source: Danish Head and Neck Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Progressive Resistance Exercise Training
12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training
• Progressive Resistance Exercise Training
12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training

Locations

Country	Name	City	State
Denmark	Dept. of Experimental Clinical Oncology	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
Danish Head and Neck Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Lean body mass and fat mass assessed by DEXA scanning	Baseline, 3 months and 6 months	No
Secondary	Maximal muscle strength	Isometric and isokinetic muscle dynamometry	Baseline, 3 months and 6 months	No
Secondary	Maximal gait speed	10 m walk time	Baseline, 3 months and 6 months	No
Secondary	Patient reported outcomes	Questionaires on Quality of Life, Fatigue and Mood	Baseline, 3 months and 6 months	No
Secondary	Blood sampling	Investigation of changes in serum level of markers related to weight loss, inflammation and muscle hypertrophy	Baseline, 3 months and 6 months	No
Secondary	30 s arm curl capacity		Baseline, 3 months, 6 months	No
Secondary	Stair climbing capacity		Baseline, 3 months, 6 months	No
Secondary	Jumping capacity	Counter Movement Jumps	Baseline, 3 months, 6 months	No
Secondary	Chair rise capacity	30 s chair rise	Baseline, 3 months, 6 months	No

External Links

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