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

NCT01509430 | Completed DMC

• 1 other identifier: DAHANCA 25B
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Body composition

  Lean body mass and fat mass assessed by DEXA scanning

  Baseline, 3 months and 6 months

Secondary Outcomes (8)

• Maximal muscle strength

  Baseline, 3 months and 6 months

• Maximal gait speed

  Baseline, 3 months and 6 months

• Patient reported outcomes

  Baseline, 3 months and 6 months

• Blood sampling

  Baseline, 3 months and 6 months

• 30 s arm curl capacity

  Baseline, 3 months, 6 months

Study Arms (2)

Early training patient

EXPERIMENTAL

12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity

Other: Progressive Resistance Exercise Training

Late training patients

EXPERIMENTAL

12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training

Other: Progressive Resistance Exercise Training

Interventions

Progressive Resistance Exercise Training OTHER

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

Early training patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Danish Head and Neck Cancer Group: lead

Study Sites (1)

Dept. of Experimental Clinical Oncology

Aarhus C, 8000, Denmark

Location

Related Links

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

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jens Overgaard, Prof., MD

  Danish Head and Neck Cancer Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 13, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 29, 2016

Record last verified: 2016-11

Locations

DK (1)