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

NCT ID: NCT01509430

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Early training patient

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

Group Type EXPERIMENTAL

Progressive Resistance Exercise Training

Intervention Type OTHER

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

Late training patients

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

Group Type EXPERIMENTAL

Progressive Resistance Exercise Training

Intervention Type OTHER

12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training

Interventions

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Progressive Resistance Exercise Training

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

Intervention Type OTHER

Progressive Resistance Exercise Training

12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Head and Neck Cancer Group

NETWORK

Sponsor Role lead

Responsible Party

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Jens Overgaard

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Overgaard, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Danish Head and Neck Cancer Group

Locations

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Dept. of Experimental Clinical Oncology

Aarhus C, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://www.dahanca.dk/

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

Other Identifiers

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DAHANCA 25B

Identifier Type: -

Identifier Source: org_study_id