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DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients

NCT ID: NCT01025518

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-01-31

Brief Summary

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The purpose of this study is to investigate whether resistance training in combination with dietary supplementation is tolerable among head and neck cancer patients and to evaluate the possible effect on muscle mass, strength and functional capacity.

Detailed Description

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Head and neck cancer patients experience a significant loss of muscle mass following radiotherapy treatment due to cachexia and dysphagia. This negatively affects muscle strength and functional capacity.

Studies on healthy individuals and various groups of patients show that resistance training in combination with protein and creatine ingestion is an effective means of increasing muscle mass, strength and functional capacity.

Thus the aim is to investigate the following:

* is resistance training and dietary supplements tolerable among head and neck cancer patients
* the effect of the intervention on muscle mass, strength and functional capacity

Conditions

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Head and Neck Neoplasms

Keywords

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Head and Neck Neoplasms Resistance training Muscle mass Functional capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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resistance training and dietary supplement

Group Type EXPERIMENTAL

Resistance training

Intervention Type OTHER

12 weeks of resistance training in combination with protein and creatine or placebo ingestion

Protein and creatine

Intervention Type DIETARY_SUPPLEMENT

30 g of protein with each training session, 5 g of creatine pr day

Resistance training and placebo ingestion

12 weeks of resistance training and placebo ingestion

Group Type PLACEBO_COMPARATOR

Resistance training

Intervention Type OTHER

12 weeks of resistance training in combination with protein and creatine or placebo ingestion

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrine

Interventions

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Resistance training

12 weeks of resistance training in combination with protein and creatine or placebo ingestion

Intervention Type OTHER

Protein and creatine

30 g of protein with each training session, 5 g of creatine pr day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrine

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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In2Zyme WP80 and In2Zyme Biodrive 1

Eligibility Criteria

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Inclusion Criteria

* head and neck cancer patients (localized to the larynx, pharynx and oral cavity) treated with curative radiotherapy
* complete loss of tumor
* WHO performance status between 0-1 and expected ability to complete the training protocol
* No parenteral feeding
* above the age of 18
* written concent

Exclusion Criteria

* other malignant diseases
* pregnancy
* undergoing systematic resistance training or creatin ingestion
* Alcohol abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Center for Interventional Research in Radiation Oncology (CIRRO)

OTHER

Sponsor Role collaborator

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, Professor, MD

Role: STUDY_CHAIR

DAHANCA

Locations

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Dept. of Experimental Clinical Oncology, Aarhus University Hospital

Aarhus, Region Midt, Denmark

Site Status

Dept. of Experimental Clinical Oncology

Aarhus, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://www.dahanca.dk

Danish Head and Neck Cancer Group

Other Identifiers

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CIRRO-IP010309

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Ethical Comittee: 20090181

Identifier Type: -

Identifier Source: secondary_id

DAHANCA 25A

Identifier Type: -

Identifier Source: org_study_id