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

A Randomized Trial Evaluating Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01025518

Enrollment

Registered

2009-12-03

Start date

2009-09-30

Completion date

2012-01-31

Last updated

2016-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

Keywords

Head and Neck Neoplasms, Resistance training, Muscle mass, Functional capacity

Brief summary

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

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

Interventions

OTHERResistance training

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

DIETARY_SUPPLEMENTProtein and creatine

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

DIETARY_SUPPLEMENTPlacebo

Maltodextrine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Muscle mass and muscle strength	13 weeks

Secondary

Measure	Time frame
Functional capacity	13 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026