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

Danish Head and Neck Cancer Group

Status: Completed

Conditions: Head and Neck Neoplasms

Treatments: Dietary Supplement: Placebo; Other: Resistance training; Dietary Supplement: Protein and creatine

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01025518

DAHANCA 25A

CIRRO-IP010309 (Other Grant/Funding Number)

Ethical Comittee: 20090181

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

resistance training and dietary supplement

Experimental group

Treatment:

Dietary Supplement: Protein and creatine

Other: Resistance training

Resistance training and placebo ingestion

Placebo Comparator group

Description:

12 weeks of resistance training and placebo ingestion

Treatment:

Dietary Supplement: Placebo

Other: Resistance training