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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025518
• Other study ID #: DAHANCA 25A
• Secondary ID: CIRRO-IP010309Et
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: November 28, 2016
• Start date: September 2009
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: Danish Head and Neck Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Other:
• Resistance training
12 weeks of resistance training in combination with protein and creatine or placebo ingestion

Dietary Supplement:
• Protein and creatine
30 g of protein with each training session, 5 g of creatine pr day
• Placebo
Maltodextrine

Locations

Country	Name	City	State
Denmark	Dept. of Experimental Clinical Oncology	Aarhus
Denmark	Dept. of Experimental Clinical Oncology, Aarhus University Hospital	Aarhus	Region Midt

Sponsors (2)

Lead Sponsor	Collaborator
Danish Head and Neck Cancer Group	Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass and muscle strength		13 weeks	No
Secondary	Functional capacity		13 weeks	No

External Links

•   Danish Head and Neck Cancer Group