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


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Neoplasms

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Muscle mass and muscle strength

Outcome Time Frame:

13 weeks

Safety Issue:

No

Principal Investigator

Jens Overgaard, Professor, MD

Investigator Role:

Study Chair

Investigator Affiliation:

DAHANCA

Authority:

Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:

DAHANCA 25

NCT ID:

NCT01025518

Start Date:

September 2009

Completion Date:

January 2012

Related Keywords:

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

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