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Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial


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

Thank you

Trial Information

Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial


Inclusion Criteria:



- Histologically diagnosed with squamous cell carcinomas of the larynx (no glottis
stage I+II), pharynx, oral cavity or in lymph nodes from an unknown primary tumour
(stage I-IV and tumour node metastasis (TNM) classification, UICC, Geneva, 1987)

- Terminated curative radiotherapy treatment with/without chemotherapy;

- No metastases

- Complete tumour remission

- No current or previous malignancies that could prevent participation and training

- No excessive alcohol intake (men > 21 and women > 14 units/wk)

- No recent systematic resistance training or creatine ingestion (within 2 months)

- If woman, not pregnant

- WHO performance status of 0-1

- No psychological, social or geographical conditions that could disturb participation

- Written consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Body composition

Outcome Description:

Lean body mass and fat mass assessed by DEXA scanning

Outcome Time Frame:

Baseline, 3 months and 6 months

Safety Issue:

No

Principal Investigator

Jens Overgaard, Prof., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Danish Head and Neck Cancer Group

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

DAHANCA 25B

NCT ID:

NCT01509430

Start Date:

October 2011

Completion Date:

April 2013

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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