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

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training
Protein and creatine
Placebo
Sponsored by
Danish Head and Neck Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Neoplasms focused on measuring Head and Neck Neoplasms, Resistance training, Muscle mass, Functional capacity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept. of Experimental Clinical Oncology, Aarhus University Hospital
  • Dept. of Experimental Clinical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

resistance training and dietary supplement

Resistance training and placebo ingestion

Arm Description

12 weeks of resistance training and placebo ingestion

Outcomes

Primary Outcome Measures

Muscle mass and muscle strength

Secondary Outcome Measures

Functional capacity

Full Information

First Posted
December 2, 2009
Last Updated
November 28, 2016
Sponsor
Danish Head and Neck Cancer Group
Collaborators
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
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1. Study Identification

Unique Protocol Identification Number
NCT01025518
Brief Title
DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Head and Neck Cancer Group
Collaborators
Danish Center for Interventional Research in Radiation Oncology (CIRRO)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Head and Neck Neoplasms, Resistance training, Muscle mass, Functional capacity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
resistance training and dietary supplement
Arm Type
Experimental
Arm Title
Resistance training and placebo ingestion
Arm Type
Placebo Comparator
Arm Description
12 weeks of resistance training and placebo ingestion
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
12 weeks of resistance training in combination with protein and creatine or placebo ingestion
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein and creatine
Other Intervention Name(s)
In2Zyme WP80 and In2Zyme Biodrive 1
Intervention Description
30 g of protein with each training session, 5 g of creatine pr day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrine
Primary Outcome Measure Information:
Title
Muscle mass and muscle strength
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Functional capacity
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Overgaard, Professor, MD
Organizational Affiliation
DAHANCA
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Experimental Clinical Oncology, Aarhus University Hospital
City
Aarhus
State/Province
Region Midt
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Dept. of Experimental Clinical Oncology
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Links:
URL
http://www.dahanca.dk
Description
Danish Head and Neck Cancer Group

Learn more about this trial

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

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