NCT01025518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

December 2, 2009

Last Update Submit

November 28, 2016

Conditions

Head and Neck Neoplasms

Keywords

Head and Neck NeoplasmsResistance trainingMuscle massFunctional capacity

Outcome Measures

Primary Outcomes (1)

  • Muscle mass and muscle strength

    13 weeks

Secondary Outcomes (1)

  • Functional capacity

    13 weeks

Study Arms (2)

resistance training and dietary supplement

EXPERIMENTAL
Other: Resistance trainingDietary Supplement: Protein and creatine

Resistance training and placebo ingestion

PLACEBO COMPARATOR

12 weeks of resistance training and placebo ingestion

Other: Resistance trainingDietary Supplement: Placebo

Interventions

Resistance trainingOTHER

12 weeks of resistance training in combination with protein and creatine or placebo ingestion

Resistance training and placebo ingestionresistance training and dietary supplement
Protein and creatineDIETARY_SUPPLEMENT

30 g of protein with each training session, 5 g of creatine pr day

Also known as: In2Zyme WP80 and In2Zyme Biodrive 1
resistance training and dietary supplement
PlaceboDIETARY_SUPPLEMENT

Maltodextrine

Resistance training and placebo ingestion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • other malignant diseases
  • pregnancy
  • undergoing systematic resistance training or creatin ingestion
  • Alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Experimental Clinical Oncology, Aarhus University Hospital

Aarhus, Region Midt, 8000, Denmark

Location

Dept. of Experimental Clinical Oncology

Aarhus, 8000, Denmark

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Resistance TrainingProteinsCreatine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAmino Acids, Peptides, and ProteinsGuanidinesAmidinesOrganic ChemicalsAmino Acids

Study Officials

  • Jens Overgaard, Professor, MD

    DAHANCA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

DK(2)