NCT02068950

Brief Summary

The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared to usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

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

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

1.6 years

First QC Date

February 13, 2014

Last Update Submit

September 23, 2015

Conditions

Head and Neck Cancer

Keywords

Head and neck cancerConcurrent chemoradiotherapyProgressive resistance trainingExerciseFeasibilityWeight lossLBMBody composition

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    The feasibility outcomes will be inclusion rate defined as the number of patients recruited from the number of eligible patients and completion rate defined as the number of participants able to complete the intervention. Adherence to the exercise intervention will be evaluated via patient-reported training logs.

    up to 7 months

Secondary Outcomes (5)

  • Change in LBM

    up to 20 months

  • Weight loss

    up to 20 months

  • Number of patients with side-effects to treatment

    up to 7 months

  • Quality of Life

    Up to 20 months

  • Change in physical function and strength

    Up to 20 months

Other Outcomes (2)

  • Muscle biopsies

    up to 7 months

  • Blood samples

    Up to 20 months

Study Arms (1)

Progressive resistance training

OTHER

12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand).

Behavioral: Progressive resistance training

Interventions

Progressive resistance trainingBEHAVIORAL

A 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body will be tested. Details of the program: 12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)

Progressive resistance training

Eligibility Criteria

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

You may qualify if:

  • Patients with head and neck squamous cell carcinoma
  • Candidates for concomitant chemoradiotherapy according to Danish Head and Neck Cancer Group (DAHANCA) guidelines.
  • Performance status 0-1
  • Expected to be able to complete the intervention, i.e. no major comorbidities or social issues that could compromise attendance.
  • At least 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Oncology

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMotor ActivityWeight Loss

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Julie Gehl, ph.d.

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, ph.d.

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 21, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

DK(1)