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Progressive Resistance Training Program in Head and Neck Cancer Patients

23 september 2015 uppdaterad av: Julie Gehl, Herlev Hospital

Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

12 patients with head and neck cancer will be recruited to this trial. Entering a 12-week PRT program which will start one week before radiotherapy. The tested training program is a 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body. The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. This approach has previously been used for exercise interventions for lung cancer patients at our facility, and was highly appreciated by the patients.

In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered on a weekly basis: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake.

Physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 2, 5, 9 and 13 months follow-up. At similar time points dual energy x-ray absorptiometry (DXA) scans for body composition will be performed using a Lunar iDXA (GE Healthcare).

Blood samples will be drawn at baseline, an additional three times during the first 6 weeks and then weekly in relation to training sessions, and at 2, 5, 9 and 13 months follow-up.

Patient reported quality of life (EORTC Quality of Life Questionaire (QLQ)-C30 and QLQ-H&N35) will be registered at baseline, after 12-weeks PRT and during 5 and 13 months follow-up.

Study duration is expected to be 7 months for the pilot-trial, with a follow-up of additional 13 months after the last patient has completed the intervention.

Studietyp

Interventionell

Inskrivning (Faktisk)

12

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Herlev, Danmark, 2730
        • Dept. of Oncology

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Progressive resistance training
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).
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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility
Tidsram: up to 7 months

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in LBM
Tidsram: up to 20 months
Whole body LBM will be determined using dual energy x-ray absorptiometry (DXA).
up to 20 months
Weight loss
Tidsram: up to 20 months
Patient will be weighed weekly during the 12-week PRT program; afterwards at each follow-up (2, 5, 9, and 13 months)
up to 20 months
Number of patients with side-effects to treatment
Tidsram: up to 7 months
Side-effects will be registered using Common Terminology Criteria for Advers Events v4.0 (CTCAE).
up to 7 months
Quality of Life
Tidsram: Up to 20 months
Up to 20 months
Change in physical function and strength
Tidsram: Up to 20 months

Change in muscle strength will be evaluated by 1 repetition maximum test (1RM) measured in kg.

Change in muscle power will be evaluated by Nottingham Power Rig and measured in watts and watt/kg.

Change in physical function will be evaluated by 30 second sit-to-stand test, arm curl test and stair climbing.

Up to 20 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Muscle biopsies
Tidsram: up to 7 months
In order to establish energy-reserves in the muscles
up to 7 months
Blood samples
Tidsram: Up to 20 months
In order to identify systemic factors released during exercise
Up to 20 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Huvudutredare: Julie Gehl, ph.d., Herlev Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2014

Primärt slutförande (Faktisk)

1 september 2015

Avslutad studie (Faktisk)

1 september 2015

Studieregistreringsdatum

Först inskickad

13 februari 2014

Först inskickad som uppfyllde QC-kriterierna

20 februari 2014

Första postat (Uppskatta)

21 februari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 september 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2015

Senast verifierad

1 september 2015

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Progressive resistance training

3
Prenumerera