Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer

NCT03066271 | Unknown

• 2 other identifiers: JRTEH-16048479
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the feasibility and the effect of daily, individual, supervised and structured exercise training before radiotherapy in patients diagnosed with Non-Small Cell Lung Cancer. Primary outcome is maximal oxygen uptake (VO2peak). The hypotheses are that patients who undergo daily exercise training will increase VO2peak, functional capacity (measured by 6-minute walk test (6MWD)) and lung function (forced expired volume in one second (FEV1)).

Conditions

Non-Small Cell Lung Cancer Stage; Chemoradiation

Keywords

Aerobic exercise; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum oxygen uptake - VO2peak

  The primary outcome will be VO2peak, assessed with an aerobic capacity (VO2peak) incremental cycle ergometer test performed on a Monark ergometer 839E cycle. At baseline, human physiology students will carry out the incremental cycle test. A physiotherapist who is blinded to the groups wherein the patients are allocated will carry out the posttest. The test consist of a warm-up phase at 10-50 w. After warm-up the load increases by 5-10 w every 60 sec until exhaustion or a possible symptom limitation (e.g. dizziness, sudden pain, vomiting sensation). To analyze the expired gases patients are going to wear a Hans Rudolf Mask during the test. Expired gases will be analyzed continuously by a metabolic breath-by-breath analysis and calculated as an average over 15 sec using the Oxycon Pro. Jaeger measurement system.

  Change from baseline at 7 weeks

Secondary Outcomes (10)

• Functional capacity

  Baseline and 7 weeks

• Forced Expiratory Volume in one second

  Baseline and 7 weeks

• Lung Function

  Baseline and 7 weeks

• Hypoxia in tumor

  Baseline and 7 weeks

• Stroke volumen

  Baseline, selected test samples during training intervention and 7 weeks

Other Outcomes (5)

• Overall survival rate

  26 weeks and 52 weeks

• Physical Activity

  Change from baseline at 7 weeks

• Quality of life and wellbeing

  Change from baseline at 7 weeks

Study Arms (2)

Exercise + usual care

EXPERIMENTAL

The supervised exercise training is carried out on a ergometer cycle as individual daily (mon-fri) training and each exercise training session consists of 20min. The training comprised a warm-up phase followed by 3 exercise phases. Warm-up consisted of 5min light stationary cycling, adjusted to 50-60% of the patients peak power output determine at the incremental cycle test (iPPO). The first exercise phase comprised of 5min interval training consisting of 5x30 sec intervals at 80-95% of the patient's iPPO. Between each interval, there is a 30 sec pause. The 2nd exercise phase consisted of 5min continuous cycling at an intensity equaling 80% of the patient's iPPO. The 3rd exercise phase was similar to the first exercise phase. Intensities increased progressively from the first week to the last week (from 50%, 80% and 70% of iPPO according to the three different phases to 60%, 95% and 80 % of iPPO respectively.

Other: Exercise +

Control - usual care

EXPERIMENTAL

The patients randomized to the control group received no training but will be wearing the activity tracker during the intervention.

Other: Control +

Interventions

Exercise + OTHER

Usual care

Exercise + usual care

Control + OTHER

Usual care

Control - usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with NSCLC who are treated with concomitant chemo- and radiotherapy.
• Age: \> 18 year
• WHO performance status 0-1

You may not qualify if:

• Patients with any symptoms or circumstances that advise against physical activity.
• Symptomatic heart disease e.g. arrhythmia or myocardial infarction within the last three months.
• Congestive heart failure
• Patients who do not read and speak Danish.
• Brain or bone metastases;
• Prolonged bone marrow suppression
• Anti-coagulant treatment
• Inability to provide informed consent.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator

Study Sites (1)

University Hospital of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Morten Quist, Post. doc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 28, 2017
• Study Start: April 3, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 28, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)