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

Chemoradiation Clinical Trial

— PRIME  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03066271
• Other study ID #: JRTE
• Secondary ID: H-16048479
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

Description:

Pre intervention screening: Each patient was screened by a clinical nurse specialist prior to participating in the study. Before baseline and post test the patient was screened by a research physiotherapist and/or human physiology students. If one of the following criteria were met, the patient was prohibited from being tested on that day: diastolic blood pressure <45 or >95, heart rate (HR) at rest >115/min, temperature > 38 0C, respiratory rate at rest >30/min, infection requiring treatment, fresh bleeding, total leucocyte count <1.0 109/L or platelets <50 109/L.

Control - Usual care: The patients randomized to the control group received no training but conducted baseline and post test (6MWD, spirometry, VO2peak and questionnaires) just as the intervention group. Furthermore, patients in control were equipped with a Garmin vivo-smart HR® activity tracker every day in 24h during the course of radiotherapy treatment.

Intervention - The patients randomized to the intervention group received daily training and conducted baseline and post test (6MWD, spirometry, VO2peak and questionnaires). Furthermore, patients were equipped with a Garmin vivo-smart HR® activity tracker every day in 24h during the course of radiotherapy treatment.

The supervised daily training was carried out individually and each session had a duration of 20 minutes before patients individual prescribed radiotherapy. Training was conducted at National Hospital of Denmark: Department of Radiation Oncology , section 3981, entry 39. supervised by a research physiotherapist and/or human physiology students.

Statistical analysis sample size: According to the sample size the calculation is performed on the basis of alteration in VO2peak from the study "EXHALE" (55 patients who completed a 6 weeks training period). The calculation is based on an increase of 200 ml/min in VO2peak for patients in the intervention group (SD = 2,48) and it is assumed that the patients in the control group will have a reduction of 100 ml/min (SD = 2,48). Assumptions for calculation of patient numbers are as follows: Type 1 error 0.05, type 2 error 0.20, SD 2.48.

This leads to a total number of 24 patients (12 in each arm). A drop-out rate of 40% is included. Therefore another 16 patients is added, which gives a sample size of 40 patients (20 in each arm).

Data entry is carried out in the Open Clinica and data analyses will be performed using the computer programs R-Studio/R and SPSS. Data from questionnaires will be analyzed by SPSS. All other data will be analyzed by R.

Differences between groups will be analyzed by an unparried t-test whereas differences within groups will be analyzed by a parried t-test. All categorical data are analyzed using the Pearson χ2 tests. Other data (e.g., from questionnaires) are analyzed using logistic regression and chi square or Mantel Haenzel test. Significance level is set at 0.05.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with NSCLC who are treated with concomitant chemo- and radiotherapy.

• Age: > 18 year

• WHO performance status 0-1

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Chemoradiation
• Lung Neoplasms
• Non-Small Cell Lung Cancer Stage

Intervention

Other:
• Exercise +
Usual care
• Control +
Usual care

Locations

Country	Name	City	State
Denmark	University Hospital of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival rate	Overall survival be measured from inclusion until death or 26 weeks or 52 weeks	26 weeks and 52 weeks
Other	Physical Activity	Physical Activity - International Physical Activity Questionnaire Long (IPAQ-L).	Change from baseline at 7 weeks
Other	Quality of life and wellbeing	Quality of life and wellbeing - Functional Assessment of Cancer Therapy - Lung (FACT-L).	Change from baseline at 7 weeks
Other	Anxiety and depression	Anxiety and depression - Hospital Anxiety and Depression Scale (HAD)	Change from baseline at 7 weeks
Other	Activity Data	Steps, distance and intensity minutes measured by Garmin vivo-smart HR® activity tracker.	Every day in 24h during the course of radiotherapy treatment
Primary	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	Functional capacity	Functional capacity is measured by a 6 MWD test. The test is carried out over a pre-measured distance of 20 meters, in compliance with the American Thoracic Society (ATS) statement. After the test the patients will rate the breathing on Borg Scale for dyspnea.	Baseline and 7 weeks
Secondary	Forced Expiratory Volume in one second	Forced Expiratory Volume in 1 second (FEV1) is measured using a standard spirometry in a standing position with the use of the Oxycon Pro, Jaeger measurement system.	Baseline and 7 weeks
Secondary	Lung Function	Ventilation (VE), Breath frekvens (BF) and tidal volume (Vt) measured by indirect calorimetry.	Baseline and 7 weeks
Secondary	Hypoxia in tumor	The extent of hypoxia in human tumors assessed by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).	Baseline and 7 weeks
Secondary	Stroke volumen	Stroke volumen will be measured by a ClearSight System	Baseline, selected test samples during training intervention and 7 weeks
Secondary	Cardiac output	Cardiac output will be measured by a ClearSight System	Baseline, selected test samples during training intervention and 7 weeks
Secondary	Systemic vascular resistance	Systemic vascular resistance (SVR) will be measured by a ClearSight System	Baseline, selected test samples during training intervention and 7 weeks
Secondary	Safety: Sports-injury, Pain, Neuropathies, Nausea/vomiting, Fatigue etc.	Serious adverse events and adverse events (e.g.)sports-injury, pain, neuropathies, nausea/vomiting, fatigue, neutropenia, fever, diarrhoea, hospitalisation and infection	Baseline, during intervention and 7 weeks
Secondary	Respiratory exchange ratio (RER)	To analyze the expired gases patients are going to wear a Hans Rudolf Mask during a incremental cycle ergometer test. Expired gases will be analyzed continuously by a metabolic breath-by-breath analysis and calculated as an average over 15 seconds using the Oxycon Pro. Jaeger measurement system.	Change from baseline at 7 weeks
Secondary	Rated Perceived Exertion (RPE) Scale	In the final seconds of the incremental cycle ergometer test self-perceived exertion perception and dyspnoea will be noted.	Change from baseline at 7 weeks