ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000085572

Ethics application status

Approved

Date submitted

3/01/2015

Date registered

2/02/2015

Date last updated

20/11/2018

Date data sharing statement initially provided

20/11/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Randomised Controlled Clinical Trial of a Supervised EXErcise Program in Patients with Lymphoma treated with Chemotherapy

Scientific title

Randomised Controlled Clinical Trial to evaluate the effect of a Supervised EXErcise Program on Quality of Life and deliverability of chemotherapy in Patients with Lymphoma treated with chemotherapy.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

EXEL Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Lymphoma

Condition category

Condition code

Cancer

Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Cancer

Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants undergo an initial assessment where an accredited exercise physiologist designs an individually tailored exercise program. Sessions are conducted twice weekly for a total of 20 sessions. All sessions are conducted within a group setting with a maximum number of 6 individuals under the guidance and supervision of an accredited exercise physiologist.
The exercise program will include both aerobic and resistance training. Although prior observational exercise intervention studies have focused on aerobic physical activity alone, our study will involve a combination of both aerobic and resistance training as the latter has been shown to have a positive effect on the performance of tasks required for everyday function.
Initial sessions will be of 20 minutes duration with 5-minute warm up and cool down periods. The sessions are classified as light in intensity with an aim to achieve 40-50% of heart rate reserve or a rate of perceived exertion (RPE) of 10-12. Subsequent sessions will gradually increase in duration (by 5 to 10 minutes) and intensity to a maximum of 45 minutes, with a 40:60 ratio of aerobic training to resistance training. It is recognized that some participants may achieve the training goals earlier but progression will adhere strictly to the American College of Sports Medicine Guidelines.

Aerobic

Aerobic exercises primarily consist of treadmill or upright/recumbent cycling. Aerobic activities are usually 5 – 15 min duration depending on Rating of Perceived Exertion (RPE) or fatigue levels. Intensity is gradually progressed i.e. speed or resistance to support cardio- respiratory improvements. Rowing or Elliptical trainers are also available and may be considered as an alternative.

Resistance Training

All major muscle groups are exercised and we utilise pin loaded weights machines to ensure safe and effective technique. The participants commence at 75% or their 1 RM score and the resistance is gradually increased and capacity/strength improves. Typically 2 – 3 sets or 10 – 12 repetitions, although can be modified by Exercise Physiologist to suit individual.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

Patients randomised to the control arm will receive standard care that includes general health education materials regarding nutrition and physical activity, both of which are published by the Cancer Council of New South Wales and are available on their website: http://www.cancer.org.au/home.htm.

Control group

Active

Outcomes

Primary outcome [1]

Patient reported health related quality of life as assessed by EORTC QLC C-30, HADS, Fact-An, FACT-C, FSFI and IIEF

Timepoint [1]

Baseline, 6 weeks, 12 weeks, 6 months, 12 months.

Secondary outcome [1]

Deliverability of chemotherapy as assessed by scheduled and actual completion of prescribed chemotherapy dose and schedule.

Timepoint [1]

At end of chemotherapy treatment.

Secondary outcome [2]

Emotional well-being, including mood at the completion of the structured exercise program, as assessed by EORTC QLC C-30, HADS, Fact-An, FACT-C, FSFI and IIEF Patient reported health related quality of life tools.

Timepoint [2]

Completion of exercise program

Eligibility

Key inclusion criteria

Patients with all of the following criteria will be eligible for enrolment:
a) Aged between 18 and 80 years with biopsy-proven diagnosis of lymphoma, both Hodgkin and non-Hodgkin.
b) Recommended to have systemic chemotherapy with or without external beam radiotherapy, with curative intent.
c) Need to have at least half of their recommended number of chemotherapy treatment cycles remaining.
d) ECOG level 0-2 with adequate cardio-respiratory and musculoskeletal function to participate in a regular exercise program as determined by the consultant physician/investigator.
e) Ability to read and understand the Patient Information Document and Consent Form with provision of verbal and written consent. Willingness and ability to comply with the specified intervention protocol, follow-up visits and all necessary investigations.

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients with any of the following criteria are not eligible for enrolment:
a) Recommended to either observation or chemotherapy with palliative intent.
b) Psychiatric disorders which impair ability to give verbal and written consent.
c) ECOG level 3-4

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

For continuous variables the demographic data will be summarised as: number, mean, standard deviation, minimum, and maximum for continuous variables for the total sample and for subgroups of baseline prognostic factors.

For categorical variables the demographic data will be summarised as tables of frequencies, and percentages for the total sample, and for subgroups of baseline prognostic factors.

The EORTC QLQ C-30 domains will be scaled to range from 0-100 where zero corresponds to the minimum possible score, and 100 to the maximum possible score.

The continuous variables, such as EORTC QLQ C-30 domains, will be analysed by analysis of covariance (ANCOVA) for repeated measurements with the baseline score as the covariate. The repeated measurements will be the scores at 6 and 12 weeks. The assumptions of the ANCOVA are that the residuals are Normally distributed with a constant variance. These assumptions will be assessed graphically. If necessary, rectification of the transformations will be applied.

The variables of: Completion of prescribed chemotherapy dose and schedule; Duration of hospitalisation; Disease status; Progress DEXA scan will be performed at the 12-month assessment will be summarised by treatment group.

The distribution of time to event variables, such as overall survival, will be graphed with Kaplan-Meier survival curves. The distributions of the treatment group will be compared with the log-rank test. The survival distributions for each treatment group will be summarised with number of patients, number of deaths, medians, and 95% CI, if the median is reached, or the proportion of patients surviving in each treatment group at 6 and 12 months post treatment. The hazard ratio and 95% CI will compare the hazard functions between the two treatment arms.

Sample size
A key consideration in determining the sample size is to ensure that the probability of a Type I error equals 0.05 under the assumption that the null hypothesis is true. In order to achieve such a property with 2 joint primary efficacy variables a Bonferroni adjustment will be applied, so the level of significance will be set to 0.025 for each of the joint primary efficacy variables.

For the EORTC QLQ C-30 physical functioning domain, the standard deviation was estimated to be 15 points on a scale from 0-100. A 15% improvement in the physical functioning domain was therefore judged to be clinically important. Given the following settings: level of significance 0.025, 2-sided test, standard deviation of 15 units, and a mean difference of 8 units, then a sample size of 89 patients per arm would provide a power of 90%. The sample size was increased by 15% to 104 to allow for early withdrawals.

The sample size calculation is similar for the 6MWT. The standard deviation is set to 100 metres with the mean difference to 60 metres, signifying a 15% improvement relative to the comparator group.

The total sample size will therefore be 208 patients.

Recruitment

Recruitment status

Stopped early

Data analysis

No data analysis planned

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

5/11/2014

Actual

3/11/2014

Date of last participant enrolment

Anticipated

7/11/2016

Actual

8/06/2016

Date of last data collection

Anticipated

Actual

28/06/2017

Sample size

Target

208

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St George Hospital - Kogarah

Recruitment postcode(s) [1]

2217 - Kogarah

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St George Hospital - Public

Address [1]

Gray Street,
Kogarah
NSW, 2217

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Fernando Roncolato

Address

St George Hospital
Gray Street,
Kogarah
NSW, 2217

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Yaw Chin

Address [1]

St George Hospital
Gray Street
Kogarah NSW
2217

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Seslhd Human Research Ethics Commitee

Ethics committee address [1]

Research Support Office G71
East Wing Edmund Blacket Building
Prince of Wales Hospital 
Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/05/2014

Approval date [1]

22/07/2014

Ethics approval number [1]

AU/th948110

Summary

Brief summary

The EXEL study will look at the effects of combining a structured exercise program with chemotherapy in patients with lymphoma to see whether adding exercise to a chemotherapy treatment schedule can be accomplished safely and practically. 

Who is it for? 
You may be eligible to join this study if you are aged between 18 and 80 years and have a biopsy-proven diagnosis of lymphoma, both Hodgkin and non-Hodgkin. You should also be recommended to have systemic chemotherapy with or without external beam radiotherapy, with curative intent. 

Study details 
Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard care which includes general health education materials regarding nutrition and physical activity, in conjunction with their prescribed chemotherapy/radiotherapy treatment. Participants in the other group will undergo a structured exercise program.  All participants will be asked to complete a number of questionnaires at the beginning of the study, then at the 6 week, 12 week, 6 month and 12 month (completion of the study) time points. This information will help us evaluate whether regular supervised exercise in addition to chemotherapy improves the quality of life and sense of wellbeing during and after chemotherapy.

This study will also look at whether adding an exercise program to chemotherapy helps increase the ability of patients to receive the prescribed dose of chemotherapy treatment in the required treatment time frame. A number of study procedures will be performed when you start your participation in the study. These include:

Health status assessment – your doctor will collect clinical information about your medical history and your current level of exercise. You will also be asked to complete a number of written questionnaires that look at different aspects of your wellbeing and quality of life. This will take approximately 15 minutes.

Physical examination – your blood pressure and heart rate will be checked. Your weight, height and waistline will also be measured. You will also perform three short walking, strength and balance tests. This will take approximately 15 minutes to complete.

Blood tests – this is to check the levels of different blood cells and important vitamins and minerals in your body. Your liver and kidney function, markers of inflammation and lymphoma activity and levels of immune proteins will also be assessed. This test is done only at the beginning of the study.
ECG (electrocardiogram) – this test records the electrical activity of your heart to ensure that you have a normal heart rhythm. This procedure takes about 15 minutes and is painless. This test is done only at the beginning of the study.
Bone mineral density assessment (DEXA scan) – this is a specialised X-ray scan that tests overall bone strength and risk of fractures. X-rays of two different strengths are passed through the tissues of the body and depending on the density of the tissues. This scan takes 5-10 minutes to complete and is painless. This test is done at the beginning and the end of the study.

The exercise program includes:

Aerobic

Aerobic exercises primarily consist of treadmill or upright/recumbent cycling. Aerobic activities are usually 5 – 15 min duration depending on Rating of Perceived Exertion (RPE) or fatigue levels. Intensity is gradually progressed i.e. speed or resistance to support cardio- respiratory improvements. Rowing or Elliptical trainers are also available and may be considered as an alternative.

Resistance Training

All major muscle groups are exercised and we utilise pin loaded weights machines to ensure safe and effective technique. The participants commence at 75% or their 1 RM score and the resistance is gradually increased and capacity/strength improves. Typically 2 – 3 sets or 10 – 12 repetitions, although can be modified by Exercise Physiologist to suit individual.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Fernando Roncolato

Address

St. George Hospital
Gray Street
Kogarah, NSW
2217

Country

Australia

Phone

+61 2 9113 1111

Fax

+61 2 9113 3958

fernando.roncolato@sesiahs.health.nsw.gov.au

Contact person for public queries

Name

Fernando Roncolato

Address

St. George Hospital
Gray Street
Kogarah, NSW
2217

Country

Australia

Phone

+61 2 9113 1111

Fax

+61 2 9113 3958

fernando.roncolato@sesiahs.health.nsw.gov.au

Contact person for scientific queries

Name

Fernando Roncolato

Address

Haematology Department
St. George Hospital
Gray Street
Kogarah, NSW
2217

Country

Australia

Phone

+61 2 9113 1111

Fax

+61 2 9113 3958

fernando.roncolato@sesiahs.health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Undecided

No/undecided IPD sharing reason/comment

TRIAL WAS DISCONTINUED

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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