Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000167561
Ethics application status
Approved
Date submitted
8/02/2015
Date registered
20/02/2015
Date last updated
11/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of a physical activity program and typical advice about physical activity in cancer cachexia patients
Scientific title
The efficacy of physical activity program and typical advice about physical activity in improving the physical activity in cancer cachexia patients.
Secondary ID [1] 286129 0
NIL
Universal Trial Number (UTN)
U1111-1167-0458
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer Cachexia 294135 0
Cancer, Lung-Non small cell 294193 0
Cancer, Lung Small cell 294194 0
Condition category
Condition code
Cancer 294453 294453 0 0
Lung - Non small cell
Cancer 294454 294454 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants were included in exercise program had two session exercise per week for 12 weeks and supervised by expert physiotherapists. the program was tailored to the individual patient's level of physical activity. Program include Aerobic exercise, resistance exercise and flexibility exercise. All the program was done under direct supervision of physiotherapist. Exercise was done for two minutes at each station (6 stations), with a minute intermission/pause when the patient lifted to the later stationand duration of the exercise each session about 30 miutes including the warming-up whcih before starting the 6 stations.. The exercises were involved resistance exercise as standing push-up, chest and shoulders, step up , flexible exercise such as shoulder stretch and aerobic exercise. Aerobic exercise include walking for 10-20 minutes of an intensity of 40%-70% of predicted heart maximum rates or 8-13 on the 15-point Borg's scale for rating of perceived of exertion..Centre for Epidemiologic Studies Depression Scale (CES-D) Questionnaires, EuroQoL Group EQ-5D-5L Questionnaires for quality of life was used. Short Physical performance Battery test, Six-Minute Walk test where used.

All this intervention done under direct supervision pf expert physiotherapist with more than 10 years experience.
Intervention code [1] 291125 0
Lifestyle
Intervention code [2] 291126 0
Rehabilitation
Comparator / control treatment
Control group will not receive any intervention program.
Control group
Active

Outcomes
Primary outcome [1] 294240 0
To determine the effects of an exercise program, compared with the usual care on the QoL (Quality of life) in cancer cachexia patients with underlying stage IV NSCLC.
Timepoint [1] 294240 0
4, 8 and 12 weeks
Primary outcome [2] 294295 0
The effect of exercise program compared with the usual care on physical performance in cancer cachexia patients with underlying stage IV NSCLC
Timepoint [2] 294295 0
Data will be collected at base line after 4 weeks from intervention, for both control and intervention group.
Secondary outcome [1] 312972 0
To study the effects of an exercise program compared with usual care on depression in the participants by questionnaire Centre for Epidemiologic Studies Depression Scale (CES-D-20).
Timepoint [1] 312972 0
12 weeks from baseline

Eligibility
Key inclusion criteria
Inclusion criteria was patients with cancer cachexia with a confirmed diagnosis of late-stage NSCLC.
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have the same type of cancer but do not have cancer cachexia.

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Interim analysis is to be conducted following the 1st 30 participants.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
5/02/2015
Actual
5/02/2015
Date of last participant enrolment
Anticipated
14/12/2017
Actual
10/04/2015
Date of last data collection
Anticipated
25/12/2017
Actual
15/10/2015
Sample size
Target
286
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 6638 0
Egypt
State/province [1] 6638 0
Cairo

Funding & Sponsors
Funding source category [1] 290704 0
University
Name [1] 290704 0
National Cancer Institute
Country [1] 290704 0
Egypt
Primary sponsor type
University
Name
National Cancer Institute
Address
National Cancer Institute
Fom El Khalid, Cairo 11796, Egypt
Country
Egypt
Secondary sponsor category [1] 289396 0
None
Name [1] 289396 0
No more secondary sponsor
Address [1] 289396 0
It was the primary sponsor
Country [1] 289396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294369 0
Institutional Review Board Decision
Ethics committee address [1] 294369 0
National Cancer Institute, Cairo University, Egypt.
Ethics committee country [1] 294369 0
Egypt
Date submitted for ethics approval [1] 294369 0
20/11/2014
Approval date [1] 294369 0
25/11/2014
Ethics approval number [1] 294369 0
201516009.7
Ethics committee name [2] 294370 0
National Cancer Institute
Ethics committee address [2] 294370 0
National Cancer Institute, Cairo University,Fom El Khalig, Cairo, Egypt, 11796.
Ethics committee country [2] 294370 0
Egypt
Date submitted for ethics approval [2] 294370 0
Approval date [2] 294370 0
25/11/2014
Ethics approval number [2] 294370 0
MD2010014012.3, IRB No IRB00004025, FWA No RWA00007284

Summary
Brief summary
A prospective two-armed randomised, controlled (RCT) pilot study was conducted on 30 participants (15 cases and 15 controls) to check the effects of a physical exercise program (12 weeks) compared to usual care on physical performance and quality of life in cancer cachexia patients with underlying stage IV non-small cell lung cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54746 0
Prof Wafa Taha
Address 54746 0
National Cancer Institute
Fom El Khalid, Cairo 11796, Egypt
Country 54746 0
Egypt
Phone 54746 0
+201222168097
Fax 54746 0
Email 54746 0
[email protected]
Contact person for public queries
Name 54747 0
Dr Prof Wafa Taha
Address 54747 0
Fom El Khalid Cairo 11796 National Cancer Institute, Cairo
Country 54747 0
Egypt
Phone 54747 0
+201222168097
Fax 54747 0
Email 54747 0
[email protected]
Contact person for scientific queries
Name 54748 0
Prof Wafa Taha
Address 54748 0
National Cancer Institute
Fom El Khalid, Cairo 11796, Egypt
Country 54748 0
Egypt
Phone 54748 0
+201222168097
Fax 54748 0
Email 54748 0
[email protected]

No information has been provided regarding IPD availability


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.