Contact information
Type
Scientific
Primary contact
Prof Lis Adamsen
ORCID ID
Contact details
The University Hospitals Centre for Nursing and Care Research (UCSF)
Copenhagen University Hospital
Department 7331
Blegdamsvej 9
Copenhagen
DK-2100
Denmark
+45 35457336
lisadams@ucsf.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
BCIII
Study hypothesis
The hypothesis to be tested is that the outcomes - health benefits - in the intervention group is better than in the control group.
Ethics approval
Approval received from:
1. The Scientific Committees of the Copenhagen and Frederiksberg municipalities on the 24th June 2003 (ref: 01-273/00)
2. The Danish Data Protection Agency on the 1st August 2003 (ref: 2000-41-0-149)
Study design
Single-centre randomised prospective open label trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Oncological and haematological cancer patients undergoing chemotherapy
Intervention
Cancer patients will be recruited from the Copenhagen University Hospital, Department of Oncology, Department of Haematology and from The Herlev Hospital, Department of Oncology.
After informed consent and baseline measures randomisation (Clinical Internet Trial Management System [CITMAS]). Data is anonymised using an ID-code and administrative data is kept in a separate database.
The intervention group:
The exercise intervention included four components:
1. Physical exercise (resistance and cardiovascular/fitness training)
2. Relaxation training
3. Body awareness training
4. Massage
The intervention took place in a specially designed workout room located at the Copenhagen University Hospital and was carried out over a six-week period, nine hours per week, in the mornings. Patients came in especially to participate in the exercise programme. On Mondays, Wednesdays and Fridays, the patients participated in physical exercise for 1.5 hours followed by 0.5 hours of relaxation. On Tuesdays, the programme included 1.5 hours of body awareness training followed by 0.5 hours of relaxation. Finally, on Mondays and Fridays, the patients received 0.5 hours of massage.
The different components of the programme constituted a total package, which implied that the patients could not select one activity in preference of another. Seven to ten patients of mixed gender were included in each group. Physiotherapists and a cancer nurse specialist supervised the programme. Pre-exercise screening was performed every second day before the high-intensity physical training.
If one of the following criteria were met, the patient was excluded from the physical training component of the programme on that specific day:
1. Diastolic blood pressure less than 45 mmHg or greater than 95 mmHg
2. Pulse at rest greater 100 beats per minute
3. Temperature greater than 38°C
4. Respiration frequency greater than 20 (number of respirations per minute)
5. Infection requiring treatment with antibiotics
6. Ongoing bleeding
7. Fresh petechiae
8. Bruises
9. Thrombocytes less than 50 x 10^9/l
10. Leucocytes less than 1.0 x 10^9/l
Heart rate was continuously monitored and measured by means of a wireless heart rate transmitter worn by the patients.
Control group:
Patients assigned to the control group received usual care from the health care team and completed outcome measures on the same time frame as the intervention group (no supervised exercise during a six-week period).
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Fatigue measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), measured at baseline, after six weeks and after three months.
Secondary outcome measures
1. Improvement in muscular strength, aerobic fitness measured using One Repetition Maximum (1RM), Maximal oxygen uptake (VO2max), measured at baseline and after six weeks
2. Improvement in quality of life measured using QLQ-C30, Functional Assessment Cancer Therapy-Anaemia (FACT-An), measured at baseline, after six weeks and after three months
3. Improvement in general well-being measured using Medical Outcomes Study 36-item Short Form (MOS SF-36), measured at baseline, after six weeks and after three months
4. Reduction in anxiety and depression measured using Hospital Anxiety and Depression Scale (HADS), measured at baseline, after six weeks and after three months
5. Physical activity level I - IV measured using the Saltin Scale, measured at baseline, after six weeks and after three months
Overall trial start date
01/10/2003
Overall trial end date
01/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. World Health Organization (WHO) performance stage score zero to one
2. A diagnosis of cancer (one month previously), admitted to hospital for out-patient chemotherapy
3. Received at least one series of chemotherapy
4. Previously undergone surgery and/or radiotherapy
5. Age 18 to 65 years inclusive
6. Residence in the Greater Copenhagen Council
7. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
250
Participant exclusion criteria
1. Brain metastases
2. Bone metastases
3. Thrombocytopenia
4. Cardiovascular symptoms-cardial insufficiencies
5. No recent myocardial infarct
6. Normal blood pressure
Recruitment start date
01/10/2003
Recruitment end date
01/03/2007
Locations
Countries of recruitment
Denmark
Trial participating centre
The University Hospitals Centre for Nursing and Care Research (UCSF)
Copenhagen
DK-2100
Denmark
Sponsor information
Organisation
The University Hospitals Centre for Nursing and Care Research (UCSF) (Denmark)
Sponsor details
The Copenhagen University Hospital
Department 7331
Blegdamsvej 9
Copenhagen
DK-2100
Denmark
+45 35457336
lisadams@ucsf.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
The Danish Cancer Society (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Lundbeck Foundation (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Novo Nordic Foundation (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Ministry of Culture Committee on Sports Research (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Copenhagen University Hospital (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19826172
Publication citations
-
Results
Adamsen L, Quist M, Andersen C, Møller T, Herrstedt J, Kronborg D, Baadsgaard MT, Vistisen K, Midtgaard J, Christiansen B, Stage M, Kronborg MT, Rørth M, Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial., BMJ, 2009, 339, b3410.