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Body and Cancer: a randomised phase III study in cancer patients undergoing chemotherapy - a supervised group exercise intervention versus standard care
ISRCTN ISRCTN05322922
DOI 10.1186/ISRCTN05322922
ClinicalTrials.gov identifier
EudraCT number
Public title Body and Cancer: a randomised phase III study in cancer patients undergoing chemotherapy - a supervised group exercise intervention versus standard care
Scientific title
Acronym BCIII
Serial number at source N/A
Study hypothesis The hypothesis to be tested is that the outcomes - health benefits - in the intervention group is better than in the control group.
Lay summary
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
Countries of recruitment Denmark
Disease/condition/study domain Oncological and haematological cancer patients undergoing chemotherapy
Participants - 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
Participants - exclusion criteria 1. Brain metastases
2. Bone metastases
3. Thrombocytopenia
4. Cardiovascular symptoms-cardial insufficiencies
5. No recent myocardial infarct
6. Normal blood pressure
Anticipated start date 01/10/2003
Anticipated end date 01/03/2007
Status of trial Completed
Patient information material
Target number of participants 250
Interventions 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).
Primary outcome measure(s) 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 measure(s) 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
Sources of funding 1. The Danish Cancer Society (Denmark)
2. The Lundbeck Foundation (Denmark)
3. The Novo Nordic Foundation (Denmark)
4. The Ministry of Culture Committee on Sports Research (Denmark)
5. The Copenhagen University Hospital (Denmark)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19826172
Contact name Prof  Lis  Adamsen
  Address The University Hospitals Centre for Nursing and Care Research (UCSF)
Copenhagen University Hospital
Department 7331
Blegdamsvej 9
  City/town Copenhagen
  Zip/Postcode DK-2100
  Country Denmark
  Tel +45 35457336
  Fax +45 35457399
  Email lisadams@ucsf.dk
Sponsor The University Hospitals Centre for Nursing and Care Research (UCSF) (Denmark)
  Address The Copenhagen University Hospital
Department 7331
Blegdamsvej 9
  City/town Copenhagen
  Zip/Postcode DK-2100
  Country Denmark
  Tel +45 35457336
  Fax +45 35457399
  Email lisadams@ucsf.dk
  Sponsor website: http://www.ucsf.dk/
Date applied 05/07/2007
Last edited 02/11/2009
Date ISRCTN assigned 13/08/2007
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