Condition category
Cancer
Date applied
05/07/2007
Date assigned
13/08/2007
Last edited
02/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ucsf.dk/

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

  1. 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.

Additional files

Editorial Notes