FatiguePhase 3NCT01035203
Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue
A Phase 3 study testing Exercise and Cognitive behavioural therapy in people with Fatigue and Mood, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatigue, Mood, Maximal Oxygen Uptake
- What is being tested?
- Exercise and Cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Sep 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Histologically confirmed neoplastic disease
- Treatment (chemotherapy or radiation) completed.
- No treatment in the previous 4 weeks
- Ability to understand written German
Who cannot join
- Health conditions which can be aggravated by exercise
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Sports Medicine
Berlin, State of Berlin, 14167
Fernando Dimeo, MD, +493084452098, fernando.dimeo@charite.de
Susanne Effenberger, +493084454834, susanne.effenberger@charite.de
About this study
Official title: Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue
The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.
- Conditions
- Fatigue, Mood, Maximal Oxygen Uptake
- Being tested
- Exercise, Cognitive behavioural therapy
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Endurance exercise 3 times weekly for 45 minutes, 4 weeks long
Cognitive behavioural therapyBehavioural
Teaching of techniques to reduce fatigue and to improve stamina
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioural therapy | Active comparator | Not described Receives: Behavioral: Cognitive behavioural therapy |
| Exercise | Experimental | Endurance training (walking on a treadmill) 3 x weekly for 4 weeks Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue scores on the Brief Fatigue Inventory (BFI)
Measured: 4 weeks
Secondary outcomes (2)
Maximal oxygen uptake (VO2max) on a treadmill stress test.
Measured: 4 weeks
Scores on the HADS (Hospital Anxiety and Depression Scale)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035203
- Sponsor's protocol ID
- 176-25/kmo
- Status last verified
- Mar 2010
- First submitted
- 17 Dec 2009
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue
- ClinicalTrials.gov ID
- NCT01035203
- Acronym / sponsor ID
- 176-25/kmo
- Conditions
- Fatigue, Mood, Maximal Oxygen Uptake
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 18 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural therapy | Active comparator | Behavioral: Cognitive behavioural therapy |
| Exercise | Experimental | Behavioral: ExerciseEndurance training (walking on a treadmill) 3 x weekly for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70
- Histologically confirmed neoplastic disease
- Treatment (chemotherapy or radiation) completed.
- No treatment in the previous 4 weeks
- Ability to understand written German
Key exclusion criteria (1 listed)
- Health conditions which can be aggravated by exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseEndurance exercise 3 times weekly for 45 minutes, 4 weeks long | Behavioural | Exercise |
| Cognitive behavioural therapyTeaching of techniques to reduce fatigue and to improve stamina | Behavioural | Cognitive behavioural therapy |
Primary outcome
Fatigue scores on the Brief Fatigue Inventory (BFI)
Time frame: 4 weeks
2 secondary outcomes
Maximal oxygen uptake (VO2max) on a treadmill stress test.
Time frame: 4 weeks
Scores on the HADS (Hospital Anxiety and Depression Scale)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise and Cognitive behavioural therapy in people with Fatigue and Mood, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Dimeo, MD (+493084452098, fernando.dimeo@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue scores on the Brief Fatigue Inventory (BFI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2010.