NeoplasmsNCT02647398
Study Comparing Two Strategies of Exercise in Breast and Colon Cancer Survivors and Their Impact on Fatigue
A study testing Vigorous aerobic training in people with Neoplasms and Fatigue, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Vigorous aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Sep 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65
- history of breast or colon cancer
- no evidence of disease
- end of treatment in the last five years
- able to understand the questionnaire PERFORM
- able to manage the accelerometer
Who cannot join
- mobility limitation
- treatment with beta-blockers
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, 28222
About this study
Official title: Randomized Study Comparing Two Strategies of Physical Activity in Long-term Breast and Colon Cancer Survivors and Their Impact on Fatigue
Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue.
Read the detailed description
Patients should have finalized their oncological treatment in the previous 5 years. The sample size (32 patients) was calculated to improve the perception of fatigue score from an anticipated initial 38 to a post-intervention 48.
The control arm consist of supervised strength training in two sessions per week with non-supervised international recommendations for aerobic exercise. The experimental arm will consist of supervised strength + resistance training in two sessions per week.
After evaluating the weekly physical activity through accelerometer, body composition through DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training according to a randomized assignment.
Secondary objectives include:
- cardiorespiratory fitness,
- quality of life;
- adherence to the training program;
- adherence to international recommendations,
- body composition,
- employment status
- Being tested
- Vigorous aerobic training
- Keywords
- Cancer survivors, training, exercise, cancer-related fatigue
- Medical subject headings
- Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigorous aerobic trainingBehavioural
Supervised vigorous aerobic training
| Study group | Role | What they receive |
|---|---|---|
| A: Supervised combined training | Experimental | INTERVENTION: Two supervised 75 min-vigorous aerobic training \& strength training Receives: Behavioral: Vigorous aerobic training |
| B: Supervised strength training | Active comparator | ACTIVE COMPARATOR: Two supervised 45-minute sessions of strength training \& Participants will be advised to comply with international recommendations of physical activity (150 min pf MVPA) Receives: Behavioral: Vigorous aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cancer related-fatigue
Measured: 4 months
Secondary outcomes (6)
Changes in cardiorespiratory fitness
measured through CPET
Measured: 4 months
Changes in quality of life
measured through EORTC QLQ C30
Measured: 4 months
adherence to the program
Measured: 4 months
adherence to international recommendations
measured by accelerometer
Measured: 4 months
Changes in body composition
measured by DEXA (Dual Energy X-Ray Absortiometry)
Measured: 4 months
Employment status
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Responsible party
- Principal investigator, Ana Ruiz-Casado, Puerta de Hierro University Hospital
- Investigators
- Itziar Pagola, PhD, Study director, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647398
- Sponsor's protocol ID
- PH-UEM-04
- Status last verified
- Apr 2018
- First submitted
- 3 Jan 2016
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Two Strategies of Physical Activity in Long-term Breast and Colon Cancer Survivors and Their Impact on Fatigue
- ClinicalTrials.gov ID
- NCT02647398
- Acronym / sponsor ID
- PH-UEM-04
- Keywords
- Cancer survivors, training, exercise, cancer-related fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 6 Jan 2016 (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.
Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue.
Detailed description
Patients should have finalized their oncological treatment in the previous 5 years. The sample size (32 patients) was calculated to improve the perception of fatigue score from an anticipated initial 38 to a post-intervention 48.
The control arm consist of supervised strength training in two sessions per week with non-supervised international recommendations for aerobic exercise. The experimental arm will consist of supervised strength + resistance training in two sessions per week.
After evaluating the weekly physical activity through accelerometer, body composition through DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training according to a randomized assignment.
Secondary objectives include:
- cardiorespiratory fitness,
- quality of life;
- adherence to the training program;
- adherence to international recommendations,
- body composition,
- employment status
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Supervised combined training | Experimental | Behavioral: Vigorous aerobic trainingINTERVENTION: Two supervised 75 min-vigorous aerobic training \& strength training |
| B: Supervised strength training | Active comparator | Behavioral: Vigorous aerobic trainingACTIVE COMPARATOR: Two supervised 45-minute sessions of strength training \& Participants will be advised to comply with international recommendations of physical activity (150 min pf MVPA) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65
- history of breast or colon cancer
- no evidence of disease
- end of treatment in the last five years
- able to understand the questionnaire PERFORM
Key exclusion criteria (2 listed)
- mobility limitation
- treatment with beta-blockers
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 |
|---|---|---|
| Vigorous aerobic trainingSupervised vigorous aerobic training | Behavioural | A: Supervised combined training, B: Supervised strength training |
Primary outcome
Improvement in cancer related-fatigue
Time frame: 4 months
6 secondary outcomes
Changes in cardiorespiratory fitness
Time frame: 4 months
Changes in quality of life
Time frame: 4 months
adherence to the program
Time frame: 4 months
adherence to international recommendations
Time frame: 4 months
Changes in body composition
Time frame: 4 months
Employment status
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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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.
Itziar Pagola, PhD study director
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigorous aerobic training in people with Neoplasms and Fatigue, run by Puerta de Hierro University Hospital at 1 site in Spain.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 6 Apr 2018. 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 Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in cancer related-fatigue (time frame: 4 months). 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 6 Apr 2018.