Non Metastatic Breast CancerNCT01563588
Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy
A study testing dietaty education, physical training, physiotherapy and SPA cares in people with Non Metastatic Breast Cancer, run by Centre Jean Perrin at 2 sites in France.
Trial summary
Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Non Metastatic Breast Cancer
- What is being tested?
- dietaty education, physical training, physiotherapy and SPA cares
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2008to Oct 2013
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer
- treatment including a chemotherapy
- in complete remission
- last treatment in the last 9 months before inclusion
- signed consent
Who cannot join
- metastatic disease
- relapse
- women enable to have physical activity
- heart disease or any pathology preventing physical activity
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Jean Perrin
Clermont-Ferrand, Puy de Dome, 63011
Pole Santé-République
Clermont-Ferrand, Puy de Dome, 63100
About this study
Official title: Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care
Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer.
The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.
- Conditions
- Non Metastatic Breast Cancer
- Being tested
- dietaty education, physical training, physiotherapy and SPA cares
- Keywords
- breast cancer, chemotherapy, first line treatment, treatments include a chemotherapy, last treatment not performed more than 9 months earlier
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietaty education, physical training, physiotherapy and SPA caresBehavioural
12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
| Study group | Role | What they receive |
|---|---|---|
| dietary and physical training | Experimental | 12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers Receives: Behavioral: dietaty education, physical training, physiotherapy and SPA cares |
| control | No intervention | dietary counseling by a dietetician in the anticancer hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (SF36)
Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months. The difference at one year was the main endpoint.
Measured: one year after inclusion
Secondary outcomes (4)
Anxiety/depression scores (HAD)
HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.
Measured: inclusion, 6, 12, 18, 24, 36 months
Weight and morphometric measures
Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups
Measured: inclusion, 6, 12, 18, 24, 36 months
Sleep quality
6 questions are asked: it rates the delay before sleep onset, the lenght of sleep, the number of awakening, the lenght of wake periods during the night, the concentration/alertness after sleep, and the fatigue in the morning.
Measured: inclusion, 6, 12, 18, 24, 36 months
economic figures
health related costs, health insurance costs, social costs
Measured: during 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startDec 2008
- Primary completionOct 2010
- Study completionOct 2013
Why it stopped: Enrollment lasted longer than expected and expected number of patients could not be matched in time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Metastatic Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Chollet, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563588
- Sponsor's protocol ID
- PACThe
- Other IDs
- 2008-A 01606 - 49
- Status last verified
- Dec 2015
- First submitted
- 22 Feb 2012
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care
- ClinicalTrials.gov ID
- NCT01563588
- Acronym / sponsor ID
- PACThe
- Conditions
- Non Metastatic Breast Cancer
- Keywords
- breast cancer, chemotherapy, first line treatment, treatments include a chemotherapy, last treatment not performed more than 9 months earlier
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment lasted longer than expected and expected number of patients could not be matched in time.
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Mar 2012 (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.
Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer.
The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary and physical training | Experimental | Behavioral: dietaty education, physical training, physiotherapy and SPA cares12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers |
| control | No intervention | –dietary counseling by a dietetician in the anticancer hospital |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- breast cancer
- treatment including a chemotherapy
- in complete remission
- last treatment in the last 9 months before inclusion
- signed consent
Key exclusion criteria (4 listed)
- metastatic disease
- relapse
- women enable to have physical activity
- heart disease or any pathology preventing physical activity
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 |
|---|---|---|
| dietaty education, physical training, physiotherapy and SPA cares12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers | Behavioural | dietary and physical training |
Primary outcome
Quality of life (SF36)
Time frame: one year after inclusion
Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months. The difference at one year was the main endpoint.
4 secondary outcomes
Anxiety/depression scores (HAD)
Time frame: inclusion, 6, 12, 18, 24, 36 months
Weight and morphometric measures
Time frame: inclusion, 6, 12, 18, 24, 36 months
Sleep quality
Time frame: inclusion, 6, 12, 18, 24, 36 months
economic figures
Time frame: during 2 years after inclusion
Results and safety
The study was stopped early (reason given: Enrollment lasted longer than expected and expected number of patients could not be matched in time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
- URL to Centre Jean Perrin main pageLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietaty education, physical training, physiotherapy and SPA cares in people with Non Metastatic Breast Cancer, run by Centre Jean Perrin at 2 sites in France.
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 4 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: stopped early, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: Enrollment lasted longer than expected and expected number of patients could not be matched in time.). Results are not available in the source record.
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?
Quality of life (SF36) (time frame: one year after inclusion). 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 28 Dec 2015.