CancerAPA2NCT02785341
Adaptated Physical Activity During Chemotherapy: Evaluation of the Psychological, Physiological and Biological Impact
A study testing questionnaires every 6 weeks (T0, T1, T2, T3 and T4), 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4) and leptin level with a blood test every 12 weeks (T0, T2 and T4) in people with Cancer, run by Institut Paoli-Calmettes.
Trial summary
Although treatments significantly increase the life expectancy of cancer patients, their quality of life is more or less reduced. The development of supportive care, such as physical activity, is one of the tools that should be promoted to maintain quality of life and reduce treatment side effects, including fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- questionnaires every 6 weeks (T0, T1, T2, T3 and T4), 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4) and leptin level with a blood test every 12 weeks (T0, T2 and T4)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or more,
- Performance status (WHO) ≤ 2
- Ability to participate in the IPCAPA program and medical certification of no contraindications to exercise
- Availability and willingness to participate in the IPCAPA study for the duration of the protocol
- Affiliated to a social security system
- Signed informed consent.
Who cannot join
- Pregnant or breastfeeding woman.
- Woman with childbirth ability without effective contraception.
- Patient in emergency situations, adult subject to a measure of legal protection (major trusteeship, guardianship or ward of court), or unable to consent.
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
- Inability to practice physical activity.
- Planned surgery within 24 weeks of inclusion.
About this study
Although treatments significantly increase the life expectancy of cancer patients, their quality of life is more or less reduced. The development of supportive care, such as physical activity, is one of the tools that should be promoted to maintain quality of life and reduce treatment side effects, including fatigue.
This study was developed to understand the different biopsychosocial effects of a physical activity program carried out with patients suffering from various types of cancers, and to facilitate and improve the implementation of this type of activity in health care facilities.
Read more
Study randomized, controlled, cross-over intervention evaluating a 12-week supervised and adapted physical activity program.
Participants were assigned to one of two groups: Group A which first follows a 12-week physical activity program, then undergoes usual care for 12 additional weeks, or Group B, which continues usual care for 12 weeks (control group) and then starts the physical activity program for 12 additional weeks. Quality of life (with questionnaires for 2 groups) , well-being, fatigue, physical capacity, leptin concentration, goal setting and level of physical activity are evaluated during this protocol.
By understanding the multidimensional effects of a physical activity program for various cancer types, depending on the time of proposing the program, by evaluating the correlations among all these variables, and by evaluating long-term effects, the IPCAPA study contributes to identifying the physical activity program which will be effective, viable and feasible for all patients undergoing chemotherapy, whatever the type of cancer.
Read the detailed description
Cancer is one of the leading causes of deaths in the world, with an estimated incidence of 14.1 million per year (2012) in the world, and 355,000 in France. Despite an increase in survival rates after cancer treatment, the psychological impact of the diagnosis and the aggressiveness of treatments such as chemotherapy tend to significantly decrease the quality of life of patients during and after cancer care.
Helping patients to support regular treatment is a crucial point in increasing compliance with treatment and thus increasing the cure rate, and many supportive care have been developed and implemented. Physical activity, now regarded as a non-drug therapy, provides many benefits, both in tertiary and secondary prevention during cancer treatment. Many studies have shown a decrease in mortality with physical activity during and after treatment, especially for breast, colon and prostate cancer. Regular physical activity during treatment increases patients' quality of life, for many types of cancer. The prevalence of fatigue during cancer is well described, as well as the need to effectively treat cancer related fatigue in order to enable patients to better withstand their treatment. Within the last decade, it has been pointed out that physical activity is one of the most efficient ways to combat cancer related fatigue.
From a psychological point of view, physical activity can decrease anxiety, depression and stress, and can also increase self-esteem, perceived control, and overall mental health.
Exercise physiologically increases physical capacity, strength, endurance and flexibility, and decreases physical symptoms such as pain and nausea. Biologically, physical activity often results in beneficial changes in the circulation level of adiponectin, leptin, insulin, and C-reactive protein, especially during breast, prostate and gastric cancer. Overall, physical activity during cancer treatment results in improvement in general quality of life, including mental, physical and social dimensions.
Although physical activity during cancer treatment is known to induce many benefits, depending on the cancer and the type of treatment, it is difficult to clearly investigate the effects of physical activity during cancer and how they interact or are sequential.
A better understanding of the close relationship between the psychological and physiological aspects might allow us to better understand the effects of physical activity during cancer. Exercise programs used during cancer treatment vary from one study to another in their duration, intensity and frequency. Furthermore, not all patients are included and not all types of cancers and treatment are considered.
Our study, named Institut Paoli Calmettes Adapted Physical Activity, was developed to understand the different biopsychosocial effects of a physical activity program carried out with patients suffering from various type of cancers, and to facilitate and improve the implementation of this type of activity in health care facilities.
- Conditions
- Cancer
- Being tested
- questionnaires every 6 weeks (T0, T1, T2, T3 and T4), 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4), leptin level with a blood test every 12 weeks (T0, T2 and T4)
- Keywords
- adapted physical activity
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires every 6 weeks (T0, T1, T2, T3 and T4)Other
Questionnaire MFI 20 Questionnaire life satisfaction Scale of measurement of the positive and negative affects Questionnaire QLQ-C30 (EORTC) Questionnaire on the personal goals
6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4)Other
leptin level with a blood test every 12 weeks (T0, T2 and T4)Other
blood sample
| Study group | Role | What they receive |
|---|---|---|
| Immediate adaptated physical activity (Group A) | Other | Group A began a physical activity program for 12 consecutive weeks from inclusion in the protocol, then underwent the usual care for 12 additional weeks.
Then to complete five evaluations with several questionnaires, and 6-minute walk test every 6 weeks (T0, T1, T2, T3 and T4) and leptin level with a blood test every 12 weeks (T0, T2 and T4). Receives: Other: questionnaires every 6 weeks (T0, T1, T2, T3 and T4); Other: 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4); Other: leptin level with a blood test every 12 weeks (T0, T2 and T4) |
| Without immediate adaptated physical activity (Group B) | Other | Group B followed the usual care for 12 weeks then started the physical activity program for 12 additional weeks.
Then to complete five evaluations with several questionnaires, and 6-minute walk test every 6 weeks (T0, T1, T2, T3 and T4) and leptin level with a blood test every 12 weeks (T0, T2 and T4). Receives: Other: questionnaires every 6 weeks (T0, T1, T2, T3 and T4); Other: 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4); Other: leptin level with a blood test every 12 weeks (T0, T2 and T4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of physical activity on fatigue during chemotherapy
Questionnaire MFI 20 (Multidimensional Fatigue Inventory)
Measured: From the inclusion in the protocol until week 24
Secondary outcomes (2)
Physiological evaluation
6-minute walk test
Measured: From the inclusion in the protocol until week 24
Biological evaluation
Leptin level with a blood test
Measured: Leptin concentration realized from inclusion (week 1) then week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAPPIELLO Maria Antonietta, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785341
- Sponsor's protocol ID
- APA2-IPC 2014-010
- Acronym
- APA2
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptated Physical Activity During Chemotherapy: Evaluation of the Psychological, Physiological and Biological Impact
- ClinicalTrials.gov ID
- NCT02785341
- Acronym / sponsor ID
- APA2 / APA2-IPC 2014-010
- Conditions
- Cancer
- Keywords
- adapted physical activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 May 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.
Although treatments significantly increase the life expectancy of cancer patients, their quality of life is more or less reduced. The development of supportive care, such as physical activity, is one of the tools that should be promoted to maintain quality of life and reduce treatment side effects, including fatigue.
This study was developed to understand the different biopsychosocial effects of a physical activity program carried out with patients suffering from various types of cancers, and to facilitate and improve the implementation of this type of activity in health care facilities.
Study randomized, controlled, cross-over intervention evaluating a 12-week supervised and adapted physical activity program.
Participants were assigned to one of two groups: Group A which first follows a 12-week physical activity program, then undergoes usual care for 12 additional weeks, or Group B, which continues usual care for 12 weeks (control group) and then starts the physical activity program for 12 additional weeks. Quality of life (with questionnaires for 2 groups) , well-being, fatigue, physical capacity, leptin concentration, goal setting and level of physical activity are evaluated during this protocol.
By understanding the multidimensional effects of a physical activity program for various cancer types, depending on the time of proposing the program, by evaluating the correlations among all these variables, and by evaluating long-term effects, the IPCAPA study contributes to identifying the physical activity program which will be effective, viable and feasible for all patients undergoing chemotherapy, whatever the type of cancer.
Detailed description
Cancer is one of the leading causes of deaths in the world, with an estimated incidence of 14.1 million per year (2012) in the world, and 355,000 in France. Despite an increase in survival rates after cancer treatment, the psychological impact of the diagnosis and the aggressiveness of treatments such as chemotherapy tend to significantly decrease the quality of life of patients during and after cancer care.
Helping patients to support regular treatment is a crucial point in increasing compliance with treatment and thus increasing the cure rate, and many supportive care have been developed and implemented. Physical activity, now regarded as a non-drug therapy, provides many benefits, both in tertiary and secondary prevention during cancer treatment. Many studies have shown a decrease in mortality with physical activity during and after treatment, especially for breast, colon and prostate cancer. Regular physical activity during treatment increases patients' quality of life, for many types of cancer. The prevalence of fatigue during cancer is well described, as well as the need to effectively treat cancer related fatigue in order to enable patients to better withstand their treatment. Within the last decade, it has been pointed out that physical activity is one of the most efficient ways to combat cancer related fatigue.
From a psychological point of view, physical activity can decrease anxiety, depression and stress, and can also increase self-esteem, perceived control, and overall mental health.
Exercise physiologically increases physical capacity, strength, endurance and flexibility, and decreases physical symptoms such as pain and nausea. Biologically, physical activity often results in beneficial changes in the circulation level of adiponectin, leptin, insulin, and C-reactive protein, especially during breast, prostate and gastric cancer. Overall, physical activity during cancer treatment results in improvement in general quality of life, including mental, physical and social dimensions.
Although physical activity during cancer treatment is known to induce many benefits, depending on the cancer and the type of treatment, it is difficult to clearly investigate the effects of physical activity during cancer and how they interact or are sequential.
A better understanding of the close relationship between the psychological and physiological aspects might allow us to better understand the effects of physical activity during cancer. Exercise programs used during cancer treatment vary from one study to another in their duration, intensity and frequency. Furthermore, not all patients are included and not all types of cancers and treatment are considered.
Our study, named Institut Paoli Calmettes Adapted Physical Activity, was developed to understand the different biopsychosocial effects of a physical activity program carried out with patients suffering from various type of cancers, and to facilitate and improve the implementation of this type of activity in health care facilities.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate adaptated physical activity (Group A) | Other | Other: questionnaires every 6 weeks (T0, T1, T2, T3 and T4), Other: 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4), Other: leptin level with a blood test every 12 weeks (T0, T2 and T4)Group A began a physical activity program for 12 consecutive weeks from inclusion in the protocol, then underwent the usual care for 12 additional weeks. Then to complete five evaluations with several questionnaires, and 6-minute walk test every 6 weeks (T0, T1, T2, T3 and T4) and leptin level with a blood test every 12 weeks (T0, T2 and T4). |
| Without immediate adaptated physical activity (Group B) | Other | Other: questionnaires every 6 weeks (T0, T1, T2, T3 and T4), Other: 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4), Other: leptin level with a blood test every 12 weeks (T0, T2 and T4)Group B followed the usual care for 12 weeks then started the physical activity program for 12 additional weeks. Then to complete five evaluations with several questionnaires, and 6-minute walk test every 6 weeks (T0, T1, T2, T3 and T4) and leptin level with a blood test every 12 weeks (T0, T2 and T4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 18 years or more,
- Performance status (WHO) ≤ 2
- Ability to participate in the IPCAPA program and medical certification of no contraindications to exercise
- Availability and willingness to participate in the IPCAPA study for the duration of the protocol
- Affiliated to a social security system
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman.
- Woman with childbirth ability without effective contraception.
- Patient in emergency situations, adult subject to a measure of legal protection (major trusteeship, guardianship or ward of court), or unable to consent.
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
- Inability to practice 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 |
|---|---|---|
| questionnaires every 6 weeks (T0, T1, T2, T3 and T4)Questionnaire MFI 20 Questionnaire life satisfaction Scale of measurement of the positive and negative affects Questionnaire QLQ-C30 (EORTC) Questionnaire on the personal goals | Other | Immediate adaptated physical activity (Group A), Without immediate adaptated physical activity (Group B) |
| 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4) | Other | Immediate adaptated physical activity (Group A), Without immediate adaptated physical activity (Group B) |
| leptin level with a blood test every 12 weeks (T0, T2 and T4)blood sample | Other | Immediate adaptated physical activity (Group A), Without immediate adaptated physical activity (Group B) |
Primary outcome
Impact of physical activity on fatigue during chemotherapy
Time frame: From the inclusion in the protocol until week 24
Questionnaire MFI 20 (Multidimensional Fatigue Inventory)
2 secondary outcomes
Physiological evaluation
Time frame: From the inclusion in the protocol until week 24
Biological evaluation
Time frame: Leptin concentration realized from inclusion (week 1) then week 12 and week 24
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Institut PAOLI-CALMETTESLink 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.
CAPPIELLO Maria Antonietta, MD principal investigator
Institut Paoli-Calmettes
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires every 6 weeks (T0, T1, T2, T3 and T4), 6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4) and leptin level with a blood test every 12 weeks (T0, T2 and T4) in people with Cancer, run by Institut Paoli-Calmettes.
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 6 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 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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: Insufficient recruitment). 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?
Impact of physical activity on fatigue during chemotherapy (time frame: From the inclusion in the protocol until week 24). 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 27 May 2016.