Cancer CachexiaAPACAVIRNCT06651125
EXPLORING the IMPACT of SUPERVISED PHYSICAL ACTIVITY INTERVENTION on CACHECTIC CANCER PATIENTS: a PRELIMINARY STUDY
A study testing Adapted Physical Activity in people with Cancer Cachexia, run by University of Rennes 2 at 1 site in France.
Trial summary
The goal of this project is to observe the benefits induced by physical activity during a supervised adapted physical activity program at SPORMED. Methodology: By agreeing to participate in this study, participation in a supervised adapted physical activity (APA) program at SPORMED and undergoing a series of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- Adapted Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 11 Apr 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years
- Diagnosis of cancer cachexia
- Able to participate in exercise program
- Registered with the French health insurance system
- Understanding and speaking French
Who cannot join
- Medical contraindications for exercise
- No report of weight changes in the last 6 months
- Disabilities to understand the study instructions
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to observe the benefits induced by physical activity during a supervised adapted physical activity program at SPORMED.
Methodology: By agreeing to participate in this study, participation in a supervised adapted physical activity (APA) program at SPORMED and undergoing a series of evaluations will be required.
Read more
At the start of the adapted physical activity program (T0), two APA sessions per week will be carried out for eight weeks. These group sessions, involving four participants, last 1 hour and are divided into 30 minutes of aerobic work on an ergometer followed by 30 minutes of muscle strengthening of the four limbs and core exercises, with or without small equipment. There is also the option to add a 45-minute balneotherapy session once a week, if desired and no contraindications are present. At the end of the eight weeks (T1), a follow-up phase begins, consisting of one APA session per week for another eight weeks. The session will be identical to the previously described sessions and can also be complemented by a balneotherapy session. The APA program will conclude after these 12 weeks (T2). A total of 24 indoor sessions will be offered, which can be supplemented by 12 balneotherapy sessions. Attendance at the sessions will be recorded.
Additionally, a series of evaluations will take place at T0, T1, and T2. These include physical and anthropometric assessments at SPORMED lasting approximately 30 minutes. They involve weight and body composition evaluation (2 minutes), height measurement (1 minute), waist and hip circumference measurements using a tape measure (2 minutes). Next, an upper limb strength test will be conducted, involving three maximal contractions during a handgrip test with 30-second rest intervals (2 minutes), followed by a lower limb strength test, which involves performing as many sit-to-stand repetitions from a chair with a backrest and without armrests as possible in 30 seconds (30 seconds). Then, a balance test, including bipodal and unipodal stance (30 seconds on both feet, followed by each foot individually), will be performed, and finally, a 6-minute walking test, during which the longest possible distance must be covered (without running) in 6 minutes (6 minutes, with the option to stop if necessary).
Additionally, four self-assessment questionnaires on quality of life, fatigue, physical activity level, and food consumption must be completed at home (about 20 to 30 minutes).
Read the detailed description
Patient volunteers were referred to Spormed sports medicine center by an oncologist and/or general practitioner. To be eligible for the study, participants had to be over 18 years old and have a diagnosis of cachexia-inducing cancer. Metastasis could be present or not. Participants could either be undergoing treatment or have completed treatment within the last year. They had to be able to participate in physical activity (PA). Additionally, registration with the French health insurance system and having French as the primary language were required. Those who could not report weight changes in the last 6 months, individuals with disabilities preventing them from understanding study instructions, and those with medical contraindications for PA were excluded from the study.
Participants were assigned to the "cachectic" group if classified in categories 3 or 4 of the Martin and colleagues classification. This classification is based on two criteria: percentage of weight loss in the past six months and body mass index. Participants classified as grades 0, 1, or 2 were included in the "non-cachectic" group. The "non-cachectic" group was matched to the "cachectic" group based on sex, age, and number of PA sessions completed. The aim was to verify whether the recognized effects of APA in non-cachectic individuals could be transferred to cachectic participants, with matching on the compliance variable to avoid an effect related to the amount of practice. Matching tumor type was not possible, as certain tumors are almost exclusively cachectizing.
Supervised Physical Activity Intervention:
The supervised PA intervention consisted of two sessions per week over a span of 12 weeks. Each session lasted one hour and was divided into 30 minutes of aerobic exercise using an ergometer (treadmill and/or bicycle), followed by 30 minutes of resistance exercises involving major muscle groups, with or without small equipment such as dumbbells, resistance bands, and balls. The exercise regimen was carried out at an intensity ranging from 50% to 70% of the heart rate reserve, with a rate of perceived exertion (RPE) set at 4 on a Borg scale of 0 to 10. A total of 24 sessions were planned. There was also the option to incorporate a 45-minute session of moderate-intensity water aerobics into the weekly routine.
- Conditions
- Cancer Cachexia
- Being tested
- Adapted Physical Activity
- Keywords
- Cancer Cachexia, Exercise, Adapted Physical Activity, Resistance training, Endurance training, Body composition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical ActivityOther
Patients in the Adapted Physical Activity arm realized a 12-weeks supervised exercise program. The supervised PA intervention consisted of two sessions per week. Each session lasted one hour and was divided into 30 minutes of aerobic exercise using an ergometer (treadmill and/or bicycle), followed by 30 minutes of resistance exercises involving major muscle groups, with or without small equipment such as dumbbells, resistance bands, and balls. The exercise regimen was carried out at an intensity ranging from 50% to 70% of the heart rate reserve, with a rate of perceived exertion (RPE) set at 4 on a Borg scale of 0 to 10. A total of 24 sessions were planned. There was also the option to incorporate a 45-minute session of moderate-intensity water aerobics into the weekly routine.
| Study group | Role | What they receive |
|---|---|---|
| Cachectic Cancer Patients | Experimental | Not described Receives: Other: Adapted Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition rate
Attrition rate was the number of patients who completed the baseline and follow-up assessments versus the number of patients who completed initial assessments and started the program
Measured: Through study completion, an average of 3 months
Compliance rate
Compliance rate was the number of sessions completed out of the number of sessions prescribed
Measured: Through study completion, an average of 3 months
Serious adverse events
Serious adverse events occurring during the exercise program
Measured: Through study completion, an average of 3 months
Secondary outcomes (10)
Nutritional status
Food intake was evaluated using the analog scale Simple Evaluation of Food Intake (SEFI®)
Measured: Through study completion, an average of 3 months
Body weight
Body weight (kg)
Measured: Through study completion, an average of 3 months
Fat mass
Fat mass was assessed using bioelectrical impedance analysis
Measured: Through study completion, an average of 3 months
Lean mass
Lean mass (kg) was assessed using bioelectrical impedance analysis (Tanita, DC-360).
Measured: Through study completion, an average of 3 months
Physical activity level
PA level was assessed using the International Physical Activity questionnaire Short-Form (IPAQ-SF). This 7 items questionnaire covers overall PA, broken down into intense, moderate and walking activities, and the level of sedentary lifestyle over the past seven days.
Measured: Through study completion, an average of 3 months
Functional aerobic capacity
Functional aerobic capacity was measured using the 6-minute walk test. Patients were instructed to walk back and forth along a 20-meter corridor to cover the greatest distance at constant speed. After 6 minutes, the distance walked was recorded in meters.
Measured: Through study completion, an average of 3 months
Lower limb strength
Proximal lower limb strength was evaluated using a 30-second (sec) chair sit-to-stand test. Patients were instructed to rise from a seated position to a standing position and return to seating, without assistance and without using their arms, as many times as possible within 30 sec. The number of complete stands within this period was recorded.
Measured: Through study completion, an average of 3 months
Grip strength
Grip strength was measured using a Hand Grip Digital Dynamometer (Takei 5401 Hand Grip Digital Dynamometer). The test was performed with patients in a sitting position, with both feet touching the ground, hand holding the dynamometer, elbow flexed at 90° and shoulder adducted. The participant were instructed to squeeze the handle with maximum force for 3 sec. The test was repeated three times, with 30 seconds of recovery time between each effort. The highest value of the three repetition was retained in kilograms (kg) for each hand.
Measured: Through study completion, an average of 3 months
Balance ability
Static balance ability was evaluated using the single-leg stance test. The time the patient-maintained balance on one leg with eyes open was recorded (maximum 30 sec).
Measured: Through study completion, an average of 3 months
Perceived Fatigue
Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI). The questionnaire comprises 20 statements in which the patient positions himself on a Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree").
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Nov 2020
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer CachexiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rennes 2
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peyrachon Romane, University of Rennes 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651125
- Sponsor's protocol ID
- APACAVIR
- Acronym
- APACAVIR
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richard C, Peyrachon R, Lievre A, Andre N, Chaory K, Rebillard A. Exercise as supportive care in advanced cancer-related weight loss: a feasibility study comparing patients with and without severe weight loss. Support Care Cancer. 2026 Apr 29;34(5):475. doi: 10.1007/s00520-026-10665-3.
PubMed 42053853
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPLORING the IMPACT of SUPERVISED PHYSICAL ACTIVITY INTERVENTION on CACHECTIC CANCER PATIENTS: a PRELIMINARY STUDY
- ClinicalTrials.gov ID
- NCT06651125
- Acronym / sponsor ID
- APACAVIR / APACAVIR
- Conditions
- Cancer Cachexia
- Keywords
- Cancer Cachexia, Exercise, Adapted Physical Activity, Resistance training, Endurance training, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Rennes 2University, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 21 Oct 2024 (actual)
- 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 goal of this project is to observe the benefits induced by physical activity during a supervised adapted physical activity program at SPORMED.
Methodology: By agreeing to participate in this study, participation in a supervised adapted physical activity (APA) program at SPORMED and undergoing a series of evaluations will be required.
At the start of the adapted physical activity program (T0), two APA sessions per week will be carried out for eight weeks. These group sessions, involving four participants, last 1 hour and are divided into 30 minutes of aerobic work on an ergometer followed by 30 minutes of muscle strengthening of the four limbs and core exercises, with or without small equipment. There is also the option to add a 45-minute balneotherapy session once a week, if desired and no contraindications are present. At the end of the eight weeks (T1), a follow-up phase begins, consisting of one APA session per week for another eight weeks. The session will be identical to the previously described sessions and can also be complemented by a balneotherapy session. The APA program will conclude after these 12 weeks (T2). A total of 24 indoor sessions will be offered, which can be supplemented by 12 balneotherapy sessions. Attendance at the sessions will be recorded.
Additionally, a series of evaluations will take place at T0, T1, and T2. These include physical and anthropometric assessments at SPORMED lasting approximately 30 minutes. They involve weight and body composition evaluation (2 minutes), height measurement (1 minute), waist and hip circumference measurements using a tape measure (2 minutes). Next, an upper limb strength test will be conducted, involving three maximal contractions during a handgrip test with 30-second rest intervals (2 minutes), followed by a lower limb strength test, which involves performing as many sit-to-stand repetitions from a chair with a backrest and without armrests as possible in 30 seconds (30 seconds). Then, a balance test, including bipodal and unipodal stance (30 seconds on both feet, followed by each foot individually), will be performed, and finally, a 6-minute walking test, during which the longest possible distance must be covered (without running) in 6 minutes (6 minutes, with the option to stop if necessary).
Additionally, four self-assessment questionnaires on quality of life, fatigue, physical activity level, and food consumption must be completed at home (about 20 to 30 minutes).
Detailed description
Patient volunteers were referred to Spormed sports medicine center by an oncologist and/or general practitioner. To be eligible for the study, participants had to be over 18 years old and have a diagnosis of cachexia-inducing cancer. Metastasis could be present or not. Participants could either be undergoing treatment or have completed treatment within the last year. They had to be able to participate in physical activity (PA). Additionally, registration with the French health insurance system and having French as the primary language were required. Those who could not report weight changes in the last 6 months, individuals with disabilities preventing them from understanding study instructions, and those with medical contraindications for PA were excluded from the study.
Participants were assigned to the "cachectic" group if classified in categories 3 or 4 of the Martin and colleagues classification. This classification is based on two criteria: percentage of weight loss in the past six months and body mass index. Participants classified as grades 0, 1, or 2 were included in the "non-cachectic" group. The "non-cachectic" group was matched to the "cachectic" group based on sex, age, and number of PA sessions completed. The aim was to verify whether the recognized effects of APA in non-cachectic individuals could be transferred to cachectic participants, with matching on the compliance variable to avoid an effect related to the amount of practice. Matching tumor type was not possible, as certain tumors are almost exclusively cachectizing.
Supervised Physical Activity Intervention:
The supervised PA intervention consisted of two sessions per week over a span of 12 weeks. Each session lasted one hour and was divided into 30 minutes of aerobic exercise using an ergometer (treadmill and/or bicycle), followed by 30 minutes of resistance exercises involving major muscle groups, with or without small equipment such as dumbbells, resistance bands, and balls. The exercise regimen was carried out at an intensity ranging from 50% to 70% of the heart rate reserve, with a rate of perceived exertion (RPE) set at 4 on a Borg scale of 0 to 10. A total of 24 sessions were planned. There was also the option to incorporate a 45-minute session of moderate-intensity water aerobics into the weekly routine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cachectic Cancer Patients | Experimental | Other: Adapted Physical Activity |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years
- Diagnosis of cancer cachexia
- Able to participate in exercise program
- Registered with the French health insurance system
- Understanding and speaking French
Key exclusion criteria (3 listed)
- Medical contraindications for exercise
- No report of weight changes in the last 6 months
- Disabilities to understand the study instructions
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 |
|---|---|---|
| Adapted Physical ActivityPatients in the Adapted Physical Activity arm realized a 12-weeks supervised exercise program. The supervised PA intervention consisted of two sessions per week. Each session lasted one hour and was divided into 30 minutes of aerobic exercise using an ergometer (treadmill and/or bicycle), followed by 30 minutes of resistance exercises involving major muscle groups, with or without small equipment such as dumbbells, resistance bands, and balls. The exercise regimen was carried out at an intensity ranging from 50% to 70% of the heart rate reserve, with a rate of perceived exertion (RPE) set at 4 on a Borg scale of 0 to 10. A total of 24 sessions were planned. There was also the option to incorporate a 45-minute session of moderate-intensity water aerobics into the weekly routine. | Other | Cachectic Cancer Patients |
Primary outcome
Attrition rate
Time frame: Through study completion, an average of 3 months
Attrition rate was the number of patients who completed the baseline and follow-up assessments versus the number of patients who completed initial assessments and started the program
Compliance rate
Time frame: Through study completion, an average of 3 months
Compliance rate was the number of sessions completed out of the number of sessions prescribed
Serious adverse events
Time frame: Through study completion, an average of 3 months
Serious adverse events occurring during the exercise program
10 secondary outcomes
Nutritional status
Time frame: Through study completion, an average of 3 months
Body weight
Time frame: Through study completion, an average of 3 months
Fat mass
Time frame: Through study completion, an average of 3 months
Lean mass
Time frame: Through study completion, an average of 3 months
Physical activity level
Time frame: Through study completion, an average of 3 months
Functional aerobic capacity
Time frame: Through study completion, an average of 3 months
Lower limb strength
Time frame: Through study completion, an average of 3 months
Grip strength
Time frame: Through study completion, an average of 3 months
Balance ability
Time frame: Through study completion, an average of 3 months
Perceived Fatigue
Time frame: Through study completion, an average of 3 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 21 Oct 2024.
- Derived from this study: PubMed 42053853Richard C, Peyrachon R, Lievre A, Andre N, Chaory K, Rebillard A. Exercise as supportive care in advanced cancer-related weight loss: a feasibility study comparing patients with and without severe weight loss. Support Care Cancer. 2026 Apr 29;34(5):475. doi: 10.1007/s00520-026-10665-3.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity in people with Cancer Cachexia, run by University of Rennes 2 at 1 site 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 3 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 21 Oct 2024. 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 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 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?
Attrition rate (time frame: Through study completion, an average of 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06651125, which also lists 1 linked publication.
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 21 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.