NeoplasmsLIONNCT06270628
Personalized Live-remote Exercise Training for Cancer Survivors
A study testing Exercise group in people with Neoplasms, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Background Many people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Feb 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, a subject must be:
- 18 years of age or older
- Diagnosed with any type of invasive cancer and have received systemic chemotherapy as part of their primary cancer treatment
- Within the timeframe of 12 weeks to 1 year after the completion of their primary cancer treatment with curative intent. Primary treatment, in this context, includes surgery, radiotherapy, and/or chemotherapy. For patients undergoing endocrine, targeted, or immunotherapy, their treatment must not be scheduled to be discontinued within the next 6 months.
- No evidence of distant metastatic disease (i.e., no diagnosis of metastatic disease in the regular clinical trajectory)
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
Show all 10Show fewer
- Presence of at least one of the following side-effects: fatigue (measured using EORTC QLQ-C30 fatigue symptom scale, score >39), perceived low physical functioning in daily life (measured using EORTC QLQ-C30 physical functioning scale, score <83), anxiety or depressive symptoms (measured using PHQ-ADS > 20), and/or CIPN (measured using 2 PRO-CTCAE items, score >0) for patients who received neurotoxic chemotherapy. Cut-off values are based on established thresholds.19-21
- Access to good quality and stable internet connection to access the live-remote training sessions.
- Able and willing to perform the exercise program and wear the activity tracker at least one week after T0 and before T2, T4, and T5 measurements and during training and online assessment sessions.
- Able to read, speak and understand the main country language.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Too physically active (i.e., >210 minutes/week of self-reported moderate-to-vigorous or leisure and sports activities; this threshold has also been used in other exercise RCTs, such as PREFERABLE-EFFECT22, and fits activity levels of all participating countries) or participation in an exercise program comparable to the LION exercise program.
- Following, or planned to follow, a structured psychological intervention during the intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic medication
- Participated in the intervention group of an exercise study during cancer treatment
- Inability to complete the testing or training sessions or any other contraindications for exercise as determined by the treating physician, including:
- Severe neurologic or cardiac impairment according to ACSM criteria
Show all 10Show fewer
- Uncontrolled severe respiratory insufficiency or dependence on oxygen suppletion in rest or during exercise
- Uncontrolled pain All these exclusion criteria are formulated to ensure safe participation in the LION exercise program
- Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the treating physician
- More than 1 week not able to attend training sessions during the LION intervention period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht
Anne May, Prof.
About this study
Official title: Demonstrating the (Cost-)Effectiveness of a Personalized Live-remote Exercise Intervention for Cancer Survivors Using a Super Umbrella Randomized Controlled Trial: the LION RCT
Background
Many people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.
Read more
Goal of the study:
The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.
Design of the study
In the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active.
The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.
Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.
Measurements
The main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.
Conclusion:
This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively.
Read the detailed description
SUMMARY
Rationale:
Many cancer patients suffer from long-term treatment-related side-effects like fatigue, low physical functioning, anxiety and/or depressive symptoms, and chemotherapy-induced peripheral neuropathy (CIPN). There is convincing evidence on the beneficial effects of general exercise interventions on these side-effects. However, studies to date generally fail to specifically screen for (long-term) side-effects at baseline and tailor the intervention to these specific side-effects, although larger exercise effects are observed in patients with a high symptom burden at baseline (e.g., with higher levels of fatigue). Larger effects of exercise are also observed for supervised exercise compared to unsupervised exercise. However, two of the most common barriers for attending and complying with supervised exercise are travel distance and time. An effective approach might be to provide live-remote supervision for exercise interventions. In this scenario, patients can receive guidance from a certified exercise specialist through a video-conferencing platform such as Zoom, while performing exercises within the comfort of their own homes. Currently, the effectiveness of live-remote exercise in cancer patients has not been established.
Objective:
The primary objective of the LION RCT is to assess the (cost-)effectiveness of a personalized, live-remote exercise intervention for cancer survivors on Health-Related Quality of Life (HRQOL) and the participants' main, self-reported side-effect. The four side-effects targeted in this study are: 1) fatigue, 2) perceived low physical functioning in daily life, 3) anxiety and/or depressive symptoms, and 4) CIPN.
Study design:
The LION RCT is a randomized controlled trial with two study arms: an exercise group (12 weeks) and a wait list control group. A super umbrella design will be used, allowing us to evaluate four exercise modalities (i.e., exercise modules based on participants' main side-effect) in a wide variety of cancer survivors.
Study population:
For this study, 350 adult cancer survivors treated with systemic chemotherapy (≥ 12 weeks to 1 year after completion of primary treatment of invasive cancer with curative intent) will be recruited independent of their primary cancer diagnosis. Participants will have reported at least one of the following side-effects: fatigue, low physical functioning in daily life, anxiety and/or depressive symptoms, CIPN. Additionally, participants need to be relatively physically inactive, i.e., perform ≤210 minutes/week of moderate-to-vigorous leisure and sports activities.
Intervention:
The intervention consists of three live-remote exercise sessions per week. Participants randomized to the exercise group receive the intervention after the baseline visit and the wait list control participants after the 12-week follow-up visit. A modular approach will be used to tailor the intervention to each participant's specific main side-effect. Each participant will receive the same base module (twice a week) to address HRQOL and in addition one out of four specific modules (once a week) addressing their individual main side-effect. In addition to the live-remote training, participants will be provided with the LION app and an activity tracker (Fitbit) at the start of the intervention to support exercise beyond the supervised program, during holidays and after the end of the intervention. In addition to exercise, the intervention also has an educational component including information about general effects of exercise for cancer patients and why exercise is important for specific side-effects. We consider the provision of such education as an integral part of adequate exercise programming.
After the intervention period of 12 weeks, we follow the patients until 36 weeks. In this follow-up period, also two sub studies take place:
- Sensor-based guidance sub study (only control patients from Cologne)
- Live-remote physical fitness and function testing (in all control patients; all sites)
- Conditions
- Neoplasms
- Being tested
- Exercise group
- Keywords
- cancer survivors, exercise, live remote, personalized exercise training
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupBehavioural
Live-remote exercise sessions, personalized to the patients main side-effect
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Participants will be offered three live-remote exercise training sessions per week. Each participant in the trial will be provided with the base module twice a week, which will involve a personalized training intensity. This module aims at targeting the participants' HRQOL, which is the first primary endpoint of the trial. Additionally, each participant will receive one out of four specific modules once a week to address their individual main side-effect (based on shared decision-making (SDM)) (second primary outcome). The intervention also includes an educational component about exercise and cancer. Receives: Behavioral: Exercise group |
| Wait list control group | No intervention | Regular care The control group will receive the same exercise program after the 12 weeks intervention period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life
Measured with the summary scale of the EORTC QLQ-C30; min 0- max 100 points; higher scores mean better quality of life
Measured: Week 0 - Week 12
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Side-effect 1: Fatigue measured with EORTC QLQ-FA12. According to a standardization procedure the symptom score of all patients will be combined into one symptom score..
Measured: Week 0 - Week 12
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Side-effect 2: Anxiety and depressive symptoms measured with Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). According to a standardization procedure the symptom score of all patients will be combined into one symptom score.
Measured: Week 0 - Week 12
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Side-effect 3: Physical functioning measured with EORTC QLQ-C30 physical function scale According to a standardization procedure the symptom score of all patients will be combined into one symptom score.
Measured: Week 0 - Week 12
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Side-effect 4: CPIN measured with EORTC QLQ-CPIN20. According to a standardization procedure the symptom score of all patients will be combined into one symptom score.
Measured: Week 0 - Week 12
Secondary outcomes (37)
Health-related quality of life
Domains of the EORTC QLQ-C30 (except summary score)
Measured: Week 0 - Week 36
Fatigue
Cancer-Related fatigue measured with the EORTC-FA12
Measured: Week 0 - Week 36
Anxiety and Depression
Anxiety and depressive symptoms measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Measured: Week 0 - Week 36
CIPN_1
Chemotherapy-induced peripheral neuropathy measured with EORTC QLQ-CIPN-20
Measured: Week 0 - Week 36
CIPN_2
2 items of the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Measured: Week 0 - Week 36
Sleep
Pittsburgh Sleep Quality Index (PSQI)
Measured: 0-36 weeks
Pain prevalence and type
EORTC QLQ-SURV100
Measured: Week 0 - Week 36
Cognitive problems
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Measured: Week 0 - Week 36
Work limitations
Work Limitations Questionnaire (WLQ)
Measured: Week 0 - Week 36
Body image
Body Image Scale (BIS)
Measured: Week 0 - Week 36
Fear of cancer recurrence
EORTC QLQ-surv100
Measured: 0-36 weeks
Habitual physical activity
Modified Godin-Shephard Leisure-Time Physical Activity Questionnaire
Measured: Week 0 - Week 36
Aerobic capacity on bike
Steep ramp test
Measured: Week 0 - Week 24
Aerobic capacity on step
Chester step test
Measured: Week 0 - Week 24
Handgrip strength
Handgrip test
Measured: Week 0 - Week 24
Upper body muscle strength
Chest press
Measured: Week 0 - Week 24
Lower body muscle strength
Leg press
Measured: 0-24 weeks
Sit to stand test
30 sec sit to stand test- function test
Measured: Week 0 - Week 24
Physical function
Time Up and Go (TUG) test
Measured: Week 0 - Week 24
Balance
Single leg stance test with open and closed eyes
Measured: Week 0 - Week 24
Physical activity
Measured with an activity tracker (Fitbit)
Measured: 0-36 weeks
Blood pressure
Measured twice with blood pressure device
Measured: 0-24 weeks
Resting heart rate
Measured with blood pressure device
Measured: Week 0 - Week 24
Weight
Weight. in KG
Measured: Week 0 - Week 24
Height
Height in cm
Measured: Week 0 - Week 24
Waist circumference
Waist circumference in cm
Measured: Week 0 - Week 24
Hip circumference
Hip circumference in cm
Measured: Week 0 - Week 24
Body composition
Fat mass and fat free mass with bio-impedance - three centers
Measured: Week 0 - Week 24
Inflammatory state
The specific inflammatory markers (e.g., cytokines, interleukins) will be decided at the time-point of analyses to be able to include factors according to up-to-date insights and use state-of the art platforms; we will for example use the Olink PEA platform (Oncology and Inflammation Array)
Measured: 0-12 weeks
Growth factors
The specific growth factors will be decided at the time-point of analyses to be able to include factors according to up-to-date insights and use state-of the art platforms ; we will for example use the Olink PEA platform (Oncology and Inflammation Array)
Measured: 0-12 weeks
CRP
Blood cell count
Measured: Week 0 - Week 12
Hemoglobin
Blood cell count
Measured: 0-12 weeks
Leucocyte counts
Blood cell count
Measured: 0-12 weeks
Quality-adjusted life years
EuroQol-5D-5L
Measured: Week 0 - Week 36
Health-care, patient and family costs
Modified Medical Consumption Questionnaire (iMCQ)
Measured: Week 0 - Week 36
Productivity losses
Modified Productivity Cost Questionnaire (iPCQ)
Measured: Week 0 - Week 36
Exercise-related (serious) adverse events
Via CASTOR app before and after each session; asked at and at the study visits.
Measured: Week 0 - Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start14 Feb 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT with two study arms: exercise group and wait list control group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center, German Sport University, Cologne, Cabrini Health (CAB), Malvern, Australia, Karolinska Institute (KI), Stockholm, Sweden, The Netherlands Cancer Institute, Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany, Fundacion Onkologikao (ONK), San Sebastian, Spain, Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal
- Responsible party
- Principal investigator, Dr. Anne May, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270628
- Sponsor's protocol ID
- NL85029.018.23
- Acronym
- LION
- Status last verified
- May 2026
- First submitted
- 15 Jan 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study analyses by the study team, the data will be anonymized and made available for sharing requests.
Publications
Hiensch AE, Muller J, Zopf EM, Schmidt ME, Monninkhof EM, Trevaskis M, Belloso J, Clauss D, Gunasekara N, Joaquim A, Viamonte S, Schumann M, Heinrich L, Kias A, Binyam D, van de Poll L, Buffart LM, Aaronson NK, van der Wall E, Campbell A, Wiskemann J, Rundqvist H, Alves AJ, Urruticoechea A, Bloch W, Stuiver MM, Wengstrom Y, Steindorf K, May AM. Effects of personalized live-remote exercise for individuals living beyond primary curative cancer treatment: study protocol for a multinational, super umbrella randomized controlled trial (LION-RCT). Trials. 2025 Nov 24;26(1):540. doi: 10.1186/s13063-025-09263-1.
PubMed 41287048
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrating the (Cost-)Effectiveness of a Personalized Live-remote Exercise Intervention for Cancer Survivors Using a Super Umbrella Randomized Controlled Trial: the LION RCT
- ClinicalTrials.gov ID
- NCT06270628
- Acronym / sponsor ID
- LION / NL85029.018.23
- Conditions
- Neoplasms
- Keywords
- cancer survivors, exercise, live remote, personalized exercise training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- German Cancer Research Center, German Sport University, Cologne, Cabrini Health (CAB), Malvern, Australia, Karolinska Institute (KI), Stockholm, Sweden, The Netherlands Cancer Institute, Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany, Fundacion Onkologikao (ONK), San Sebastian, Spain, Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Feb 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.
Background
Many people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.
Goal of the study:
The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.
Design of the study
In the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active.
The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.
Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.
Measurements
The main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.
Conclusion:
This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively.
Detailed description
SUMMARY
Rationale:
Many cancer patients suffer from long-term treatment-related side-effects like fatigue, low physical functioning, anxiety and/or depressive symptoms, and chemotherapy-induced peripheral neuropathy (CIPN). There is convincing evidence on the beneficial effects of general exercise interventions on these side-effects. However, studies to date generally fail to specifically screen for (long-term) side-effects at baseline and tailor the intervention to these specific side-effects, although larger exercise effects are observed in patients with a high symptom burden at baseline (e.g., with higher levels of fatigue). Larger effects of exercise are also observed for supervised exercise compared to unsupervised exercise. However, two of the most common barriers for attending and complying with supervised exercise are travel distance and time. An effective approach might be to provide live-remote supervision for exercise interventions. In this scenario, patients can receive guidance from a certified exercise specialist through a video-conferencing platform such as Zoom, while performing exercises within the comfort of their own homes. Currently, the effectiveness of live-remote exercise in cancer patients has not been established.
Objective:
The primary objective of the LION RCT is to assess the (cost-)effectiveness of a personalized, live-remote exercise intervention for cancer survivors on Health-Related Quality of Life (HRQOL) and the participants' main, self-reported side-effect. The four side-effects targeted in this study are: 1) fatigue, 2) perceived low physical functioning in daily life, 3) anxiety and/or depressive symptoms, and 4) CIPN.
Study design:
The LION RCT is a randomized controlled trial with two study arms: an exercise group (12 weeks) and a wait list control group. A super umbrella design will be used, allowing us to evaluate four exercise modalities (i.e., exercise modules based on participants' main side-effect) in a wide variety of cancer survivors.
Study population:
For this study, 350 adult cancer survivors treated with systemic chemotherapy (≥ 12 weeks to 1 year after completion of primary treatment of invasive cancer with curative intent) will be recruited independent of their primary cancer diagnosis. Participants will have reported at least one of the following side-effects: fatigue, low physical functioning in daily life, anxiety and/or depressive symptoms, CIPN. Additionally, participants need to be relatively physically inactive, i.e., perform ≤210 minutes/week of moderate-to-vigorous leisure and sports activities.
Intervention:
The intervention consists of three live-remote exercise sessions per week. Participants randomized to the exercise group receive the intervention after the baseline visit and the wait list control participants after the 12-week follow-up visit. A modular approach will be used to tailor the intervention to each participant's specific main side-effect. Each participant will receive the same base module (twice a week) to address HRQOL and in addition one out of four specific modules (once a week) addressing their individual main side-effect. In addition to the live-remote training, participants will be provided with the LION app and an activity tracker (Fitbit) at the start of the intervention to support exercise beyond the supervised program, during holidays and after the end of the intervention. In addition to exercise, the intervention also has an educational component including information about general effects of exercise for cancer patients and why exercise is important for specific side-effects. We consider the provision of such education as an integral part of adequate exercise programming.
After the intervention period of 12 weeks, we follow the patients until 36 weeks. In this follow-up period, also two sub studies take place:
- Sensor-based guidance sub study (only control patients from Cologne)
- Live-remote physical fitness and function testing (in all control patients; all sites)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with two study arms: exercise group and wait list control group
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise groupParticipants will be offered three live-remote exercise training sessions per week. Each participant in the trial will be provided with the base module twice a week, which will involve a personalized training intensity. This module aims at targeting the participants' HRQOL, which is the first primary endpoint of the trial. Additionally, each participant will receive one out of four specific modules once a week to address their individual main side-effect (based on shared decision-making (SDM)) (second primary outcome). The intervention also includes an educational component about exercise and cancer. |
| Wait list control group | No intervention | –Regular care The control group will receive the same exercise program after the 12 weeks intervention period |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age or older
- Diagnosed with any type of invasive cancer and have received systemic chemotherapy as part of their primary cancer treatment
- Within the timeframe of 12 weeks to 1 year after the completion of their primary cancer treatment with curative intent. Primary treatment, in this context, includes surgery, radiotherapy, and/or chemotherapy. For patients undergoing endocrine, targeted, or immunotherapy, their treatment must not be scheduled to be discontinued within the next 6 months.
- No evidence of distant metastatic disease (i.e., no diagnosis of metastatic disease in the regular clinical trajectory)
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
Key exclusion criteria (10 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Too physically active (i.e., >210 minutes/week of self-reported moderate-to-vigorous or leisure and sports activities; this threshold has also been used in other exercise RCTs, such as PREFERABLE-EFFECT22, and fits activity levels of all participating countries) or participation in an exercise program comparable to the LION exercise program.
- Following, or planned to follow, a structured psychological intervention during the intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic medication
- Participated in the intervention group of an exercise study during cancer treatment
- Inability to complete the testing or training sessions or any other contraindications for exercise as determined by the treating physician, including:
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 |
|---|---|---|
| Exercise groupLive-remote exercise sessions, personalized to the patients main side-effect | Behavioural | Exercise group |
Primary outcome
Health-Related Quality of Life
Time frame: Week 0 - Week 12
Measured with the summary scale of the EORTC QLQ-C30; min 0- max 100 points; higher scores mean better quality of life
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Time frame: Week 0 - Week 12
Side-effect 1: Fatigue measured with EORTC QLQ-FA12. According to a standardization procedure the symptom score of all patients will be combined into one symptom score..
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Time frame: Week 0 - Week 12
Side-effect 2: Anxiety and depressive symptoms measured with Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). According to a standardization procedure the symptom score of all patients will be combined into one symptom score.
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Time frame: Week 0 - Week 12
Side-effect 3: Physical functioning measured with EORTC QLQ-C30 physical function scale According to a standardization procedure the symptom score of all patients will be combined into one symptom score.
A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline
Time frame: Week 0 - Week 12
Side-effect 4: CPIN measured with EORTC QLQ-CPIN20. According to a standardization procedure the symptom score of all patients will be combined into one symptom score.
37 secondary outcomes
Health-related quality of life
Time frame: Week 0 - Week 36
Fatigue
Time frame: Week 0 - Week 36
Anxiety and Depression
Time frame: Week 0 - Week 36
CIPN_1
Time frame: Week 0 - Week 36
CIPN_2
Time frame: Week 0 - Week 36
Sleep
Time frame: 0-36 weeks
Pain prevalence and type
Time frame: Week 0 - Week 36
Cognitive problems
Time frame: Week 0 - Week 36
Work limitations
Time frame: Week 0 - Week 36
Body image
Time frame: Week 0 - Week 36
Fear of cancer recurrence
Time frame: 0-36 weeks
Habitual physical activity
Time frame: Week 0 - Week 36
Aerobic capacity on bike
Time frame: Week 0 - Week 24
Aerobic capacity on step
Time frame: Week 0 - Week 24
Handgrip strength
Time frame: Week 0 - Week 24
Upper body muscle strength
Time frame: Week 0 - Week 24
Lower body muscle strength
Time frame: 0-24 weeks
Sit to stand test
Time frame: Week 0 - Week 24
Physical function
Time frame: Week 0 - Week 24
Balance
Time frame: Week 0 - Week 24
Physical activity
Time frame: 0-36 weeks
Blood pressure
Time frame: 0-24 weeks
Resting heart rate
Time frame: Week 0 - Week 24
Weight
Time frame: Week 0 - Week 24
Height
Time frame: Week 0 - Week 24
Waist circumference
Time frame: Week 0 - Week 24
Hip circumference
Time frame: Week 0 - Week 24
Body composition
Time frame: Week 0 - Week 24
Inflammatory state
Time frame: 0-12 weeks
Growth factors
Time frame: 0-12 weeks
CRP
Time frame: Week 0 - Week 12
Hemoglobin
Time frame: 0-12 weeks
Leucocyte counts
Time frame: 0-12 weeks
Quality-adjusted life years
Time frame: Week 0 - Week 36
Health-care, patient and family costs
Time frame: Week 0 - Week 36
Productivity losses
Time frame: Week 0 - Week 36
Exercise-related (serious) adverse events
Time frame: Week 0 - Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 41287048Hiensch AE, Muller J, Zopf EM, Schmidt ME, Monninkhof EM, Trevaskis M, Belloso J, Clauss D, Gunasekara N, Joaquim A, Viamonte S, Schumann M, Heinrich L, Kias A, Binyam D, van de Poll L, Buffart LM, Aaronson NK, van der Wall E, Campbell A, Wiskemann J, Rundqvist H, Alves AJ, Urruticoechea A, Bloch W, Stuiver MM, Wengstrom Y, Steindorf K, May AM. Effects of personalized live-remote exercise for individuals living beyond primary curative cancer treatment: study protocol for a multinational, super umbrella randomized controlled trial (LION-RCT). Trials. 2025 Nov 24;26(1):540. doi: 10.1186/s13063-025-09263-1.
- study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After completion of the study analyses by the study team, the data will be anonymized and made available for sharing requests.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in people with Neoplasms, run by UMC Utrecht at 1 site in Netherlands.
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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evelyn Monninkhof, PhD (+3161118187, e.monninkhof@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (time frame: Week 0 - Week 12). The study lists 5 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 NCT06270628, 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 11 May 2026.