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RecruitingLast updated: 25 November 2025

LION RCT: This study is evaluating whether personalised, live-remote exercise improves factors such as quality of life in people who have had cancer and completed primary treatmentDemonstrating the (Cost-)Effectiveness of a Personalized Live-remote Exercise Intervention for Cancer Survivors Using a Super Umbrella Randomized Controlled Trial: the LION RCT

Trial purpose

Medical clipboardSide effect and wellbeing

Tumor type

Multi-Cancer Multi-Cancer

Age

People18 - 100

Trial acronym

LION RCT

Clinical summary

Summary

Many cancer patients experience long-term side effects like fatigue, anxiety, and neuropathy. While exercise helps, most programs aren’t tailored to individual symptoms. Supervised exercise is more effective, but travel and time are barriers for people to participate. Live-remote supervision via video calls (Zoom) may be a promising solution, though its effectiveness in cancer patients is still unproven.

This study is assessing the general effectiveness and cost-effectiveness of a personalised live-remote exercise intervention on quality of life and treatment-related side effects. 

You may be eligible if you have cancer that has been treated with systemic chemotherapy and are ≥ 12 weeks to 1 year after completion of primary treatment of invasive cancer with curative intent; have reported one of the following side-effects: fatigue, low-physical functioning in daily life, anxiety and/or depressive symptoms, or chemotherapy-induced peripheral neuropathy; and be relatively physically inactive.

Eligible participants will be randomly allocated to one of two study arms: an exercise group (12 weeks) and a wait list control group.

The intervention consists of three live-remote exercise sessions per week. Participants in the exercise group will 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 health-related quality of life, and in addition one out of four specific modules (once a week) addressing their individual main seide-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 education component including information about general effects of exercise for cancer patients and why exercise is important for specific side-effects. The provision of such education is seen as an integral part of adequate exercise programming.

After the intervention period of 12-weeks, patients will be followed up until 36 weeks. In this follow-up period, also two sub studies take place:

  1. Sensor-based guidance sub study (only control patients from Cologne)
  2. Live-remote physical fitness and function testing (in all control patients; all sites)

Conditions

This trial is treating people with any type of invasive cancer who have received systemic chemotherapy as part of their primary cancer treatment

Eligibility

Inclusion

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
  • 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.

Exclusion

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
  • 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

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have had a certain type of treatment or surgical procedure.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

UMC Utrecht

Scientific 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

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