An interventional study of Physical activity recommendations and Connected activity tracker in Metastatic Testicular Cancer, sponsored by Centre Leon Berard. Recruiting at 12 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Supportive care
Testicular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.
189 studies on the registry are indexed under Testicular Neoplasms; 53 are open to participants now.
This study's planned enrollment of 236 is above the median of 59 across 122 interventional studies indexed under Testicular Neoplasms.
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Exclusion Criteria:
Behavioral: Physical activity recommendations · Behavioral: Connected activity tracker
Behavioral: Physical activity recommendations · Behavioral: Connected activity tracker · Behavioral: Physical Activity (PA) Intervention
At the baseline, all participants will receive the international recommendations in terms of physical activity for promoting health in the general population.
At baseline, all participants will receive a connected activity tracker to wear 24 hours a day during one year. Patients will be asked to download an application, dedicated to the study so that the physical activity data (ie. number of steps per day) will be synchronized in the application.
The intervention will last 1 year and will have 2 phases. Phase 1: At each cycle of chemotherapy, patients will be proposed to perform 2-4 sessions per week. This program will be individual, supervised, performed at a moderate intensity. Between cycles, patients will be asked to perform 1-2 supervised collective live online physical activity sessions per week, proposed by a partner specialized in online PA. Phase 2: After chemotherapy, patients will be asked to perform 2-3 PA sessions per week at a moderate intensity. Patients will be offered different options of PA practice: in the supervised collective live online PA session (as already performed in the phase 1), and/or in a fitness center (this practice will take place in a "classic" environment with a 9-month free access for patients thanks to a partnership), and/or self-practice. In addition, patients will benefit from 4 individual motivational interviews, conducted by videoconference and/or by phone call with a professional.
cancer-related fatigue, considering both physical and cognitive fatigue scores at 3 years after the start of first-line chemotherapy
Multidimensional aspects of fatigue will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-FA12 cancer related fatigue module. EORTC QLQ-FA12 consists of 12 items to evaluated physical, cognitive and emotional domains of cancer-related fatigue. Participants will answer to a 4-points Likert scale ranging from "not at all" to "very much". All scores will be transformed to a 0 to 100 scale and higher scores will indicate greater degree of fatigue. The Primary Outcome Measure will be assessed with physical and cognitive items.
Time frame: Year 3
other dimensions of fatigue
Multidimensional aspects of fatigue will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-FA12 cancer related fatigue module. EORTC QLQ-FA12 consists of 12 items to evaluated physical, cognitive and emotional domains of cancer-related fatigue. Participants will answer to a 4-points Likert scale ranging from "not at all" to "very much". All scores will be transformed to a 0 to 100 scale and higher scores will indicate greater degree of fatigue. All of the secondary cancer related fatigue dimensions except the physical and cognitive items are evaluated (emotional fatigue, interference with daily life and social sequelae, assessed by the EORTC QLQ-FA12 questionnaire).
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
Health-related quality of life (EORTC QLQ-C30)
Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact).Participants will answer to a Likert scale ranging from "not at all" to "very much" and from "very bad" to "excellent" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden.
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
Health-related quality of life specific for testicular cancer (EORTC QLQ-TC26)
The module Quality of Life Questionnaire specific to Testicular Cancer (QLQ-TC26) comprises seven multi-item scales (treatment side effects, treatment satisfaction, future perspective, communication, sexual activity, functioning and enjoyment) and six single items (job and education problems, physical limitations, family problems, infertility, body image problems, testicular transplant satisfaction).Participants will answer to a Likert scale ranging from "not at all" to "very much". All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden.
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
Proportion of patients who modify their cognition
The cancer-related cognitive impairment will be measured by the Functional Assessment of Cancer Therapy-Cognition (FACT-Cog). The FACT-Cog is a validated self-administrated questionnaire in order to assess memory, attention, concentration, language, and thinking abilities. The questionnaire is composed of 37 items with four subscales: patients' perceived cognitive impairments, perceived cognitive abilities, deficits observed or commented on by others, and impact of cognitive changes on HRQoL. Participant will answer how often this situation occurred during the last 7 days on a Likert-type scale ranging from "never" to "several times a day". For both scales, higher scores indicated better perceived cognitive function.
Time frame: Inclusion, end of chemotherapy (Month 4), Month 12, Year 2, Year 3
Proportion of patients who modify their anxiety and depression level
Hospital Anxiety and Depression scale (HADS) is an instrument used to screen for anxiety and depressive disorders. It has 14 rated items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing thus obtaining two scores (maximum score for each score = 21).
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
Proportion of patients who change their anthropometry
Weight (in kilograms), Height (in meters), Body Mass Index (in kg/m\^2)
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
Physical condition and muscular strength (6-minute walk test)
assessed by the 6-minute walk test (distance traveled in meters in 6 minutes)
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
Physical condition and muscular strength (hand-grip)
assessed by the hand-grip test (kg)
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
Physical condition and muscular strength (sit-to-stand test)
assessed by the sit-to-stand test (number of repetitions)
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
Proportion of patients who change their physical activity (PA) and sedentary levels
PA and sedentary levels will be measured by National Observatory of Physical Activity and Sedentary Lifestyle - Physical Activity questionnaire (ONAPS-PAQ) This questionnaire assesses the level of physical activity and sedentary lifestyle during a typical week for the adult population. It is divided into three parts and 21 questions: activities at work, travel for utilitarian purposes and leisure or home activities. This questionnaire also assesses physical inactivity at all times of life (travel, work, leisure).
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
Physical activity level
number of days wearing the tracker
Time frame: Every days during the first year
Adherence to the physical activity tracker
number of days wearing the tracker
Time frame: Month 12
Satisfaction with the intervention
self-administered questionnaire
Time frame: Month 12
sleep quality and heart rate
assessed by the connected watch
Time frame: continuously during the first year
compliance with PA sessions
assessed by the number of sessions scheduled/performed during the different phases of the intervention
Time frame: Month 12
Motivation
This questionnaire can be used on a daily basis, for all populations, with the aim of better understanding the motivation of individuals to practice physical activities from a health perspective. The challenge is to provide professionals with an appropriate questionnaire that can assess patient motivation at the start and end of PA care. Participants will answer to a 7-points Likert scale ranging from "does not match at all" to "corresponds very strongly". This questionnaire assesses several items : intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, amotivation. The results for each patient should be compared with the results of the validation population.
Time frame: Inclusion, end of chemotherapy (Month 4), Month 12
pre-intervention PA practice environment
The association between the pre-intervention PA practice environment (type of activity, practice locations) and compliance with the intervention
Time frame: Inclusion
Number of participants with neuropathies and the neuropathies level
Neuropathies assessed by a visual analog scale. Participants will answer to a 0 (better outcome) to 10 (worst outcome) scale.
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
Number of participants with pain and the pain level
Pain assessed by a visual analog scale. Participants will answer to a 0 (better outcome) to 10 (worst outcome) scale.
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
TGCT relapse
CT scan/tumor-marker increase
Time frame: Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Occurrence of induced-treatment toxicity according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
Second primary malignancy
The occurence of second primary malignancy
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
Sustainable return to work
number of consecutive working days without sick leave
Time frame: Month 12, Year 2, Year 3
Immune and inflammatory biomarkers
IL-1α/β, IL-6, IL-15, TNF-α, CRP
Time frame: Inclusion, end of chemotherapy (Month 4), Month 12, Year 3
liver function biomarkers
ALT/AST, bilirubin
Time frame: Inclusion, end of chemotherapy (Month 4), Month 12, Year 3
gut microbiota composition and diversity
measured using 16s rRNA Illumina sequencing
Time frame: Inclusion, end of chemotherapy (Month 4), Month 12, Year 3
french validation of EORTC QLQ-TC26
To validate the psychometric properties of the French version of the EORTC QLQ-TC26 questionnaire assessing the health-related health-related quality of life in patients with testicular cancer
Time frame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
a sociological study on patient engagement in physical activity
The sociological approach will combine ethnographic research with semi-structured interviews with patients and healthcare professionals involved in the study. The ethnographic research will begin during the enrollment phase and will take place during interdisciplinary meetings, treatment sessions, physical activity initiation sessions, and end-of-session meetings. This study will be proposed only for 30 Patients of CLB and IGR, and they have to do two interviews.
Time frame: Inclusion, Month 12
Plan to share: No
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