AzTrials
AzTrials

Metastatic Testicular CancerSTARTERNCT05588700

Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients

A study testing Physical activity recommendations, Connected activity tracker and Physical Activity (PA) Intervention in people with Metastatic Testicular Cancer, run by Centre Leon Berard at 12 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Testicular Cancer
What is being tested?
Physical activity recommendations, Connected activity tracker and Physical Activity (PA) Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
12 sitesFrance
Study dates
14 Jan 2025to 14 Jan 2038
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men ≥18 years
  • With a metastatic germ cell tumor histologically confirmed (seminoma and non-seminoma)
  • Who have already undergone an orchidectomy (since the 16th december, this criteria was deleted).
  • Having a first line of chemotherapy planned with BEP, EP or VIP
  • Having a smartphone (i.e. to connect the activity tracker)
  • PS < or = 2
Show all 11Show fewer
  • Whose ability to practice an adapted physical activity (APA) has been certified by a medical certificate issued by the referring oncologist or the investigating physician
  • Available and willing to participate in the study for the duration of the intervention and follow-up,
  • Able to understand, read and write French,
  • Affiliated with a social security scheme,
  • Having dated and signed an informed consent.

Who cannot join

  • Presence of symptomatic bone and/or brain metastases
  • Central nervous system involvement with neurological deficits preventing walking
  • History or coexistence of another primary cancer (apart from in situ cancer of any location and/or basal cell skin cancer and/or basal cell skin cancer and/or a cancer in complete remission for more than 3 years),
  • Contraindication to physical activity (e.g. uncontrolled hypertension, uncontrolled heart disease) uncontrolled heart disease),
  • Unable to be followed for medical, social, family, geographical or psychological reasons, during the entire study period,
  • Deprived of liberty by judicial or administrative decision, or adults protected by law,
  • Concurrent participation in another study in PA.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carmen Dupuis, PhD contact

0469856218 ext. +33

carmen.dupuis@lyon.unicancer.fr

Olivia Pérol, PhD contact

0478782897 ext. +33

olivia.perol@lyon.unicancer.fr

12 sites in 1 country

France12 sites, 12 recruiting

  • Institut de Cancérologie de Lorraine

    Angers, 49000

    Sophie ABADIE-LACOURTOISIE, MD, 0241352700, sophie.abadie-lacourtoisie@ico.unicancer.fr

    Sophie ABADIE-LACOURTOISIE, MD

    Not yet recruiting

  • CHU Jean Minjoz

    Besançon, 25030

    Elodie KLAJER, MD

    Guillaume MOUILLET, MD

    Not yet recruiting

  • Institut Bergonié

    Bordeaux, 33000

    Mathilde CABART, MD

    Mathilde CABART, MD

    Not yet recruiting

  • Centre François Baclesse

    Caen, 14076

    Florence JOLY, Pr, MD

    Florence JOLY, Pr, MD

    Not yet recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Guillaume CARBONNELLE, MD

    Guillaume CARBONNELLE, MD

    Not yet recruiting

  • Centre Leon Berard

    Lyon, 69008

    Aude FLECHON, MD, + 33 478 78 26 43, aude.flechon@lyon.unicancer.fr

    Aude FLECHON, MD

    Recruiting

  • Institut de Cancérologie de Lorraine

    Nancy, 54519

    Lionnel Goeffrois, MD

    Sophie MARTIN, MD

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Agnès DUCOULOMBIER, MD

    Agnès DUCOULOMBIER, MD

    Not yet recruiting

  • AP-HP Tenon

    Paris, 75020

    Jean-Pierre LOTZ, MD, 0156016058, jean-pierre.lotz@aphp.fr

    Jean-Pierre LOTZ, MD

    Not yet recruiting

  • Centre Eugène Marquis

    Rennes, 35000

    Christophe MASSARD, PhD, MD

    Christophe MASSARD, PhD, MD

    Not yet recruiting

  • CHU Tours

    Tours, 37000

    Mathilde CANCEL, MD, 0247477393, m.cancel@chu-tours.fr

    Mathilde CANCEL, MD

    Not yet recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Anna PATRIKIDOU, MD, 0142115947, Anna.PATRIKIDOU@gustaveroussy.fr

    Anna PATRIKIDOU, MD

    Recruiting

Other trials in France

About this study

Official title: A National, Multicenter, Phase III Randomized Controlled Trial to Assess the Impact of a One-year Supervised Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients

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.

Being tested
Physical activity recommendations, Connected activity tracker, Physical Activity (PA) Intervention
Keywords
fatigue, sequelae, gut microbiota composition
Medical subject headings
Testicular Neoplasms, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity recommendationsBehavioural

    At the baseline, all participants will receive the international recommendations in terms of physical activity for promoting health in the general population.

  • Connected activity trackerBehavioural

    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.

  • Physical Activity (PA) InterventionBehavioural

    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.

Study groups in NCT05588700
Study groupRoleWhat they receive
Control groupActive comparatorNot described
Receives: Behavioral: Physical activity recommendations; Behavioral: Connected activity tracker
Intervention groupExperimentalNot described
Receives: Behavioral: Physical activity recommendations; Behavioral: Connected activity tracker; Behavioral: Physical Activity (PA) Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Year 3

Secondary outcomes (28)

  1. 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).

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. 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.

    Measured: Inclusion, end of chemotherapy (Month 4), Month 12, Year 2, Year 3

  5. 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).

    Measured: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3

  6. Proportion of patients who change their anthropometry

    Weight (in kilograms), Height (in meters), Body Mass Index (in kg/m^2)

    Measured: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3

  7. Physical condition and muscular strength (6-minute walk test)

    assessed by the 6-minute walk test (distance traveled in meters in 6 minutes)

    Measured: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3

  8. Physical condition and muscular strength (hand-grip)

    assessed by the hand-grip test (kg)

    Measured: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3

  9. Physical condition and muscular strength (sit-to-stand test)

    assessed by the sit-to-stand test (number of repetitions)

    Measured: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3

  10. 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).

    Measured: 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

  11. Physical activity level

    number of days wearing the tracker

    Measured: Every days during the first year

  12. Adherence to the physical activity tracker

    number of days wearing the tracker

    Measured: Month 12

  13. Satisfaction with the intervention

    self-administered questionnaire

    Measured: Month 12

  14. sleep quality and heart rate

    assessed by the connected watch

    Measured: continuously during the first year

  15. compliance with PA sessions

    assessed by the number of sessions scheduled/performed during the different phases of the intervention

    Measured: Month 12

  16. 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.

    Measured: Inclusion, end of chemotherapy (Month 4), Month 12

  17. pre-intervention PA practice environment

    The association between the pre-intervention PA practice environment (type of activity, practice locations) and compliance with the intervention

    Measured: Inclusion

  18. 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.

    Measured: 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

  19. 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.

    Measured: 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

  20. TGCT relapse

    CT scan/tumor-marker increase

    Measured: Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10

  21. 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)

    Measured: 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

  22. Second primary malignancy

    The occurence of second primary malignancy

    Measured: 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

  23. Sustainable return to work

    number of consecutive working days without sick leave

    Measured: Month 12, Year 2, Year 3

  24. Immune and inflammatory biomarkers

    IL-1α/β, IL-6, IL-15, TNF-α, CRP

    Measured: Inclusion, end of chemotherapy (Month 4), Month 12, Year 3

  25. liver function biomarkers

    ALT/AST, bilirubin

    Measured: Inclusion, end of chemotherapy (Month 4), Month 12, Year 3

  26. gut microbiota composition and diversity

    measured using 16s rRNA Illumina sequencing

    Measured: Inclusion, end of chemotherapy (Month 4), Month 12, Year 3

  27. 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

    Measured: 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

  28. 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.

    Measured: Inclusion, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start14 Jan 2025
  3. Primary completion14 Jan 2031 (estimated)
  4. Study completion14 Jan 2038 (estimated)

Resources

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
Masking
None (open label)
Enrolment
236 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05588700
Sponsor's protocol ID
STARTER (ET 22-125)
Acronym
STARTER
Status last verified
Mar 2026
First submitted
12 Oct 2022
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Noh H, Anota A, Mongondry R, Meyrand R, Dupuis C, Schiffler C, Marijnen P, Rinaldi S, Lachuer J, Keski-Rahkonen P, Gunter MJ, Flechon A, Fervers B, Perol O. Impact of a one-year supervised physical activity program on long-term cancer-related fatigue and mediating effects of the gut microbiota in metastatic testicular cancer patients: protocol of the prospective multicentre, randomized controlled phase-III STARTER trial. BMC Cancer. 2024 Jan 15;24(1):84. doi: 10.1186/s12885-024-11824-7.

    PubMed 38225551

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity recommendations, Connected activity tracker and Physical Activity (PA) Intervention in people with Metastatic Testicular Cancer, run by Centre Leon Berard at 12 sites 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 11 inclusion and 7 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

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 Carmen Dupuis, PhD (0469856218 ext. +33, carmen.dupuis@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cancer-related fatigue, considering both physical and cognitive fatigue scores at 3 years after the start of first-line chemotherapy (time frame: Year 3). 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 NCT05588700, 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 31 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in