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NCT Number: NCT05588700

Impact of a 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.

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Key information

Conditions

Metastatic Testicular Cancer Endocrine Gland Neoplasms Endocrine System Diseases Fatigue Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Physical activity recommendations

Behavioral

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

Connected activity tracker

Behavioral

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) Intervention

Behavioral

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.

Primary outcomes

  1. cancer-related fatigue, considering both physical and cognitive fatigue scores at 3 years after the start of first-line chemotherapy

    Time frame: Year 3

    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.

Secondary outcomes

  1. other dimensions of fatigue

    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

    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).

  2. Health-related quality of life (EORTC QLQ-C30)

    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 (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.

  3. Health-related quality of life specific for testicular cancer (EORTC QLQ-TC26)

    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

    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.

  4. Proportion of patients who modify their cognition

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

    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.

  5. Proportion of patients who modify their anxiety and depression level

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

    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).

  6. Proportion of patients who change their anthropometry

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

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

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

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

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

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

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

    assessed by the hand-grip test (kg)

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

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

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

  10. Proportion of patients who change their physical activity (PA) and sedentary levels

    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

    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).

  11. Physical activity level

    Time frame: Every days during the first year

    number of days wearing the tracker

  12. Adherence to the physical activity tracker

    Time frame: Month 12

    number of days wearing the tracker

  13. Satisfaction with the intervention

    Time frame: Month 12

    self-administered questionnaire

  14. sleep quality and heart rate

    Time frame: continuously during the first year

    assessed by the connected watch

  15. compliance with PA sessions

    Time frame: Month 12

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

  16. Motivation

    Time frame: Inclusion, end of chemotherapy (Month 4), Month 12

    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.

  17. pre-intervention PA practice environment

    Time frame: Inclusion

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

  18. Number of participants with neuropathies and the neuropathies level

    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

    Neuropathies assessed by a visual analog scale. Participants will answer to a 0 (better outcome) to 10 (worst outcome) scale.

  19. Number of participants with pain and the pain level

    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

    Pain assessed by a visual analog scale. Participants will answer to a 0 (better outcome) to 10 (worst outcome) scale.

  20. TGCT relapse

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

    CT scan/tumor-marker increase

  21. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    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

    Occurrence of induced-treatment toxicity according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE)

  22. 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

    The occurence of second primary malignancy

  23. Sustainable return to work

    Time frame: Month 12, Year 2, Year 3

    number of consecutive working days without sick leave

  24. Immune and inflammatory biomarkers

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

    IL-1α/β, IL-6, IL-15, TNF-α, CRP

  25. liver function biomarkers

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

    ALT/AST, bilirubin

  26. gut microbiota composition and diversity

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

    measured using 16s rRNA Illumina sequencing

  27. french validation of EORTC QLQ-TC26

    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

    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

  28. a sociological study on patient engagement in physical activity

    Time frame: Inclusion, Month 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen Dupuis, PhD

CONTACT

[email protected]

0469856218 ext. +33

Olivia Pérol, PhD

CONTACT

[email protected]

0478782897 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • National Cancer Institute, France

Registry information

Official study 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

Acronym: STARTER

Important dates

Study start
2025
Primary completion
2031
Study completion
2038
First posted
Oct 20, 2022
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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