Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients
STARTER
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
1 other identifier
interventional
236
1 country
12
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedStudy Start
First participant enrolled
January 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 14, 2038
March 31, 2026
March 1, 2026
6 years
October 12, 2022
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Year 3
Secondary Outcomes (28)
other dimensions of fatigue
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)
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)
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
Inclusion, end of chemotherapy (Month 4), Month 12, Year 2, Year 3
Proportion of patients who modify their anxiety and depression level
Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
- +23 more secondary outcomes
Study Arms (2)
Control group
ACTIVE COMPARATORIntervention group
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Leon Berardlead
- National Cancer Institute, Francecollaborator
Study Sites (12)
Institut de Cancérologie de Lorraine
Angers, 49000, France
CHU Jean Minjoz
Besançon, 25030, France
Institut Bergonié
Bordeaux, 33000, France
Centre François Baclesse
Caen, 14076, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69008, France
Institut de Cancérologie de Lorraine
Nancy, 54519, France
Centre Antoine Lacassagne
Nice, 06189, France
AP-HP Tenon
Paris, 75020, France
Centre Eugène Marquis
Rennes, 35000, France
CHU Tours
Tours, 37000, France
Institut Gustave Roussy
Villejuif, 94800, France
Related Publications (1)
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.
PMID: 38225551DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aude Fléchon, MD
Centre Leon Berard
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2022
First Posted
October 20, 2022
Study Start
January 14, 2025
Primary Completion (Estimated)
January 14, 2031
Study Completion (Estimated)
January 14, 2038
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share