Clinical trial NCT05588700: Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Testicular Cancer
Keywords: fatigue
sequelae
gut microbiota composition
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2022-10-20
Enrollment: 236
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Men ≥18 years
* With a metastatic germ cell tumor histologically confirmed (seminoma and non-seminoma)
* Who have already undergone an orchidectomy
* 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.

Primary outcomes:
measure: cancer-related fatigue, considering both physical and cognitive fatigue scores at 3 years after the start of first-line chemotherapy
timeFrame: Year 3
Secondary outcomes:
measure: other dimensions of fatigue
timeFrame: 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
measure: Health-related quality of life (EORTC QLQ-C30)
timeFrame: 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
measure: Health-related quality of life specific for testicular cancer (EORTC QLQ-TC26)
timeFrame: 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
measure: Proportion of patients who modify their cognition
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 12, Year 2, Year 3
measure: Proportion of patients who modify their anxiety and depression level
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
measure: Proportion of patients who change their anthropometry
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
measure: Physical condition and muscular strength (6-minute walk test)
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
measure: Physical condition and muscular strength (hand-grip)
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
measure: Physical condition and muscular strength (sit-to-stand test)
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3
measure: Proportion of patients who change their physical activity (PA) and sedentary levels
timeFrame: 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
measure: Physical activity level
timeFrame: Every days during the first year
measure: Adherence to the physical activity tracker
timeFrame: Month 12
measure: Satisfaction with the intervention
timeFrame: Month 12
measure: sleep quality and heart rate
timeFrame: continuously during the first year
measure: compliance with PA sessions
timeFrame: Month 12
measure: Motivation
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 12
measure: pre-intervention PA practice environment
timeFrame: Inclusion
measure: Number of participants with neuropathies and the neuropathies level
timeFrame: 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
measure: Number of participants with pain and the pain level
timeFrame: 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
measure: TGCT relapse
timeFrame: Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 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
measure: Second primary malignancy
timeFrame: 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
measure: Sustainable return to work
timeFrame: Month 12, Year 2, Year 3
measure: Immune and inflammatory biomarkers
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 12, Year 3
measure: liver function biomarkers
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 12, Year 3
measure: gut microbiota composition and diversity
timeFrame: Inclusion, end of chemotherapy (Month 4), Month 12, Year 3
measure: french validation of EORTC QLQ-TC26
timeFrame: 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
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François Baclesse
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Rennes
country: France
facility: Centre Eugène Marquis
Study officials:
affiliation: Centre Leon Berard
name: Aude Fléchon, MD
role: PRINCIPAL_INVESTIGATOR
References: