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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Testicular Cancer
- Sponsor
- Centre Leon Berard
- Enrollment
- 236
- Locations
- 8
- Primary Endpoint
- cancer-related fatigue, considering both physical and cognitive fatigue scores at 3 years after the start of first-line chemotherapy
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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,
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.
Outcomes
Primary Outcomes
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
- Satisfaction with the intervention(Month 12)
- Motivation(Inclusion, end of chemotherapy (Month 4), Month 12)
- Immune and inflammatory biomarkers(Inclusion, end of chemotherapy (Month 4), Month 12, 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)
- Proportion of patients who change their anthropometry(Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3)
- Physical condition and muscular strength (6-minute walk test)(Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3)
- Physical condition and muscular strength (hand-grip)(Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3)
- Second primary malignancy(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(Month 12, Year 2, Year 3)
- gut microbiota composition and diversity(Inclusion, end of chemotherapy (Month 4), Month 12, Year 3)
- french validation of 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)
- 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 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)
- compliance with PA sessions(Month 12)
- Number of participants with pain and the pain level(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 treatment-related adverse events as assessed by CTCAE v5.0(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 change their physical activity (PA) and sedentary levels(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(Every days during the first year)
- Adherence to the physical activity tracker(Month 12)
- sleep quality and heart rate(continuously during the first year)
- liver function biomarkers(Inclusion, end of chemotherapy (Month 4), Month 12, Year 3)
- 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)
- Physical condition and muscular strength (sit-to-stand test)(Inclusion, end of chemotherapy (Month 4), Month 6, Month 12, Year 2, Year 3)
- pre-intervention PA practice environment(Inclusion)
- Number of participants with neuropathies and the neuropathies level(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(Month 12, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10)