Clinical trial NCT02577172: Testicular Cancer and Aerobic and Strength Training
Official title: Testicular Cancer and Aerobic and Strength Training - a Randomized Controlled National Phase II Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Testicular Neoplasms
Keywords: Testicular cancer
Physical Exercise
Chemotherapy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2015-10-16
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study examine the effects of an aerobic and strength training program on cardiorespiratory fitness in testicular cancer (TC) patients during chemotherapy. Half of the participants will receive the exercise program and the other half will receive one individual lifestyle counseling session. The investigators hypothesize that TC patients in the exercise group will have less reduction in cardiorespiratory fitness during chemotherapy treatment compared to patients in the control group.

Detailed description: Testicular cancer (TC) patients receiving chemotherapy often experience troublesome side-effects during and after treatment. Both aerobic and strength exercise have showed beneficial effects on side-effects during and after treatment in other cancer diagnosis. Knowledge of the effects of physical exercise during and after chemotherapy in TC patients is insufficient and studies are needed. The primary aim is to examine the effects of physical exercise on cardiorespiratory fitness in TC patients during chemotherapy. Secondary aims are to examine the effects of physical exercise on other secondary health outcomes during and three and twelve months after chemotherapy.

The present study is a randomized controlled trial comparing a tailored exercise program consisting of aerobic and strength training during chemotherapy to a control group receiving one individual lifestyle counseling session during the first chemotherapy cycle. The TC patients will be included and assessed before the first cycle of chemotherapy and further assigned to either a exercise group or a control group. The intervention will last for 9 or 12 weeks (depending on the number of bleomycin, etoposide, cisplatin (BEP)/etoposide, cisplatin (EP) cycles received) and it will consists of two-three one-hour sessions per week mostly supervised by a personal trainer. All variables will be assessed pre- and post-intervention, and at three and 12 months follow-up.

Eligibility criteria: Inclusion Criteria:

* testicular cancer with seminoma or non-seminoma
* stage II-IV
* referred to chemotherapy (3-4 BEP (bleomycin, etoposide and cisplatin)-cycles or 4 EP (etoposide and cisplatin) -cycles) with/without retroperitoneal lymph node dissection (RPLND)
* satisfactory Norwegian Language skills
* signed informed consent

Exclusion Criteria:

* severe brain and lung metastasis (reduced lung function)
* heart and lung diseases that contraindicate exercise testing and the supervised exercise program without adjusted actions according to American College of Sports Medicine (ACSM)'s guidelines)
* physical and mental conditions of a severity that complicates the ability for exercise testing and the supervised exercise program

Primary outcomes:
measure: VO2peak (directly by modified Balke protocol on a treadmill)
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13)
Secondary outcomes:
measure: VO2peak (directly by modified Balke protocol on a treadmill)
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Spirometry
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: One-repetition maximum muscle strength test (1RM)
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Dual-energy X-ray absorptiometry (DXA)
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Body mass index (BMI)
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Hip- and Waist circumferences
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Godin Leisure Time Exercise Questionnaire (GLTEQ)
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Sick leave and Work Ability Index (WAI)
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C-30
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Fatigue questionnaire
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Hospital and Anxiety and Depression Scale (HADS)
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Markers for inflammation, endothelia dysfunction, thrombosis and cardiovascular diseases and cisplatin
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups
measure: Safety and tolerability
timeFrame: Pre-intervention (week 0) to post-intervention (week 10/13)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Lene Thorsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thorsen L, Haugnes HS, Fossa SD, Brydoy M, Tandstad T, Wisloff T, Gjerset GM, Edvardsen E, Larsen KO, Sandset PM, Henriksson CE, Raastad T, Negaard HFS. Thromboembolic events after high-intensity training during cisplatin-based chemotherapy for testicular cancer: Case reports and review of the literature. Int J Cancer. 2020 Dec 1;147(11):3189-3198. doi: 10.1002/ijc.33151. Epub 2020 Jul 1.