Testicular Cancer and Aerobic and Strength Training

NCT02577172 | Terminated

• 1 other identifier: REK - 2014/1169
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Neoplasms

Keywords

Testicular cancer; Physical Exercise; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• VO2peak (directly by modified Balke protocol on a treadmill)

  Differences in change in VO2peak from pre- to post-intervention between the exercise group and the control group.

  Pre-intervention (week 0) to post-intervention (week 10/13)

Secondary Outcomes (13)

• VO2peak (directly by modified Balke protocol on a treadmill)

  Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups

• Spirometry

  Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups

• One-repetition maximum muscle strength test (1RM)

  Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups

• Dual-energy X-ray absorptiometry (DXA)

  Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups

• Body mass index (BMI)

  Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups

Study Arms (2)

Exercise group

EXPERIMENTAL

Aerobic- and Strength Training program

Behavioral: Exercise group

Control group

ACTIVE COMPARATOR

One lifestyle counseling session

Behavioral: Control group

Interventions

Exercise group BEHAVIORAL

The intervention will be conducted during chemotherapy and tailored for each patient. The program will include 1) weight bearing aerobic exercises to maintain the oxygen transport and thereby reduce the decline in VO2max during chemotherapy and 2) strength training exercises to maintain muscle mass and muscle strength. The intervention will last for 9 or 12 weeks, depending on the number of BEP/EP cycles received. The program will consist of two-three one-hour exercise sessions per week, of which most supervised by a personal trainer. The intensity of each exercise sessions will varies from easy (warm-up: 60-70 % of peak heart rate) to moderate/high (between aerobic intervals 60-70% of peak heart rate and during aerobic intervals 85-95 %).

Exercise group

Control group BEHAVIORAL

The control group will receive one individual lifestyle counseling session during the first chemotherapy cycle and can perform all activities that they have planned to do during chemotherapy.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian School of Sport Sciences: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 32525564 DERIVED

MeSH Terms

Conditions

Testicular Neoplasms; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Lene Thorsen, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 16, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

NO (1)