NCT02883699

Brief Summary

The TOP Study is a two-stage study on individually tailored endurance and resistance training prescriptions for breast and prostate cancer patients after the end of primary therapy in order to optimize training effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

August 16, 2016

Last Update Submit

March 27, 2020

Conditions

Cancer

Keywords

Breast cancerProstate cancerExercise prescriptionHigh intensity interval trainingDaily undulating periodization trainingAerobic trainingResistance trainingPhysical fitnessExercise

Outcome Measures

Primary Outcomes (3)

  • Change in maximal oxygen uptake (VO2peak) (endurance training groups only)

    Change in maximal oxygen uptake (VO2peak) assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

    12 weeks

  • Change in one repetition maximum (1RM) of the knee extensors (resistance training groups only)

    Change in one repetition maximum (1RM) of the knee extensors in a machine based 1RM test

    12 weeks

  • Change in maximal isokinetic peak torque (MIPT) of the knee extensors (resistance training groups only)

    Change in maximal isokinetic peak torque (MIPT) of the knee extensors assessed in a stationary dynamometer test

    12 weeks

Secondary Outcomes (14)

  • Change in peak power output (PPO) (endurance training groups only)

    12 weeks

  • Change in blood lactate threshold (endurance training groups only)

    12 weeks

  • Change in ventilatory threshold (endurance training groups only)

    12 weeks

  • Change in maximum voluntary isometric contraction (MVIC) of the knee extensors (resistance training groups only)

    12 weeks

  • Change in total work (TW) of the knee extensors

    12 weeks

  • +9 more secondary outcomes

Study Arms (4)

Endurance Training Group 1

ACTIVE COMPARATOR

Standard endurance training

Behavioral: Standard endurance training

Endurance Training Group 2

EXPERIMENTAL

Polarized endurance training

Behavioral: Polarized endurance training

Resistance Training Group 1

ACTIVE COMPARATOR

Standard resistance training

Behavioral: Standard resistance training

Resistance Training Group 2

EXPERIMENTAL

Daily undulating periodization resistance training

Behavioral: Daily undulating periodization resistance training

Interventions

Standard endurance trainingBEHAVIORAL

Continuous vigorous training 2 x per week on a cycle ergometer

Endurance Training Group 1
Polarized endurance trainingBEHAVIORAL

Continuous moderate training 1 x per week and aerobic high intensity interval training (HIIT) 1 x per week on the cycle ergometer

Endurance Training Group 2
Standard resistance trainingBEHAVIORAL

Machine based hypertrophy training 2 x per week

Resistance Training Group 1
Daily undulating periodization resistance trainingBEHAVIORAL

Machine based daily undulating periodization resistance training 1 x per week

Resistance Training Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with early stage breast cancer (M0) or prostate cancer (M0 or M1 with PSA evidence of stable disease)
  • to 52 weeks after the end of primary therapy
  • ≥18 to 75 years of age
  • no regular endurance or resistance training (≥ one session per week) since diagnosis or within the last 6 months
  • sufficient German language skills
  • willing/ able to train at the provided exercise facilities twice per week and to take part in the scheduled testing
  • signed informed consent.

You may not qualify if:

  • diagnosed with additional other cancer
  • brain or bone metastases in M1 prostate cancer patients
  • heart failure \>NYHA III, unstable angina pectoris or severe arrhythmia
  • uncontrolled hypertension
  • reduced standing or walking ability
  • any other comorbidities that preclude participation in exercise testing or training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heidelberg University Clinic

Heidelberg, 69120, Germany

Location

Related Publications (1)

  • Pelzer F, Leisge K, Schluter K, Schneider J, Wiskemann J, Rosenberger F. Effects of exercise mode and intensity on patient-reported outcomes in cancer survivors: a four-arm intervention trial. Support Care Cancer. 2023 May 2;31(5):315. doi: 10.1007/s00520-023-07757-9.

    PMID: 37129687DERIVED

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsProstatic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Study Officials

  • Joachim Wiskemann, Dr.

    Heidelberg University Hospital, National Center for Tumor Diseases, Division of Medical Oncology, Working Group Exercise Oncology

    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
Principle Investigator

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 30, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2020

Study Completion

March 27, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)