NCT00869011

Brief Summary

In this randomized, controlled trial the investigators evaluate the effects of an exercise program lasting for 12 weeks on the physical performance, the cardiovascular function (24h blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients with renal cell carcinoma undergoing a therapy with Sunitinib.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

1.5 years

First QC Date

March 23, 2009

Last Update Submit

December 21, 2009

Conditions

Renal Cell Carcinoma

Keywords

Cancerrenal cell carcinomafatigueexercise

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    12 weeks

Secondary Outcomes (3)

  • VO2max

    12 weeks

  • Systolic and diastolic blood pressure (24 h)

    12 weeks

  • Depression score

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

Exercise

Other: Endurance exercise

2

NO INTERVENTION

No structured exercise program

Interventions

Endurance exerciseOTHER

Endurance exercise, 3 times weekly for 35-45 minutes, 12 weeks.

1

Eligibility Criteria

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

You may qualify if:

  • to 75 years
  • Understanding of written German
  • Treatment with Sunitinib
  • Ability to walk

You may not qualify if:

  • Cardiovascular, pulmonary or osteoarticular disease which can be aggravated by exercise
  • BMI \< 18 or \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Berlin, State of Berlin, 12200, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasmsFatigueMotor Activity

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Fernando C. Dimeo, MD

CONTACT

+493084452098fernando.dimeo@charite.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 25, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2011

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

DE(1)