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Recruiting NCT06745609

Prehabilitation Prior to Surgery for Kidney Tumors

No phase Interventional Renal Cancer Renal Cell Cancer Kidney Cancers Stage I Renal Cell Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prehabilitation.
Who it may be relevant to
Registry conditions: Renal Cancer, Renal Cell Cancer, Kidney Cancers, Stage I Renal Cell Cancer. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prehabilitation Prior to Surgery for Kidney Tumors: A Randomized Controlled Research Study (Pre-KiT)

Overview

The goal of this clinical trial is to examine if one month of general health optimization before surgery for kidney tumors can help participants recover more quickly from surgery. The optimization process is called prehabiliation, and will last one month. It consists of 1. A comprehensive health assessment 2. Assisted smoking cessation 3. A home exercise program. The investigators will compare an intervention group receiving one month of prehabilitation with a control group receiving the standard of care. Some of the main questions the investigators want to answer are * Are participants in the intervention group more satisfied with their quality of recovery after surgery? * Do participants in the intervention group maintain more of their physical abilites compared to the control group?

Interventions

  • Other Prehabilitation
    Pre-KiT prehabilitation consists of 1. A geriatric guided assessment with relevant interventions. The assessment will include cognitive evaluation, screening for depression, functional assessment, as well as evaluation of nutritional risk, assessment of past and current diseases, and a thorough review of the patient's medication list focusing on drug interactions. It will also include social history and standard laboratory results, 2. Physical activity. A four week home exercise program, adjust

Primary outcome measures

  • Change in quality of recovery from screening to outpatient follow-up 21 days after surgery [Time frame: From enrollment to outpatient follow-up at 21 days after surgery.]
Secondary outcome measures (10)
  • Change in Quality of Recovery at other times [Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.]
  • Change in the 30 second chair stand test [Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.]
  • Change in hand grip strength [Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.]
  • Compliance to the prehabilitation program [Time frame: From enrollment to the preoperative assessment]
  • Days alive and out of hospital 90 days [Time frame: From hospital discharge to follow-up 90 days after surgery.]
  • Change in Quality of Life [Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.]
  • Medical and surgical complications defined according to Clavien-Dindo at 30 and 90 days after surgery [Time frame: At 30 and 90 days after surgery.]
  • Health economic analysis [Time frame: From enrollment to 1 year follow-up]
  • Survival [Time frame: From surgery to 5 year follow-up.]
  • Change in muscle mass [Time frame: From enrollment to 1 year follow-up]

Eligibility criteria

Inclusion criteria

  • 65 years or older
  • cT1 kidney tumor, scheduled for either partial or radical nephrectomy.
  • Clinical Frailty Scale 3-6

Exclusion criteria

  • It is determined by an attending physician, or at a multi-disciplinary team-conference, that a 2-4 week postponement of surgery will not be beneficial for the participant.
  • Participant does not understand Danish og English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Denmark · 1 center
  • Department of Urology, Herlev and Gentofte Hospital — Herlev

Publications

  • Juul-Haslund M, Lund CM, Dolin TG, Schou-Jensen K, Ostergren PB, Vinther A, Thomsen FF, Fode M. Geriatric prehabilitation prior to surgery for kidney tumors: Study protocol for Pre-KiT - A randomized controlled trial. J Geriatr Oncol. 2026 Mar;17(2):102893. doi: 10.1016/j.jgo.2026.102893. Epub 2026 Jan 26. PMID 41592385

Identifiers

NCT: NCT06745609 · H-24066449

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗