Renal CancerPre-KiTNCT06745609
Prehabilitation Prior to Surgery for Kidney Tumors
A study testing Prehabilitation in people with Renal Cancer and Renal Cell Cancer, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Renal Cancer, Renal Cell Cancer, Kidney Cancers
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Jan 2025to Mar 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years or older
- cT1 kidney tumor, scheduled for either partial or radical nephrectomy.
- Clinical Frailty Scale 3-6
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Urology, Herlev and Gentofte Hospital
Herlev, 2730
About this study
Official title: Prehabilitation Prior to Surgery for Kidney Tumors: A Randomized Controlled Research Study (Pre-KiT)
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
Read more
- A comprehensive health assessment
- Assisted smoking cessation
- 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?
- Conditions
- Renal Cancer, Renal Cell Cancer, Kidney Cancers, Stage I Renal Cell Cancer, Prehabilitation, Elderly (People Aged 65 or More)
- Being tested
- Prehabilitation
- Keywords
- Prehabilitation, Quality of life, Kidney tumor, Renal cell tumor, Renal cell cancer, Kidney cancer, Quality of recovery, Elderly
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Also called Geriatric assessment, Physical activity, Smoking cessation
Pre-KiT prehabilitation consists of
- 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,
- Physical activity. A four week home exercise program, adjusted to the participants physical abilities.
- Assisted smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in the control group are scheduled for surgery in compliance with the Danish cancer patient pathway guarantees (within 14 days). |
| Intervention with Pre-KiT prehabilitation | Experimental | Participants in the intervention group are scheduled for surgery after four weeks of Pre-KiT prehabilitation. The prehabilitation consists of a geriatric guided assessment with relevant targeted interventions, a home exercise program and assisted smoking cessation. Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of recovery from screening to outpatient follow-up 21 days after surgery
Quality of recovery is evaluated with the danish translation of the verified questionnaire Quality of Recovery-15. It is a 15-item patient questionnaire, where the score ranges from 0-150. A higher score indicates better patient-reported quality of recovery. QoR-15 will be assessed at enrollment, preoperatively, and 1, 21 and 90 days after surgery. Change in QoR-15 from enrollment to 21 days after surgery is the primary outcome measure. Change in QoR-15 at other assessment times will be assessed as secondary outcome measures.
Measured: From enrollment to outpatient follow-up at 21 days after surgery.
Secondary outcomes (10)
Change in Quality of Recovery at other times
Quality of recovery is measured by the danish translation of the verified questionnaire Quality of Recovery-15. It is a 15-item patient questionnaire, where the score ranges from 0-150. A higher score indicates better patient-reported quality of recovery. QoR-15 will be assessed at enrollment, preoperatively, and 1, 21 and 90 days after surgery.
Measured: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Change in the 30 second chair stand test
Physical ability is measured by the 30 second chair stand test. The test is performed at enrollment, preoperatively, 21 and 90 days after surgery.
Measured: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Change in hand grip strength
Physical ability is measured by hand grip strength. The test is performed with a hand-dynamometer at enrollment, preoperatively, 21 and 90 days after surgery.
Measured: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Compliance to the prehabilitation program
Compliance to the prehabilitation program is measured by brief phone interviews with the study participants in the intervention group two times a week during the intervention.
Measured: From enrollment to the preoperative assessment
Days alive and out of hospital 90 days
Days alive and out of hospital (DAOH) is the number of days not in hospital after surgery. DAOH will be calculated at 90 days after surgery.
Measured: From hospital discharge to follow-up 90 days after surgery.
Change in Quality of Life
Quality of life is evaluated with the danish translation of the validated questionnaire EQ-5D-5L. The questionnaire evalutes five health dimensions (mobility, self-care, usual acitivites, pain/discomfort, anxiety/depression) ranging from "no problems" to "unable/ extreme problems". Additionally, it includes a visual analog scale scoring from 0-100, reflecting the participants overall self-reported health state. A higher score indicates a better patient-reported quality of life. Quality of life will be assessed at enrollment, preoperatively, 21 and 90 days after surgery.
Measured: 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
Clavien-Dindo is a system to summarize and classify postoperative complications. Complications will be identified in participants records, and scored according to the Clavien-Dindo grades I-V, where V is the most severe. Registration of complications will be conducted at 30 and 90 days after surgery.
Measured: At 30 and 90 days after surgery.
Health economic analysis
Health-related expenses associated with standard treatment and PreKiT-based treatment will be analyzed and compared across the two study arms.
Measured: From enrollment to 1 year follow-up
Survival
Recurrence-free survival, Cause-specific survival and overall survival measured at 1 and 5 years after surgery.
Measured: From surgery to 5 year follow-up.
Change in muscle mass
Change in muscle mass, comparing measures on preoperative-CT and one year follow-up CT, including assessment of sarcopenia according to current European guidelines.
Measured: From enrollment to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start21 Jan 2025
- Primary completion1 Jun 2026
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Juul-Haslund, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745609
- Sponsor's protocol ID
- H-24066449
- Acronym
- Pre-KiT
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41592385