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Warm during surgery? new trial tests if temperature control boosts survival in older cancer patients

NCT ID NCT06256354

Disease control Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether carefully managing body temperature during major cancer surgery can lower the risk of postoperative delirium (sudden confusion) and improve long-term survival in patients aged 65 and older. About 4,000 participants will be randomly assigned to either routine temperature care or active warming. The goal is to see if a simple, low-cost change in the operating room can make a real difference for older adults recovering from cancer surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
targeted temperature management (keeping body temperature stable during surgery)
What this could lead to
If it works, this simple approach could reduce confusion after surgery and help older cancer patients live longer.
What could go wrong
This is a large trial, but it tests a small change in routine care—benefits may be modest or not statistically significant. The results may not apply to all surgeries or patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,992 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥65 years. 2. Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia. Exclusion Criteria: 1. Preoperative fever (tympanic temperature ≥38℃). 2. Known or suspected preoperative infection. 3. Previous history of schizophrenia, epilepsy, Parkinson disease, myasthenia gravis, or delirium. 4. Unable to communicate due to severe dementia, language barrier, or coma. 5. Critically ill (Left ventricular ejection fraction \<30%, Child-Pugh grades C, requirement of renal replacement therapy, American Society of Anesthesiologists physical status\>IV, or expected survival \<24 hours). 6. Scheduled surgery for breast cancer, intracranial tumors, or rare cancers. 7. Planned to undergo therapeutic hypothermia. 8. Body mass index \>30 kg/m2 (to facilitate thermal management). 9. Have participated in this study previously. 10. Any other conditions that are considered unsuitable for study participation.

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Conditions

The condition(s) this trial relates to.

cancer delirium Emergence Delirium

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer surgery Delirium Hypothermia Intraoperative hypothermia Long-term survivors Postoperative delirium Targeted temperature management

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aerospace Medical Center

    RECRUITING

    Beijing, Beijing Municipality, China

  • Beijing Chao-Yang Hospital, Capital Medical University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Beijing Chuiyangliu Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Beijing Coal Group General Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Beijing Electric Power Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Chengdu Seventh People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Deyang People's Hospital

    RECRUITING

    Deyang, Sichuan, China

  • Dongzhimen Hospital Beijing University of Chinese Medicine

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100007, China

  • First Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 163711, China

  • Guang'anmen Hospital China Academy of Chinese Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100055, China

  • Henan Provincial People's Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 463599, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jiangyin People's Hospital

    RECRUITING

    Jiangyin, Jiangsu, 214400, China

  • Jingzhou Central Hospital

    NOT_YET_RECRUITING

    Jingzhou, Hubei, China

  • Maanshan People's Hospital

    RECRUITING

    Ma’anshan, Anhui, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Peking University International Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Peking University Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, 518034, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610072, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 610042, China

  • The First Affiliated Hospital of Chengdu Medical College

    RECRUITING

    Chengdu, Sichuan, 610500, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Kangda College of Nanjing Medical University ( Lianyungang First People's Hospital)

    NOT_YET_RECRUITING

    Lianyungang, Jiangsu, China

  • The First Affiliated Hospital of Shandong First Medical University

    NOT_YET_RECRUITING

    Jinan, Shandong, 250013, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Hospital of Tsinghua University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • The People's Hospital of Chizhou

    NOT_YET_RECRUITING

    Chizhou, Anhui, 247099, China

  • The People's Hospital of Liaocheng

    RECRUITING

    Liaocheng, Shandong, 252000, China

  • The People's Hospital of Wuxi

    NOT_YET_RECRUITING

    Wuxi, Jiangsu, 214023, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230601, China

  • The Second Affiliated Hospital of Soochow University

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, China

  • The Second People's Hospital of Yibin (affiliated with West China Hospital of Sichuan University)

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • Xijing Hospital, Fourth Military Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100091, China

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Other studies related to the condition(s) this trial covers.