NCT05737446

Brief Summary

Hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal surgery. This study aims to investigate whether similar changes also occur after breast cancer surgery. Inclusion: 60 women undergoing breast cancer surgery. Exclusion: Dementia or cognitive impairment that makes it impossible to participate in the study. Arterial blood gas and lung function are undertaken before surgery and the day after surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

February 10, 2023

Last Update Submit

March 28, 2023

Conditions

Breast CancerSurgery-ComplicationsHypoxia

Keywords

Breast cancer surgerypostoperative hypoxiaLung function

Outcome Measures

Primary Outcomes (1)

  • Oxygen partial pressure

    Change in oxygen partial pressure after surgery

    1 day

Secondary Outcomes (3)

  • Carbon dioxide partial pressure

    1 day

  • Vital capacity

    1 day

  • Forced expiratory volume in 1 second (FEV1)

    1 day

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with breast cancer scheduled for surgery.

You may qualify if:

  • Women scheduled for surgery because of breast cancer.

You may not qualify if:

  • Dementia or cognitive impairment that makes it impossible to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Surgery, University hospital

Umeå, Västerbotten County, 90185, Sweden

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsHypoxia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karl A Franklin, MD, Prof

    Dept Surgery, University hospital, Umea, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl A Franklin, MD, Prof

CONTACT

+46 70 6884745karl.franklin@umu.se

Magnus Hultin, MD, Ass Prof

CONTACT

+46 70 3505335magnus.hultin@umu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 21, 2023

Study Start

February 23, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

SE(1)