Exercise and Tumor Blood Flow in Lymphoma And Breast Cancer Patients (EXETUMOR 3)

NCT04990856 | Unknown

• 1 other identifier: T06/024/21
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Recent pre-clinical studies strongly suggest that due to dysfunctional vasculature and blunted sympathetic constriction in the tumor, tumor blood flow is increased even by 200% compared to resting values. However, to the best of our knowledge these blood flow aspects have never been addressed clinically. Therefore, this research aims at investigating tumor blood flow response to exercise in human cancer patients. To address this goal, in total twenty (20) newly diagnosed breast cancer and eight (8) lymphoma patients will be recruited for the present acute exercise and tumor perfusion clinical trial. To study the effect of acute physical exercise on tumor blood flow and its heterogeneity, 30 minute bicycle exercise will be used to exercise these patients. Tumor blood flow will be measured by positron emission tomography at rest before and after the exercise. If the hypothesis of increased blood flow in response to exercise will be detected, this project has the potential to increase the basic physiological and mechanistic understanding of tumor microvasculature function in humans, which is also clinically highly relevant and can have long-lasting influences in the field in the future. Thus, the results from the project can be a breakthrough for cancer treatment, its mechanistic arguments, and thus renewal of evidence-based medicine and patient care.

Conditions

Tumor

Keywords

tumor; PET; exercise; blood flow

Outcome Measures

Primary Outcomes (1)

• Blood flow

  Blood flow measured by PET imaging

  up to 12 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

Blood flow of the tumor experimented

Procedure: Exercise

Interventions

Exercise PROCEDURE

Tumor blood flow after acute exercise

Experimental arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a disease of newly diagnosed breast cancer, Hodgkin lymphoma, recurrent Hodgkin lymphoma and non-Hodgkin lymphoma with neck and thorax involvement.

You may not qualify if:

• abnormal fatigue, anemia, or physical dysfunction due to the disease

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre

Turku, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ilkka Heinonen

  Turku PET Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilkka Heinonen

CONTACT

+35823138145; ilkka.heinonen@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adj. prof

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: August 5, 2021
• Study Start: August 10, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: up to 12 months

Locations

FI (1)