Effects of Chemotherapy Treatment on Metaboreflex, Mechanoreflex, and Baroreflex Function: PROTECT-08B Study

NCT07069790 | Recruiting

• 1 other identifier: 2025-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common cancer worldwide, with over 2.2 million new cases diagnosed in 2020. Treatments such as chemotherapy often lead to a reduced exercise capacity, mainly due to cardiovascular and neuromuscular dysfunctions. This decline appears to be primarily caused by increased central fatigue, while peripheral fatigue remains unchanged. This imbalance suggests a hyperactivation of type III-IV afferent nerve fibers, which are involved in the metaboreflex-a mechanism that significantly influences cardiovascular responses during exercise. Two non-invasive methods, post-exercise circulatory occlusion (PECO) and passive leg movement (PLM), will be used to assess this hyperactivity in patients. Additionally, baroreflex function-crucial for regulating blood pressure-will be evaluated using a direct method to determine its sensitivity and reactivity. By comparing patients with healthy controls under submaximal stimuli, this study aims to better understand chemotherapy-induced cardiovascular dysfunctions. Ultimately, the goal is to design personalized exercise programs to restore cardiovascular function and reduce treatment-related side effects.

Conditions

Breast Adenocarcinoma

Keywords

breast cancer; fatigue; muscle; heart

Outcome Measures

Primary Outcomes (1)

• Characterize the metaboreflex in breast cancer patients at the end of chemotherapy treatment

  Significant difference in mean arterial pressure, in response to a submaximal exercise, at rest and during exercise, between the two groups (patients and controls)

  3 weeks after end of chemotherapy

Secondary Outcomes (6)

• Characterize the baroreflex in breast cancer patients at the end of chemotherapy treatment.

  3 weeks after end of chemotherapy

• Characterize the mechanoreflex in breast cancer patients at the end of chemotherapy treatment.

  3 weeks after end of chemotherapy

• Compare heart rate reponses to submaximal exercise between the two groups

  3 weeks after end of chemotherapy

• Compare stroke volume responses to submaximal exercise between the two groups

  3 weeks after end of chemotherapy

• Compare cardiac output reponses to submaximal exercise between the two groups

  3 weeks after end of chemotherapy

Study Arms (1)

Test of neuromuscular fatigue and associated hemodynamic responses

EXPERIMENTAL

Other: Test of neuromuscular fatigue and associated hemodynamic responses

Interventions

Test of neuromuscular fatigue and associated hemodynamic responses OTHER

Baseline measurements of neuromuscular function and hemodynamic responses will be performed. Baroreflex sensitivity will be assessed using a neck collar applying positive and negative pressures to stimulate the carotid baroreceptors, thereby modulating baroreflex activity in a dose-dependent manner. Mechanoreflex activation will then be evaluated using the passive leg movement (PLM) technique. After the PLM, participants will perform four fatigue tasks, each followed by 2 minutes of post-exercise circulatory occlusion (PECO). Tasks involve isometric quadriceps contractions at 20% of maximal voluntary contraction (MVC) during 1 min (block 1), 2 min (blocks 2 and 3) and until failure (block4). Neuromuscular function will be assessed through MVC changes and quadriceps twitch responses. Mean arterial pressure (MAP) will be recorded continuously. Metaboreflex activity will be determined by plotting post-PECO changes in peripheral fatigue against the change in MAP during PECO phases.

Test of neuromuscular fatigue and associated hemodynamic responses

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient group :
• Stage I to III breast cancer
• Having completed (neo)adjuvant chemotherapy treatment less than three weeks ago
• Control group :
• \- healthy women (no history of cancer) of similar age, weight, and physical activity level

You may not qualify if:

• History of cancer
• Any known chronic pathology
• Protected minor or adult
• Psychiatric, musculoskeletal or neurological problems
• Implantation of a pacemaker
• Pregnant woman
• Presenting at least one contraindication to the use of transient blood flow occlusion

Sponsors & Collaborators

• Centre Paul Strauss: lead

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67100, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 17, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): October 2, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (1)