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Recruiting NCT07128030

Moderate-Intensity Exercise and Pain Sensitization in Breast Cancer Survivors: A Case-Based Study

No phase Interventional Exercise Training Breast Cancer Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Exercise Training, Breast Cancer, Pain Management. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The aim of this study was to evaluate the feasibility, safety, and acceptability of a supervised, combined moderate-intensity aerobic and resistance training program designed to reduce pain sensitization in BCS with persistent pain. Secondary objectives included assessing changes in pain intensity, somatosensory sensitivity, and temporal summation, while tertiary objectives focused on improvements in quality of life and functional capacity.

Interventions

  • Other Exercise
    The experimental group completed a five-week supervised program combining moderate-intensity aerobic and resistance training (150 min/week). Intensity was monitored using the Borg and OMNI-Res scales after familiarization sessions. Adherence was encouraged through reminders, motivational messages, and follow-ups. Unlike prior studies, this intervention focused specifically on neurophysiological pain modulation. Sessions included step-based aerobic exercises and resistance training with elastic b

Primary outcome measures

  • Adherence by Tolerance: number of incomplete sessions [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Tolerance: number of sessions at moderate intensity [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Tolerance: number of participants completing at moderate intensity [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Tolerance: number of progressions during the program [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Tolerance: final progression level reached [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: number of absences [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: percentage of sessions recovered after absence [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: number of dropouts [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: number of presence of positive sensations [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Adherence by Motivation: number of occurrence of adverse effects [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
Secondary outcome measures (11)
  • Brief Pain Inventory (BPI) [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Numerical Rating Scale (NRS) [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • SENSORIMOTOR CHARACTERISTICS: HANDGRIP STRENGTH [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Somatosensorial status (QST): MECHANICAL DETECTION THRESHOLD (MDT) [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Somatosensorial status (QST): MECHANICAL PAIN THRESHOLD (MPT) [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Somatosensorial status (QST): PAIN FACILITATION [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Somatosensorial status (QST): PRESSURE PAIN THRESHOLD (PPT) [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • Physical activity was assessed using the Global Physical Activity Questionnaire (GPAQ) [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23). [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]
  • CARDIOPULMONARY FITNESS [Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.]

Eligibility criteria

Inclusion criteria

  • Adult women diagnosed with stage I-III breast cancer
  • Completion of active treatment (surgery, chemotherapy, and/or radiotherapy) at least 6 months prior to enrollment
  • Presence of persistent pain or altered sensation in the upper quadrant of the affected limb related to oncologic treatment

Exclusion criteria

  • Bilateral breast cancer
  • Locoregional recurrence
  • Other malignancies
  • Pre-existing pain not related to cancer treatment
  • Neurological or cognitive disorders
  • Non-Spanish speakers
  • Contraindications to moderate-intensity physical activity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Spain · 1 center
  • Universidad Rey Juan Carlos — Madrid

Identifiers

NCT: NCT07128030 · EDCM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗