Clinical trial NCT05713786: Physical Exercise, Motor Activity and Post-mastectomy Pain Syndrome.
Official title: Effects of Physical Exercise and Motor Activity on Post-mastectomy Pain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Chronic pain
Post mastectomy pain syndrome
Motor activity
Pain markers
Lead sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women underwent unilateral or bilateral mastectomy due to resection of stage II and III breast cancer.

Brief summary: Pain is an unpleasant sensation common to all those who undergo surgery. Several studies indicate that 40-60% of patients experience the post-operative experience and can be caused by both internal and external stimuli. The most patients define the post-operative experience as a very painful condition that interferes with normal daily activities. Chronic post mastectomy pain is a condition characterized by pain in the anterior chest, armpit, and/or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery. It can become chronic in a broad spectrum of conditions. In fact, it is estimated that between 10 and 50% of elective interventions can generate persistent post-surgical pain.

Aim of this prospective observational study is to evaluate the effects of motor and/or sports activity on the intensity and interference of chronic pain in quality of life of women underwent mastectomy.

Detailed description: Acute post surgery pain is defined as a normal physiological response to an injurious stimulus.

Adequate monitoring associated with appropriate postoperative pain therapy significantly contribute to the improvement of perioperative morbidity, assessed in terms of lower incidence of postoperative complications. In addition, many patients undergo important changes in emotional and affective behavior: acute pain anxiety is often replaced by reactive depression and hypochondria combined with somatization and worsening of quality of life. The latter is an important factor in the context of tumor pathology. Since, while the goal of achieving 100% survival in women with breast cancer is still pursued, so too is improving the quality of life and restoring optimal levels of function of patients.The benefits of physical activity on the general population have been extensively studied. It has been shown that physical activity in the cancer patient allows the recovery of the previous functional capacities, strength and flexibility, improvement of the pain symptom and asthenia, as well as the reduction of alterations in the haematological picture such as neutropenia, anemia, thrombocytopenia.

Breast cancer is due to the uncontrolled multiplication of certain cells in the mammary gland which turn into malignant cells. The most frequent tumors arise from glandular cells (lobules) or from those that form the wall of the ducts.

Breast cancers can be invasive or non-invasive. The most invasive forms are usually ductal carcinoma, which affects the milk ducts beyond the duct wall and accounts for 70-80 percent of all forms of breast cancer, and lobular carcinoma that exceeds the wall of the lobule. Breast cancer is classified into 5 stages (0 to IV).

Chronic post mastectomy pain is a condition characterized by pain in the front of the chest, armpit, and / or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery (International Association for the Study of Pain.

In cancer patients, the level of pain intensity can be used in pain management as a subjective indicator to be quantitatively assessed together with what is defined as "interference of pain in activities of daily living". Interference is a key biomarker for establishing adequate pain therapy. Pain intensity and interference are both measured using questionnaires / scales such as the Numerical Rating Scale (NRS), the Brief Pain Inventory (BPI).

Finally, inflammatory responses and oxidative balance play key roles in the development and persistence of many pathological pain states. In light of the above, a prospective observational clinical study is proposed in order to evaluate the influence of motor activity on the intensity and interference of chronic pain in women who have undergone mastectomy surgery due to resection of stage breast cancer. II and III.

Study population: women underwent unilateral or bilateral mastectomy due to resection of stage II and III breast cancer not followed by breast reconstruction aged 18 years or older who have not received chemotherapy or radiation.

Pain assessment Pain assessment is a multidimensional process, which must take into account all the components of suffering, both physically, psychologically and socially. The assessment of pain and motor activity of each participant in the study will be carried out 3 and 6 months after surgery. Pain will be assessed by administration of the following questionnaires: Numerical Rating Scale, Brief Inventory Pain.

The IPAQ (International Physical Activity Questionnaire) questionnaire measures the type and amount of physical activity that is normally done. The questions refer to the activity carried out in the last 7 days. It will be administered at 3 and 6 months after surgery.The expected duration of the study can be considered to be approximately 12 months.

Interference is a key biomarker for establishing adequate pain therapy. Pain intensity and interference will be both measured using questionnaires/scales such as the numerical Rating scale (NRS), the Brief Pain Inventory (BPI) will be assessed 12 and 24 weeks after mastectomy by administration of the following questionnaires: Numerical Rating Scale, Brief Inventory Pain. Physical activity will be assessed by means of the IPAQ questionnaire (International Physical Activity.

At the same timepoints (12 and 24 weeks after surgery) biomarkers of pain, inflammation (C-reactive protein, Interleukin-6, interleukin-8, tumor necrosis factor-alpha) and oxidative stress (superoxide dismutase, catalase and malondyaldheide) will be measured together with routinary blood parameters.

Eligibility criteria: Inclusion Criteria:

* over the age of 18 with a diagnosis of previous Stages I-III breast cancer.

Exclusion Criteria:

* medical history of other types of cancer;
* disease related to the immune system (e.g. multiple sclerosis, HIV, lupus);
* recent symptoms of illness (cough, fever);
* waiting breast reconstruction;
* not chemotherapy or radiation during the first six months after surgery:

Primary outcomes:
measure: Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy.
timeFrame: Evaluation performed three and six months after surgery
measure: Effects of motor and/or sports activity on interference of chronic pain in women underwent mastectomy.
timeFrame: Evaluation performed three and six months after surgery
Secondary outcomes:
measure: Biomarkers of inflammation.
timeFrame: Evaluation performed three and six months after surgery
measure: Biomarkers of oxidative stress
timeFrame: Evaluation performed three and six months after surgery
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Gioacchino Calapai
Study officials:
affiliation: Azienda Ospedaliera Universitaria "G. Martino"
name: Gioacchino Calapai, MD
role: STUDY_DIRECTOR
References:
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