Physical Exercise, Motor Activity and Depression in Post-mastectomy Pain Syndrome

NCT06123559 | Completed

• 1 other identifier: BCMADA
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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. 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. Psychosocial factors such as anxiety and catastrophizing are being revealed as crucial contributors to individual differences in pain processing and outcomes. Some researchers have reported the associations between the development of persistent pain catastrophizing and depression or psychological distress and reduced physical activity. Taken together, these symptoms may lead to disability and worsened quality of life. Due to its benefits, the American Cancer Society recommends to begin as soon as possible from the diagnosis of cancer, physical activity. Aim of this prospective observational study is to evaluate the effects of motor and/or sports activity on the intensity of chronic pain and in symptoms of depression and anxiety, caused by post-mastectomy chronic pain. of life of women underwent mastectomy.

Conditions

Chronic Pain

Keywords

Chronic pain; post mastectomy; depression; anxiety; motor activity; haematological markers

Outcome Measures

Primary Outcomes (3)

• Effects of motor and/or sports activity on the intensity of chronic pain in women underwent mastectomy.

  Pain intensity self-measured using the Numerical Rating Scale (NRS). NRS is a 0-11 point-scale where the end points are the extremes of no pain (point 0) and worst pain as bad as it could be (point 10).

  Evaluation performed three and six months after surgery

• Effects of motor and/or sports activity on depression in women underwent mastectomy suffering by chronic pain.

  Depression will be evaluated with Beck's Depression Inventory (BDI) questionnaire. BDI consists of twenty-one questions about how the subject has been feeling in the last week. Each question has at least four possible answer choices; a value of 0 to 3 is assigned for each answer and then the total score determines the severity of depression as follow: 0-9: indicates normal or minimal depression; 10-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression.

  Evaluation performed three and six months after surgery

• Effects of motor and/or sports activity on anxiety in women underwent mastectomy suffering by chronic pain.

  Anxiety will be evaluated with Generalized Anxiety Disorders-7 (GAD-7) questionnaire. Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. A score of 0, 1, 2, and 3 is assigned to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21 described as follow: 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety.

  Evaluation performed three and six months after surgery

Secondary Outcomes (2)

• Evaluation of biomarker associated to pain intensity, depression and anxiety

  Evaluation performed three and six months after surgery]

• Evaluation of serum cortisol

  Evaluation performed three and six months after surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women underwent unilateral or bilateral mastectomy due to resection of stage II and III breast cancer.

You may not qualify if:

• 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);
• no antinflammatory or antidepressive or anxiolitic drugs assumption during the first six months after surgery
• waiting breast reconstruction;
• not chemotherapy or radiation during the first six months after surgery:

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Study Sites (1)

Gioacchino Calapai

Messina, 98125, Italy

Location

Related Publications (12)

• Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e.

  PMID: 17426506 BACKGROUND

• Calapai M, Esposito E, Puzzo L, Vecchio DA, Blandino R, Bova G, Quattrone D, Mannucci C, Ammendolia I, Mondello C, Gangemi S, Calapai G, Cardia L. Post-Mastectomy Pain: An Updated Overview on Risk Factors, Predictors, and Markers. Life (Basel). 2021 Sep 29;11(10):1026. doi: 10.3390/life11101026.

  PMID: 34685397 BACKGROUND

• Ambrose KR, Golightly YM. Physical exercise as non-pharmacological treatment of chronic pain: Why and when. Best Pract Res Clin Rheumatol. 2015 Feb;29(1):120-30. doi: 10.1016/j.berh.2015.04.022. Epub 2015 May 23.

  PMID: 26267006 BACKGROUND

• Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.

  PMID: 3461421 BACKGROUND

• Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.

  PMID: 23290256 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Hodes GE, Kana V, Menard C, Merad M, Russo SJ. Neuroimmune mechanisms of depression. Nat Neurosci. 2015 Oct;18(10):1386-93. doi: 10.1038/nn.4113. Epub 2015 Sep 25.

  PMID: 26404713 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.

  PMID: 13688369 BACKGROUND

• Alderman BL, Olson RL, Brush CJ, Shors TJ. MAP training: combining meditation and aerobic exercise reduces depression and rumination while enhancing synchronized brain activity. Transl Psychiatry. 2016 Feb 2;6(2):e726. doi: 10.1038/tp.2015.225.

  PMID: 26836414 BACKGROUND

• Archer T, Josefsson T, Lindwall M. Effects of physical exercise on depressive symptoms and biomarkers in depression. CNS Neurol Disord Drug Targets. 2014;13(10):1640-53. doi: 10.2174/1871527313666141130203245.

  PMID: 25470398 BACKGROUND

• Maes M, Abe Y, Sirichokchatchawan W, Suwimonteerabutr J, Sangkomkamhangd U, Almulla AF, Satthapisit S. The Cytokine, Chemokine, and Growth Factor Network of Prenatal Depression. Brain Sci. 2023 Apr 26;13(5):727. doi: 10.3390/brainsci13050727.

  PMID: 37239199 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Chronic Pain; Depression; Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 8, 2023
• Study Start: April 20, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-10

Locations

IT (1)