Physical Exercise, Motor Activity on Sleep Disorders in Post-Mastectomy Pain Syndrome

NCT06803563 | Completed

• 1 other identifier: BCMASD
• Study Type: observational
• Target: 180
• 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 sleep disturbance 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, sleep disorders 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 sleep disorders, caused by post-mastectomy chronic pain. of life of women underwent mastectomy

Conditions

Chronic Pain Syndrome

Keywords

Chronic pain; post mastectomy; sleep disorders; physical activity; haematological markers

Outcome Measures

Primary Outcomes (2)

• 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 sleep disorders in women underwent mastectomy suffering by chronic pain.

  Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the quality of sleep. The PSQI is a self-report inventory assessing sleep duration, latency, and overall sleep quality over 1 month time interval. Each item is weighted on a 0-3 interval scale. A score of 0 indicates no difficulty, while a score of 3, indicates severe difficulty. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores indicate an healthier sleep quality. A score ≤ 5 generally reflects a good sleep quality while a score \> 5 reflects a bad sleep qualityInsomnia Severity Index (ISI) The ISI is a self-rated instrument with seven items that assess insomnia's nature, severity, and impact, rated on a 5-point \[0 (no problem) - 4 (very severe problem)\]. Insomnia is graded as absent (score 0-7), mild (score 8-14), moderate (score15-21), and severe (score 22-28)

  Evaluation performed three and six months after surgery

Secondary Outcomes (2)

• Evaluation of biomarker associated to pain intensity and sleep disorders

  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 aging over 18 yearsunderwent 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

• Gioacchino Calapai: lead

Study Sites (1)

Gioacchino Calapai

Messina, Italy, 98125, Italy

Location

Related Publications (4)

• 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

• Magnan RE, Kwan BM, Bryan AD. Effects of current physical activity on affective response to exercise: physical and social-cognitive mechanisms. Psychol Health. 2013;28(4):418-33. doi: 10.1080/08870446.2012.733704. Epub 2012 Oct 23.

  PMID: 23088712 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

• Calapai M, Puzzo L, Bova G, Vecchio DA, Blandino R, Barbagallo A, Ammendolia I, Cardia L, Firenzuoli F, Calapai F, Curro M, Ficarra G, Esposito E, Trimarchi F, Di Mauro D, Calapai G, Mannucci C. Post-mastectomy pain syndrome and sleep disorders: effects of physical activity. Front Sports Act Living. 2025 Nov 20;7:1579635. doi: 10.3389/fspor.2025.1579635. eCollection 2025.

  PMID: 41357821 DERIVED

Related Links

• There are no website that provide information that is directly related to the study protocol

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Chronic Pain; Sleep Wake Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Mental Disorders; Behavior

Study Design

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

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: July 17, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 31, 2025

Record last verified: 2024-10

Locations

IT (1)