Clinical trial NCT05458154: Evaluation and Re-evaluation of Post-mastectomy Pain Syndrome by Breast Cancer EDGE Task Force Outcomes
Official title: Evaluation and Re-evaluation of Post-mastectomy Pain Syndrome by Breast Cancer EDGE Task Force Outcomes: Clinical Measures of Pain After Pain Management Protocol of Physiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-mastectomy Pain Syndrome
Keywords: breast cancer
mastectomy
pain
syndrome
Assessment
EDGE task force
physiotherapy
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2022-07-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the Breast Cancer EDGE Task Force is to provide physiotherapists with a comprehensive list of outcome measures that can be administered to a selected patient population, to assess post-mastectomy pain syndrome.

Detailed description: Female breast cancer incidence rates are slowly increasing by about 0.5% each year since the mid-2000s, attributed a minimum of partially to continued declines in fertility and increases in excess weight. the best number of deaths are from cancers of the lung, prostate, and colorectum in men and of the lung, breast, and colorectum in women. Incidence from 2014 through 2018 continued a slow increase for female breast cancer. For women, breast cancer, and lung cancer, account for 51% of all new diagnoses, with breast cancer alone accounting for nearly one-third.

According to the literature, the prevalence of chronic pain after breast cancer treatment varies from 25% to 60% in other countries.

Survival rates for breast cancer vary worldwide, but normally, rates have improved. In most countries, the five-year survival rate of early-stage breast cancers is 80-90 percent, falling to 24 percent for breast cancers diagnosed at a more advanced stage.

A systematic review evaluating risk factors for the event of persistent pain after surgery found that additionally to younger age, preoperative pain, intercostobrachial nerve damage during surgery, radiotherapy, also psychological morbidities are among the foremost frequently reported factors associated with chronic pain after breast cancer treatment.

Surgery could be a mainstay of primary breast cancer therapy. Alterations in surgical technique have reduced normal tissue injury, yet pain and functional compromise continue to occur following treatment.

Assa suggested that damage to the intercostobrachial nerve (ICBN) is also chargeable for the event of persistent pain arises from the lateral cutaneous branch of the second intercostal nerve and enters the axilla by perforating the second intercostal space and musculus serratus anterior within the midaxillary line. It then passes with considerable variability to the posteromedial border of the upper arm, leaving the ICBN in danger of harm during axillary surgery Post-mastectomy pain syndrome (PMPS) could be a chronic pain condition, typically neuropathic, which might occur following surgery on the breast.

Pain may be a common complication of breast cancer surgery. The event of chronic pain is one of the foremost frequently seen sequelae within the cancer survivor population.

Persistent pain after mastectomy was first reported during the 1970s, characterized as a dull, burning, and aching sensation within the anterior chest, arm, and axilla, exacerbated by movement of the shoulder girdle.

Although the pain related to breast cancer surgery includes different conditions (e.g., phantom-breast pain, pain around the mastectomy scar, or pain within the anterior chest wall). neuropathic pain due to intercostobrachial neuropathy-i.e. painful intercostobrachial neuropathy-is the foremost representative type of pain in breast cancer survivors The exact explanation for PMPS is unclear, but various etiological theories are postulated, including dissection of the intercostobrachial nerve, intraoperative damage to axillary nerve pathways, and pain caused by a neuroma, although evidence regarding the epidemiology of PMPS is growing, little is known about risk factors for the event of PMPS, or the long-term outcome of this chronic pain condition.

the International Association for the Study of Pain has defined chronic pain as that persisting beyond the traditional healing time of three months. Chronic pain was defined as PMPS supported by three criteria: character, location, and timing of pain. The identical criteria for PMPS were used at both time points to make sure comparability. Pain location was recorded as the same side of surgery, chest wall, axilla, or ipsilateral arm.

And "unpleasant sensory and emotional experience related to actual or potential tissue damage, or described in terms of such damage".

As the lesion recovers or the threat disappears, the pain sensation should normally decrease. However, when the pain remains persistent after the traditional tissue healing process, it can be considered chronic.

But, Neuropathic pain (NP), is defined by the International Association for the Study of Pain (IASP) as ''pain arising as a direct consequence of a lesion or disease affecting the somatosensory system will be a vital source of disability and distress in breast cancer patients already laid low with the psychological and medical stressors related to diagnosis and treatment and has been considered the foremost important contributor to chronic breast pain.

Neuropathic pain following breast surgery is often characterized by radiating pain, numbness, pins, and needles, burning, or stabbing. and is often related to paresthesia and hypersensitivity near the operative site.

The development of postoperative neuropathic pain (NPP) is related to many psychosocial and medical stressors, and for several, it represents a failure to return to normal life The current literature shows that chronic pain is related to nerve damage associated with the surgical technique, adjuvant therapy (such as chemotherapy, radiotherapy, and endocrine therapy), and younger age. However, these findings are equivocal because there's a body of literature that found no association between chemotherapy and chronic pain.

An important portion of breast cancer survivors needs to cope with complications and sequelae physical (lymphedema, neuropathy/pain, fatigue, menopausal symptoms, weight gain, etc.) and psychological nature (fear of recurrence, fear of death, change in body image, change in relationship, financial stress, etc.). These complications can arise during the treatment or can persist long after treatment cessation.

Eligibility criteria: Inclusion Criteria:

* Chronic pain \>= 3 months
* Pain is localized to the chest wall or axilla.
* The onset of pain is clearly after surgery or radiation therapy.
* Pain is persistent, not fluctuating.
* The patient is a minimum of 6 weeks post-radiation therapy.

Exclusion Criteria:

* Time since surgery was less than 6 months.
* The pain wasn't presented as an outcome, previous ipsilateral breast cancer, pregnancy, disease within the nervous system, psychiatric disease.
* Time since diagnosis was less than 1 year.

Primary outcomes:
measure: McGill Pain Questionnaire-Short Form
timeFrame: baseline
measure: Numeric Rating Scale
timeFrame: baseline
measure: Visual Analog Scale
timeFrame: baseline
Secondary outcomes:
measure: Brief Pain Inventory
timeFrame: baseline
measure: Brief Pain Inventory-Short Form
timeFrame: baseline
measure: McGill Pain Questionnaire
timeFrame: baseline
measure: Pain Disability Index
timeFrame: baseline
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Baheya Centre for Early Detection and Treatment of Breast Cancer institution
state: Haram
Study officials:
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