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Post-mastectomy Pain SyndromeNCT05458154

Evaluation and Re-evaluation of Post-mastectomy Pain Syndrome by Breast Cancer EDGE Task Force Outcomes

A study testing questionnaires in people with Post-mastectomy Pain Syndrome, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Post-mastectomy Pain Syndrome
What is being tested?
questionnaires
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteEgypt
Study dates
3 Mar 2021to 4 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Baheya Centre for Early Detection and Treatment of Breast Cancer institution

    Giza, Haram, 12555

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
questionnaires
Keywords
breast cancer, mastectomy, pain, syndrome, Assessment, EDGE task force, physiotherapy
Medical subject headings
Breast Neoplasms, Pain, Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnairesOther

    Participants were recruited from the Baheya Centre for Early Detection and Treatment of Breast Cancer institution. Patients were eligible if they had a previously post-mastectomy pain syndrome (PMPS), and were presented with pain within the surgical area lasting more than 3 months. They were evaluated by questionnaires and methods of pain assessment then received their physiotherapy program specific for pain relief for six sessions, and so re-evaluation. All women gave informed written consent in Arabic and English forms.

Study groups in NCT05458154
Study groupRoleWhat they receive
Experimental groupExperimentalSeven of the 22 pain measures demonstrated satisfactory psychometric properties and clinical utility and are thereby recommended for clinical and research use in adults with a diagnosis of cancer. Participants received Physical therapy program is critical to preserve flexibility, strength, range of motion, and normal neuromuscular recruitment. Patients' efforts to cut back their pain through avoidance behaviors can severely undermine function if mobility, activity of daily living, performance, or vocational capacity are affected. Physical therapy may involve trials of analgesic modalities like desensitization techniques, transcutaneous electrical nerve stimulation (TENS), and topical cold. Modality trials are rapid, relatively harmless, and inexpensive with the additional benefit that patients can self-administer effective treatments The pain management protocol of physiotherapy of PMPS depends mainly on education regarding the subsequent points that are paramount.
Receives: Other: questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. McGill Pain Questionnaire-Short Form

    15-word descriptors that describe two dimensions of pain: sensory and affective.

    Measured: baseline

  2. Numeric Rating Scale

    the most ordinarily used one is the 11-item version, the rating of pain from (0 - 10).

    Measured: baseline

  3. Visual Analog Scale

    is a 10 cm-long horizontal line with the words "no pain" at one end and "pain as bad as it can be" at the other.

    Measured: baseline

Secondary outcomes (4)
  1. Brief Pain Inventory

    There's a complete of 32 items on the Brief Pain Inventory, it describes pain interferes with 7 domains of function within the last 24 hours:

    general activity, mood, walking ability, normal work, relations with people, sleep, and pleasure of life using a scale from 0 (no pain) to 10 (pain as bad as you can imagine).

    Measured: baseline

  2. Brief Pain Inventory-Short Form

    is a tool developed specifically to be used in individuals with cancer.

    Measured: baseline

  3. McGill Pain Questionnaire

    is a unique measure because it assesses pain using a multidimensional approach based on the gate control theoretical framework.

    contains three major classes of word descriptors: sensory, affective, and evaluative.

    Measured: baseline

  4. Pain Disability Index

    is a multidimensional tool designed to measure the degree to of chronic pain affects an individual's ability to perform a variety of activities.

    The PDI contains seven categories: family/home responsibility, recreation, social activity, occupation, sexual behavior, self-care, and life support activity.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2022
  2. Study start3 Mar 2021
  3. Primary completion3 Mar 2022
  4. Study completion4 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05458154
Sponsor's protocol ID
202103030005
Status last verified
Jul 2022
First submitted
29 Jun 2022
Last updated
14 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.

    PubMed 35020204
  • Kudel I, Edwards RR, Kozachik S, Block BM, Agarwal S, Heinberg LJ, Haythornthwaite J, Raja SN. Predictors and consequences of multiple persistent postmastectomy pains. J Pain Symptom Manage. 2007 Dec;34(6):619-27. doi: 10.1016/j.jpainsymman.2007.01.013. Epub 2007 Jul 16.

    PubMed 17629668
  • Poleshuck EL, Katz J, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for chronic pain following breast cancer surgery: a prospective study. J Pain. 2006 Sep;7(9):626-34. doi: 10.1016/j.jpain.2006.02.007.

    PubMed 16942948
  • Peuckmann V, Ekholm O, Rasmussen NK, Groenvold M, Christiansen P, Moller S, Eriksen J, Sjogren P. Chronic pain and other sequelae in long-term breast cancer survivors: nationwide survey in Denmark. Eur J Pain. 2009 May;13(5):478-85. doi: 10.1016/j.ejpain.2008.05.015. Epub 2008 Jul 16.

    PubMed 18635381
  • Arman M, Rehnsfeldt A, Lindholm L, Hamrin E. The face of suffering among women with breast cancer-being in a field of forces. Cancer Nurs. 2002 Apr;25(2):96-103. doi: 10.1097/00002820-200204000-00003.

    PubMed 11984096
  • Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

    PubMed 19903919
  • Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

    PubMed 25220842
  • Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.

    PubMed 21435953
  • Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782.

    PubMed 17457830
  • Assa J. The intercostobrachial nerve in radical mastectomy. J Surg Oncol. 1974;6(2):123-6. doi: 10.1002/jso.2930060206. No abstract available.

    PubMed 4822897
  • Cunnick GH, Upponi S, Wishart GC. Anatomical variants of the intercostobrachial nerve encountered during axillary dissection. Breast. 2001 Apr;10(2):160-2. doi: 10.1054/brst.2000.0226.

    PubMed 14965578
  • Loukas M, Hullett J, Louis RG Jr, Holdman S, Holdman D. The gross anatomy of the extrathoracic course of the intercostobrachial nerve. Clin Anat. 2006 Mar;19(2):106-11. doi: 10.1002/ca.20226.

    PubMed 16470542
  • Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.

    PubMed 8880841
  • Andersen KG, Duriaud HM, Kehlet H, Aasvang EK. The Relationship Between Sensory Loss and Persistent Pain 1 Year After Breast Cancer Surgery. J Pain. 2017 Sep;18(9):1129-1138. doi: 10.1016/j.jpain.2017.05.002. Epub 2017 May 11.

    PubMed 28502878
  • Glare PA, Davies PS, Finlay E, Gulati A, Lemanne D, Moryl N, Oeffinger KC, Paice JA, Stubblefield MD, Syrjala KL. Pain in cancer survivors. J Clin Oncol. 2014 Jun 1;32(16):1739-47. doi: 10.1200/JCO.2013.52.4629. Epub 2014 May 5.

    PubMed 24799477

Questions about this trial

What is this clinical trial studying?

A study testing questionnaires in people with Post-mastectomy Pain Syndrome, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

McGill Pain Questionnaire-Short Form (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05458154, which also lists 52 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.

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