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ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Non interventional studyother
Likely dose
Not stated in record
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Search/NCT03067922
NCT03067922N/ACompleted

Post Mastectomy Pain Syndrome at an Indian Tertiary Cancer Centre: Incidence, Pain Severity, Impact on Daily Function and Quality of Life

Tata Memorial Centre·observational·Posted Mar 1, 2017·Updated Sep 11, 2019

In Brief

An observational study evaluating Non interventional study for Pain Syndrome and 2 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Breast cancer is the most common cancer in women in India and accounts for 27% of all cancers in women. Incidence rises in early thirties, peaks at 50-64 years. Approximately 48% are below 50 years of age. Most present when symptoms develop, so are 2B and beyond. Treatment depends on the stage of the disease. Surgical removal of the tumour is part of the treatment attempting a cure. Simple mastectomy involves removal of breast tissue without axillary lymph node dissection or removal of chest wall muscles. Radical mastectomy involves removal of the entire breast, skin, pectoralis major and minor muscles and ipsilateral axillary lymph nodes. Modified radical mastectomy involves removal of the breast and ipsilateral axillary lymph nodes. The pectoralis muscle is preserved. Breast conserving surgery involves removal of tumour with or without axillary dissection. The extent of surgery tells us about the nerve damage, local tissue handling. For example operating in upper and outer quadrant of breast and axilla increases nerve handling in that particular region. Local radiation also plays a role. Persistent pain after mastectomy was first reported in the 1970s by Wood and defined by International Association for Study of Pain (IASP) as pain in the anterior aspect of the thorax, axilla, and/or upper half of the arm beginning after mastectomy or quadrantectomy and persisting for more than three months after surgery and known as Postmastectomy pain Syndrome (PMPS). It is a common problem, with a 25- 60% incidence. The pain is described as burning or tenderness with paroxysms of lancinating, shock-like pain, and also described by some as dysesthesia (perception of non noxious stimuli as painful). Risk factors for PMPS include age, raised Body mass index (BMI), severity of postoperative pain, type of surgery, susceptibility to pain with a history of other pains such as headache and dysmenorrhoea. Axillary hematoma and postoperative radiotherapy have also been implicated in the development of PMPS. Tata Memorial Hospital, is a tertiary cancer institute in India. Around 4000 patients with suspected breast cancers register annually at the hospital and approximately 2800 breast cancer surgeries are performed yearly. Very few studies on PMPS in Indian population exist. We therefore plan to identify the incidence of PMPS in our patients and also the severity of pain along with its impact on daily function and quality of life

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 1, 2017
Enrollment StartMar 6, 2017
Primary CompletionMar 6, 2018
Study CompletionSep 6, 2018
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.3 years ago

Interventions

Non interventional studyother

Not applicable. No intervention will be done. it is an observational study assessing pain after mastectomy and the quality of life as assessed from validated questionnaires given to the patients at regular intervals