NCT03067922

Postmastectomy Pain Syndrome in an Indian Cancer Hospital

Completed Last updated 11 September 2019

What this trial tests

trial testing Non interventional study in Pain Syndrome in 120 participants. Completed in 6 September 2018.

Timeline

6 March 2017

Primary endpoint
6 March 2018

6 September 2018

Quick facts

Lead sponsor	Tata Memorial Centre
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	6 March 2017
Primary completion	6 March 2018
Estimated completion	6 September 2018
Sites	1 location across India

Drugs / interventions tested

• Non interventional study

Conditions studied

• Pain Syndrome — all drugs for Pain Syndrome →
• Mastectomy — all drugs for Mastectomy →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Tata Memorial Centre — full company profile →

Who can join

Adults 18 to 80, female only, with Pain Syndrome or Mastectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.