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Postmastectomy Pain Syndrome in an Indian Cancer Hospital

This study is currently recruiting participants.
Verified April 2017 by Dr Aparna Chatterjee, Tata Memorial Centre
Sponsor:
ClinicalTrials.gov Identifier:
NCT03067922
First Posted: March 1, 2017
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Aparna Chatterjee, Tata Memorial Centre
  Purpose

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


Condition Intervention
Pain Syndrome Mastectomy Quality of Life Other: Non interventional study

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Post Mastectomy Pain Syndrome at an Indian Tertiary Cancer Centre: Incidence, Pain Severity, Impact on Daily Function and Quality of Life

Resource links provided by NLM:


Further study details as provided by Dr Aparna Chatterjee, Tata Memorial Centre:

Primary Outcome Measures:
  • Incidence of Post mastectomy pain syndrome (PMPS) [ Time Frame: 6 months after surgery ]
    presence of pain around the mastectomy site and ipsilateral arm after the mastectomy


Secondary Outcome Measures:
  • pain severity [ Time Frame: At 1 month after surgery ]
    How severe the pain is after mastectomy from the Pain intensity obtained from the Brief Pain inventory questionnaire

  • pain severity [ Time Frame: At 4 months after surgery ]
    How severe the pain is after mastectomy from the pain intensity obtained from the Brief Pain inventory questionnaire

  • pain severity [ Time Frame: At 6 months after surgery ]
    How severe the pain is after mastectomy from the pain intensity obtained from the Brief Pain inventory questionnaire

  • Impact on daily function [ Time Frame: At 1 month after surgery ]
    How the pain after mastectomy per se affects day to day functioning of the patient and how the quality of her life is affected. The impact of pain on daily life will be identified from the Brief Pain inventory questionnaire which the patient would have to complete at this time point.

  • Impact on quality of life [ Time Frame: At 1 month after surgery ]
    The impact of the mastectomy on Quality of life of the patient would be assessed from the EORTC-QLQ 30 questionnaire completed by the patient

  • Impact on daily function [ Time Frame: At 4 months after surgery ]
    How the pain per se affects day to day functioning of the patient.The impact of pain on daily life will be identified from the Brief Pain inventory questionnaire which the patient would have to complete at this time point.

  • Impact on quality of life [ Time Frame: At 4 months after surgery ]
    The impact of the mastectomy on the quality of life of the patient would be assessed from the EORTC-QLQ 30 questionnaire completed by the patient at his time point.

  • Impact on daily function [ Time Frame: At 6 months after surgery ]
    How the pain per se affects day to day functioning of the patient .The impact of pain on daily life will be identified from the Brief Pain inventory questionnaire which the patient would have to complete at this time point.

  • Impact on quality of life [ Time Frame: At 6 months after surgery ]
    the impact of teh mastectomy on the quality of life of the patient would be assessed from the EORTC-QLQ 30 questionnaire completed by the patient at this time point.


Estimated Enrollment: 120
Actual Study Start Date: March 6, 2017
Estimated Study Completion Date: September 6, 2018
Estimated Primary Completion Date: March 6, 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Non interventional study
    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
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients scheduled for undergoing surgery for breast cancer conservative and radical and willing to participate will be enrolled in the study after obtaining a written informed consent
Criteria

Inclusion Criteria:

  • Female patient undergoing mastectomy simple radical with or without axilla dissection
  • Literate and can read and write in either English, Hindi, Marathi
  • Willing to fill forms and post them and/or answer questions on phone

Exclusion Criteria:

  • Refusal of consent
  • Patient who has previously undergone major surgery around breast and chest wall
  • Benign breast pathology
  • Patient's with impaired cognitive function
  • Emergency surgery
  • PECs block study (PECTORALIS BLOCK)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067922


Contacts
Contact: APARNA S CHATTERJEE, MD,FCARCSI 022 24177000 ext 7051 aparnasanjay@hotmail.com
Contact: BARNALI KAKATI, MBBS 91 8828 058953 barnalikakati01@gmail.com

Locations
India
Tata Memorial Centre Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Aparna S Chatterjee, MD, FCARCSI    022 24177000 ext 7051    aparnasanjay@hotmail.com   
Contact: Barnali Kakati, MBBS    91 8828 058953    barnalikakati01@gmail.com   
Principal Investigator: Aparna S Chatterjee, MD,FCARCSI         
Sub-Investigator: Barnali Kakati, MBBS         
Sub-Investigator: Nita Nair, MS, MCH         
Sponsors and Collaborators
Tata Memorial Centre
Investigators
Principal Investigator: APARNA S CHATTERJEE, MD,FCARCSI Tata Memorial Centre
  More Information

Publications:

Responsible Party: Dr Aparna Chatterjee, Professor, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT03067922     History of Changes
Other Study ID Numbers: TataMC
First Submitted: February 10, 2017
First Posted: March 1, 2017
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Aparna Chatterjee, Tata Memorial Centre:
Mastectomy
Pain
Severity
Life quality

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders