Comparison between two different schedules of radiotherapy by modern radiotherapy technique in terms of side effects and quality of life in breast cancer patients

Phase 2

Completed

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2021/05/033625
• Lead Sponsor: Chittaranjan National Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-05-07
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

1.Age greater than equal to 18years and less than 70years.

2.Female breast cancer patients.

3.Histopathologically proven Infiltrating Ductal and Infiltrating Lobular carcinoma of the

breast.

4.Patients who will undergo Modified Radical Mastectomy with adequate Axillary

Dissection in our institution and will be indicated for post mastectomy chest wall

radiotherapy.

5.Breast carcinoma patients with documented ER,PR and Her2neu status.

6.No other primary malignancy in any other parts of the body.

7.No history of previous any chest wall irradiation.

8.Eastern Cooperative Oncology Group(ECOG) Performance status 0-2.

9.Patients without any serious co-morbidities like IHD,CVA,Coagulation and Bleeding

disorders.

10.Patients with normal haematological findings of Hb greater than 10gm/dl,TLC greater than 4000/cumm and

Platelet Count of greater than 1lacs/cumm.

12.Patients with normal Kidney and Liver Function Test.

13.Patients with normal Pulmonary Function Test.

14.Patients who will give consent to participate in the study.

Exclusion Criteria

1.Age <18 years and >70years.

2.Male breast cancer patients.

3.Patients with a histopathological finding other than Invasive Lobular and Ductal

Carcinoma.

4.Breast carcinoma patients withdistant metastasis.

5.Patients with inoperable,clinically fixed,and matted lymph nodes.

6.Patients with inadequate or no axillary dissection.

7.Patients with any other primary malignant tumour.

8.Patients with any chronic dermatological or connective tissue disorders that may interfere

with radiation induced acute skin toxicity assessment.

9.History of any previous chest wall irradiation.

10.Patients with Eastern Cooperative Oncology Group(ECOG)Performance Score >2.

11.Patients with serious active comorbidities like:

History of unstable angina and/or congestive heart failure requiring hospitalization in the

last 6months.

**History of myocardial infarction within the last 6months.

Acute or chronic bacterial or fungal infection requiring intravenous antibiotics at the

time of patient registration.

Chronic Obstructive Pulmonary Disease with abnormal Pulmonary Function Test.

Clinical jaundice and bleeding disorders

12.Patients with deranged Liver and Kidney function test results

13.Patients who are HBsAg,Anti HCV antibody and HIV reactive.**

Study & Design

• Study Type: Interventional
• Study Design: Not specified