Effect of a structured exercise programme in improving outcome in terms of shoulder function after breast cancer surgery

Phase 2/3

Not yet recruiting

• Conditions: Malignant neoplasm of breast,

• Registration Number: CTRI/2025/03/083738
• Lead Sponsor: Dr Avisikta Mallick

Brief Summary

The study has been proposed with an aim to study the impact of structured exercise programme in comparison to usual care on postoperative functional outcomes in patients with breast cancer undergoing curative intent surgery. This has been supported with the background of improved post operative functional outcome in terms of improved DASH score, Quality of life in terms of FACT B+4 score and improved metabolic syndrome score (MetS z score) and improved fatigue score (FACT-F score). All women undergoing breast cancer surgery in our institute will be included in the study. Women already having some shoulder dysfunction or with metastatic breast carcinoma will be excluded from the study.One structured exercise programme will be developed which will be

validated among the current study population and it can be delivered by the treating surgeon himself/herself to all the breast cancer survivors for their long term functional recovery.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-26
• Study Start: 2025-04-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• Eastern Clinical Oncology Group- Performance score (ECOG-PS): 0-2 2.
• Biopsy proven- non metastatic breast carcinoma 3.
• Undergoing surgery with curative intent.

Exclusion Criteria

• 1.Second primary/ recurrent cancer.
• Patients with severe comorbidities, distant metastasis 3.Patients already having shoulder disability due to preexisting shoulder joint pathology 4.
• Patient’s current physical or mental condition not allowing to undergo a vigorous exercise programme 5.
• Patients not willing to participaTe.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess whether the structured exercise program (SEP) improves the	3 and 6 months
functional morbidity in the form of DASH (Disability of Arm, Hand, and Shoulder) score at 3	3 and 6 months
and 6 months among breast cancer patients undergoing curative-intent surgery.	3 and 6 months

Secondary Outcome Measures

Name	Time	Method
1. To compare short- and long-term morbidity (wound related, pain, fatigue, lymphedema,	etc. between two groups

Trial Locations

Locations (1)

AIIMS, Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

AIIMS, Jodhpur

🇮🇳Jodhpur, RAJASTHAN, India

Dr Avisikta Mallick

Principal investigator

8017999074

dravisiktamallick@gmail.com