Clinical trial NCT05009849: Role of Exercise in Breast Cancer Patient Undergoing Treatment
Official title: Randomized Controlled Evaluating the Role of Exercise in Women Undergoing Treatment for Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Patients
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 850
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm I: Yoga \& Conventional Exercises Arm II: Conventional Exercises All eligible patients will be randomly to either of the arm as mentioned above.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomized controlled trial to evaluate the impact of yoga on QOL is also powered to evaluate the impact of yoga on survival. Study involves various phases of yoga(divided in three phases: Phase I/II/III) during treatment and survivorship, with a comparative analysis of different time points and the response to yoga, which will help integrating yoga as a complementary modality. Also, this study will help identify the long term and short term effects of this therapy in breast cancer patients and survivors.

One of the main differences between yoga and other forms of physical activity is that yoga exercises oppose violent muscle movement and is designed to counteract fatigue through relaxation and breathing. 6 monthly Follow Up will be for 5 years followed by yearly follow up.

Detailed description: Women with breast cancer are constantly exploring measures in addition to ongoing conventional therapy to relieve disease related symptoms, minimize side effects associated with conventional treatment, reduce their risk of recurrence and enhance their prospects for survival. Breast cancer survival rates have considerably improved over the years with the advent of new therapeutic measures and early detection. However its treatment sequelae are associated with significant changes in quality of life (QOL) and well being. Fatigue is one of the most prevalent QOL concerns, affecting 30% to 70% of breast cancer survivors.

Yoga is based on the practice of physical postures, breathing techniques and meditation. Philosophically, it aims at increasing the body's ability to master the mind with the goal of spiritual awareness and connection. A randomized trial of yoga in women with breast cancer undergoing radiation therapy demonstrated an improvement in impact of events scale at 3 months suggesting that the more intrusive thoughts at 1 month the greater the finding of meaning in cancer by 3 months.

* This is the first randomized controlled trial of this magnitude (850 women), which in addition to testing the impact of yoga on QOL is also powered to evaluate the impact of yoga on survival
* This is a longitudinal study measuring various phases of yoga during treatment and survivorship, with a comparative analysis of different time points and the response to yoga , which will help integrating yoga as a complementary modality
* Also, this study will help identify the long term and short term effects of this therapy in breast cancer patients and survivors
* The exercises are carefully designed keeping the phase of treatment or recovery of the breast cancer patient/survivor in focus.
* Chronic ailments have also been kept in mind (eg: which impede mobility or flexibility ie: spondylosis)
* One of the main differences between yoga and other forms of physical activity is that yoga exercises oppose violent muscle movement and is designed to counteract fatigue through relaxation and breathing.

Eligibility criteria: Inclusion Criteria:

* Women with unilateral breast cancer
* Age 18-65 years

Exclusion Criteria:

* Metastatic breast cancer
* Pregnant Women
* Women with physical limitations to perform exercises
* Previous history of cancer

Primary outcomes:
measure: Disease-free survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
Secondary outcomes:
measure: Assess the impact of Yoga on inflammatory cytokines and cell free chromatin
timeFrame: From randomization to 12 months
measure: Pain assessment
timeFrame: from randomization to 60 months
measure: Quality of life assessment
timeFrame: from randomization to 60 months
measure: Improvements in Lung Function
timeFrame: The FEV1/ FVC ratio and the value will be checked, if the value is within 80% to 120%, it will be considered as normal (95 percent confidence interval). From randomization until 12 months.
measure: Improvements in Overall survival
timeFrame: from the date of randomization to the date of death or censored at the date of last follow up for the patients who are alive or lost to follow up, until 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Tata Memorial Centre
name: nita nair, Mch
role: PRINCIPAL_INVESTIGATOR
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