Role of Exercise in Breast Cancer Patient Undergoing Treatment

NCT05009849 | Active Not Recruiting

• 1 other identifier: 735
• Study Type: interventional
• Target: 850
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  To assess the effect of yoga on disease free survival in women breast cancer.

  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 (5)

• Assess the impact of Yoga on inflammatory cytokines and cell free chromatin

  From randomization to 12 months

• Pain assessment

  from randomization to 60 months

• Quality of life assessment

  from randomization to 60 months

• Improvements in Lung Function

  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.

• Improvements in Overall survival

  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

Study Arms (2)

Exercise I

EXPERIMENTAL

Yogic and Routine Exercises (referred to as exercise I) Phase I: 1-7 days (Minimum attendance 4 days), Phase II: 8 - 14 days (Minimum attendance 4 days), Phase III: at 6-9 months or 12-15 months 1 year up gradation of exercises at 6-9 month or 12-15 months 1 year (Depending upon compliance to phase II exercises) Objective assessment at baseline, 14 days, 6-9, 12-15, 18-21, 36-39 and 54-57 months Exercise evaluation will be done at 6-9, 12-15, 30-33, 48-51 and 66-69 months

Other: Yoga Exercises

Exercise II

ACTIVE COMPARATOR

Objective assessment at baseline, 14 days, 6-9, 12-15, 18-21, 36-39 and 54-57 months

Other: Yoga Exercises

Interventions

Yoga Exercises OTHER

The exercises in the Exercise I arm (Yoga and conventional exercises) will be upgraded to Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase I and II. Patients will be assessed at 6-9 months for compliance to phase II exercises. Only if patients are fulfilling the criteria for accuracy, sequence and duration of phase II exercises, will they be taught phase III exercises. Patients who are unable to do phase II exercises accurately or demonstrate non compliance to the exercise routine at first follow up visit/ 6-9 months will be re taught phase II exercises. These patients will be upgraded to phase III only if able to perform phase II adequately at assessment. Six months after completion of phase III exercises, patients will be assessed for compliance to phase III exercises. These women's will be assessed at the subsequent 6-9 month follow up and compliance will be evaluated.

Exercise I; Exercise II

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Womens with breast Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tata Memorial Centre: lead

Related Publications (36)

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Study Officials

• nita nair, Mch

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Surgeon (Breast Surgical Oncology Services)

Model Details: Arm I: Yoga \& Conventional Exercises Arm II: Conventional Exercises All eligible patients will be randomly to either of the arm as mentioned above.

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 18, 2021
• Study Start: November 23, 2010
• Primary Completion: May 24, 2025
• Study Completion (Estimated): May 30, 2030
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share