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NCT Number: NCT05009849

Role of Exercise in Breast Cancer Patient Undergoing Treatment

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Patients

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Disease-free survival

    Time frame: 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.

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

Secondary outcomes

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

    Time frame: From randomization to 12 months

    The impact of yoga on inflammatory markers will be assessed by using serum samples to check the concentration of IL2, TNF alpha, IL6, IL8, IL10 and C reactive protein by using ELISA technique.

  2. Pain assessment

    Time frame: from randomization to 60 months

    To assess the effect of yoga using Pain Assessment chart questionnaire, having score scale from scale 0 to 10 wherein 0 represent "No Pain" and 10 represent "Worst Possible Pain"

  3. Quality of life assessment

    Time frame: from randomization to 60 months

    To assess the effect of yoga using Quality of life questionnaire (QLQ-30, BR-23, Spirituality & BFI having score scale from 1-4, wherein 1 represents 'Not at All' and 4 'very much'

  4. Improvements in Lung Function

    Time frame: 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.

    To assess the effect of yoga in improving the Lung Function by evaluating Pulmonary Function Teast (PFT) readings.

  5. Improvements in Overall survival

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Official study title

Randomized Controlled Evaluating the Role of Exercise in Women Undergoing Treatment for Breast Cancer

Important dates

Study start
2010
Primary completion
2025
Study completion
2030
First posted
Aug 18, 2021
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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