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Breast Cancer PatientsNCT05009849

Role of Exercise in Breast Cancer Patient Undergoing Treatment

A study testing Yoga Exercises in people with Breast Cancer Patients, run by Tata Memorial Centre.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Breast Cancer Patients
What is being tested?
Yoga Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
850 participants
Where
No sites listed yet
Study dates
23 Nov 2010to 30 May 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

About this study

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

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.

Read the 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.
Being tested
Yoga Exercises

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga ExercisesOther

    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.

Study groups in NCT05009849
Study groupRoleWhat they receive
Exercise IExperimentalYogic 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
Receives: Other: Yoga Exercises
Exercise IIActive comparatorObjective assessment at baseline, 14 days, 6-9, 12-15, 18-21, 36-39 and 54-57 months
Receives: Other: Yoga Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

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

    Measured: 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)

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

    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.

    Measured: From randomization to 12 months

  2. Pain assessment

    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"

    Measured: from randomization to 60 months

  3. Quality of life assessment

    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'

    Measured: from randomization to 60 months

  4. Improvements in Lung Function

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

    Measured: 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.

  5. Improvements in Overall survival

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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start23 Nov 2010
  3. Primary completion24 May 2025 (estimated)
  4. Study completion30 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
850 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009849
Sponsor's protocol ID
735
Status last verified
Oct 2022
First submitted
29 Jul 2021
Last updated
20 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Knols R, Aaronson NK, Uebelhart D, Fransen J, Aufdemkampe G. Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials. J Clin Oncol. 2005 Jun 1;23(16):3830-42. doi: 10.1200/JCO.2005.02.148.

    PubMed 15923576

  • Lemieux J, Topp A, Chappell H, Ennis M, Goodwin PJ. Economic analysis of psychosocial group therapy in women with metastatic breast cancer. Breast Cancer Res Treat. 2006 Nov;100(2):183-90. doi: 10.1007/s10549-006-9249-1. Epub 2006 Jun 14.

    PubMed 16773438

  • Jones SB, Thomas GA, Hesselsweet SD, Alvarez-Reeves M, Yu H, Irwin ML. Effect of exercise on markers of inflammation in breast cancer survivors: the Yale exercise and survivorship study. Cancer Prev Res (Phila). 2013 Feb;6(2):109-18. doi: 10.1158/1940-6207.CAPR-12-0278. Epub 2012 Dec 4.

    PubMed 23213072

  • L. Cohen, K. D. Chandwani, G. Perkins, B. Thornton, B. Arun, N. V. Raghuram, H. R. Nagendra Randomized trial of yoga in women with breast cancer. Undergoing radiation treatment: Long-term effects. J Clin Oncol 26: 2008 (May 20 suppl; abstr 9639).

  • Newman V, Rock CL, Faerber S, Flatt SW, Wright FA, Pierce JP. Dietary supplement use by women at risk for breast cancer recurrence. The Women's Healthy Eating and Living Study Group. J Am Diet Assoc. 1998 Mar;98(3):285-92. doi: 10.1016/s0002-8223(98)00068-6.

    PubMed 9508010

  • Risberg T, Lund E, Wist E, Kaasa S, Wilsgaard T. Cancer patients use of nonproven therapy: a 5-year follow-up study. J Clin Oncol. 1998 Jan;16(1):6-12. doi: 10.1200/JCO.1998.16.1.6.

    PubMed 9440716

  • Beisecker A, Cook MR, Ashworth J, Hayes J, Brecheisen M, Helmig L, Hyland S, Selenke D. Side effects of adjuvant chemotherapy: perceptions of node-negative breast cancer patients. Psychooncology. 1997 Jun;6(2):85-93. doi: 10.1002/(SICI)1099-1611(199706)6:23.0.CO;2-T.

    PubMed 9205966

  • Wallgren A. Late effects of radiotherapy in the treatment of breast cancer. Acta Oncol. 1992;31(2):237-42. doi: 10.3109/02841869209088909.

    PubMed 1622640

  • Gyenes G, Fornander T, Carlens P, Rutqvist LE. Morbidity of ischemic heart disease in early breast cancer 15-20 years after adjuvant radiotherapy. Int J Radiat Oncol Biol Phys. 1994 Mar 30;28(5):1235-41. doi: 10.1016/0360-3016(94)90500-2.

    PubMed 8175411

  • Irvine D, Brown B, Crooks D, Roberts J, Browne G. Psychosocial adjustment in women with breast cancer. Cancer. 1991 Feb 15;67(4):1097-117. doi: 10.1002/1097-0142(19910215)67:43.0.co;2-z.

    PubMed 1991258

  • Coleman MP, Rachet B, Woods LM, Mitry E, Riga M, Cooper N, Quinn MJ, Brenner H, Esteve J. Trends and socioeconomic inequalities in cancer survival in England and Wales up to 2001. Br J Cancer. 2004 Apr 5;90(7):1367-73. doi: 10.1038/sj.bjc.6601696.

    PubMed 15054456

  • Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005 Mar 26;330(7493):702. doi: 10.1136/bmj.38343.670868.D3. Epub 2005 Feb 4.

    PubMed 15695497

  • Kornblith AB, Ligibel J. Psychosocial and sexual functioning of survivors of breast cancer. Semin Oncol. 2003 Dec;30(6):799-813. doi: 10.1053/j.seminoncol.2003.08.025.

    PubMed 14663780

  • Shapiro SL, Lopez AM, Schwartz GE, Bootzin R, Figueredo AJ, Braden CJ, Kurker SF. Quality of life and breast cancer: relationship to psychosocial variables. J Clin Psychol. 2001 Apr;57(4):501-19. doi: 10.1002/jclp.1026.

    PubMed 11255204

  • Mols F, Vingerhoets AJ, Coebergh JW, van de Poll-Franse LV. Quality of life among long-term breast cancer survivors: a systematic review. Eur J Cancer. 2005 Nov;41(17):2613-9. doi: 10.1016/j.ejca.2005.05.017. Epub 2005 Oct 13.

    PubMed 16226458

Questions about this trial

What is this clinical trial studying?

A study testing Yoga Exercises in people with Breast Cancer Patients, run by Tata Memorial Centre.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05009849, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.

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