Role of Exercise in Breast Cancer Patient Undergoing Treatment

Breast Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05009849
• Other study ID #: 735
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 23, 2010
• Est. completion date: May 30, 2030

Study information

• Verified date: October 2022
• Source: Tata Memorial Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 850
• Est. completion date: May 30, 2030
• Est. primary completion date: May 24, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Patients
• Breast Neoplasms

Intervention

Other:
• Yoga Exercises
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

References & Publications (36)

Andrykowski MA, Curran SL, Lightner R. Off-treatment fatigue in breast cancer survivors: a controlled comparison. J Behav Med. 1998 Feb;21(1):1-18. — View Citation

Arndt V, Merx H, Stürmer T, Stegmaier C, Ziegler H, Brenner H. Age-specific detriments to quality of life among breast cancer patients one year after diagnosis. Eur J Cancer. 2004 Mar;40(5):673-80. — View Citation

Ashing-Giwa KT, Padilla G, Tejero J, Kraemer J, Wright K, Coscarelli A, Clayton S, Williams I, Hills D. Understanding the breast cancer experience of women: a qualitative study of African American, Asian American, Latina and Caucasian cancer survivors. Ps — View Citation

Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM. Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst. 2012 Jun 6;104(11):815-40. doi: 10.1093/jnci/djs207. Epu — View Citation

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. — View Citation

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. Epub 2005 Feb 4. — View Citation

Cella D, Fallowfield L, Barker P, Cuzick J, Locker G, Howell A; ATAC Trialistsa9 Group. Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early br — View Citation

Coleman MP, Rachet B, Woods LM, Mitry E, Riga M, Cooper N, Quinn MJ, Brenner H, Estève 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. — View Citation

Courneya KS, Friedenreich CM, Sela RA, Quinney HA, Rhodes RE, Handman M. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Psychooncology. 2003 Jun;12(4):357-74. — View Citation

Coyne JC, Lepore SJ, Palmer SC. Efficacy of psychosocial interventions in cancer care: evidence is weaker than it first looks. Ann Behav Med. 2006 Oct;32(2):104-10. Review. — View Citation

Cramp F, Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006145. doi: 10.1002/14651858.CD006145.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;11:CD006145. — View Citation

Demark-Wahnefried W, Clipp EC, Morey MC, Pieper CF, Sloane R, Snyder DC, Cohen HJ. Lifestyle intervention development study to improve physical function in older adults with cancer: outcomes from Project LEAD. J Clin Oncol. 2006 Jul 20;24(21):3465-73. — View Citation

Eversley R, Estrin D, Dibble S, Wardlaw L, Pedrosa M, Favila-Penney W. Post-treatment symptoms among ethnic minority breast cancer survivors. Oncol Nurs Forum. 2005 Mar 5;32(2):250-6. — View Citation

Ganz PA, Guadagnoli E, Landrum MB, Lash TL, Rakowski W, Silliman RA. Breast cancer in older women: quality of life and psychosocial adjustment in the 15 months after diagnosis. J Clin Oncol. 2003 Nov 1;21(21):4027-33. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Kornblith AB, Ligibel J. Psychosocial and sexual functioning of survivors of breast cancer. Semin Oncol. 2003 Dec;30(6):799-813. Review. — View Citation

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).

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. Epub 2006 Jun 14. — View Citation

Löf M, Bergström K, Weiderpass E. Physical activity and biomarkers in breast cancer survivors: a systematic review. Maturitas. 2012 Oct;73(2):134-42. doi: 10.1016/j.maturitas.2012.07.002. Epub 2012 Jul 26. Review. — View Citation

Long Parma D, Hughes DC, Ghosh S, Li R, Treviño-Whitaker RA, Ogden SM, Ramirez AG. Effects of six months of Yoga on inflammatory serum markers prognostic of recurrence risk in breast cancer survivors. Springerplus. 2015 Mar 26;4:143. doi: 10.1186/s40064-0 — View Citation

Mittra I, Khare NK, Raghuram GV, Chaubal R, Khambatti F, Gupta D, Gaikwad A, Prasannan P, Singh A, Iyer A, Singh A, Upadhyay P, Nair NK, Mishra PK, Dutt A. Circulating nucleic acids damage DNA of healthy cells by integrating into their genomes. J Biosci. — View Citation

Mittra I, Samant U, Sharma S, Raghuram GV, Saha T, Tidke P, Pancholi N, Gupta D, Prasannan P, Gaikwad A, Gardi N, Chaubal R, Upadhyay P, Pal K, Rane B, Shaikh A, Salunkhe S, Dutt S, Mishra PK, Khare NK, Nair NK, Dutt A. Cell-free chromatin from dying canc — View Citation

Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. Epub 2007 Sep 4. — View Citation

Mock V, Frangakis C, Davidson NE, Ropka ME, Pickett M, Poniatowski B, Stewart KJ, Cameron L, Zawacki K, Podewils LJ, Cohen G, McCorkle R. Exercise manages fatigue during breast cancer treatment: a randomized controlled trial. Psychooncology. 2005 Jun;14(6 — View Citation

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. Epub 2005 Oct 13. Review. — View Citation

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. — View Citation

Northouse LL, Caffey M, Deichelbohrer L, Schmidt L, Guziatek-Trojniak L, West S, Kershaw T, Mood D. The quality of life of African American women with breast cancer. Res Nurs Health. 1999 Dec;22(6):449-60. — View Citation

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. — View Citation

Segal R, Evans W, Johnson D, Smith J, Colletta S, Gayton J, Woodard S, Wells G, Reid R. Structured exercise improves physical functioning in women with stages I and II breast cancer: results of a randomized controlled trial. J Clin Oncol. 2001 Feb 1;19(3) — View Citation

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. Review. — View Citation

Vacek PM, Winstead-Fry P, Secker-Walker RH, Hooper GJ, Plante DA. Factors influencing quality of life in breast cancer survivors. Qual Life Res. 2003 Aug;12(5):527-37. — View Citation

Wallgren A. Late effects of radiotherapy in the treatment of breast cancer. Acta Oncol. 1992;31(2):237-42. Review. — View Citation

Watson M, Homewood J, Haviland J, Bliss JM. Influence of psychological response on breast cancer survival: 10-year follow-up of a population-based cohort. Eur J Cancer. 2005 Aug;41(12):1710-4. — View Citation

* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From randomization to 12 months
Secondary	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"	from randomization to 60 months
Secondary	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'	from randomization to 60 months
Secondary	Improvements in Lung Function	To assess the effect of yoga in improving the Lung Function by evaluating Pulmonary Function Teast (PFT) readings.	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.
Secondary	Improvements in Overall survival	To assess the effect of yoga on overall free survival in women breast cancer.	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