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. 2012 Aug 15;2012(8):CD008465. doi: 10.1002/14651858.CD008465.pub2

Banerjee 2007.

Study characteristics
Methods Study design: RCT
Number randomized: 68; 35 to the exercise group and 33 to the control group
Study start and stop dates: not reported
Length of intervention: 6 weeks
Length of follow‐up: to end of the intervention
Participants Type cancer: breast cancer
Stage, n (%)
  • exercise group: Stage II, 16 (46%); Stage III, 19 (54%)

  • control group: Stage II, 10 (43%); Stage III, 13 (57%)


Time since cancer diagnosis: not reported
Time in active treatment: all patients received 6 weeks of radiation therapy for a total dosage of 50.4 Gy. Some patients apparently received concurrent chemotherapy but how many is not stated since previous chemotherapy and current concomitant chemotherapy are not distinguished
Inclusion criteria:
  • "recently operated breast cancer" (not further specified)

  • 30 to 70 years old

  • Zubrod performance status 0 to 2 (ambulatory > 50% of time)

  • 'high school' education

  • treatment plan of radiation therapy or both adjuvant radiation therapy and chemotherapy

  • consent to participate


Eligibility criteria related to interest or ability, or both, to exercise:
  • none


Exclusion criteria:
  • concurrent medical condition likely to interfere with the treatment

  • major psychiatric disorder, neurologic illness, or autoimmune disorder

  • cardiovascular illness

  • known metastases

  • exposure to other mutagens, smoking, or alcohol within 3 months of pre‐radiation blood donation


Gender: female
Current age, mean (SD) years:
  • exercise group: 47 (1.1) years

  • control group: 43 (1.5) years


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level: all required to have completed 'high school'
SES: not reported
Employment status: not reported
Comorbidities: not reported
Past exercise history: not reported
On hormone therapy: not reported
Interventions 35 participants assigned to the exercise intervention, including:
  • integrated yoga program

  • special techniques for cancer patients, including guided imagery of cancer cells, positive thought provocations, and chanting of various sounds


Type exercise (aerobic/anaerobic): aerobic and anaerobic
Intensity of the experimental exercise intervention: not reported
Frequency: not reported
Duration of individual sessions: 90 minutes
Duration of exercise program: 6 weeks
Total number of exercise sessions: not reported
Format: group
Facility: facility and home practice
Professionally led: professionally led by yoga instructors and trainers
Adherence: not reported
33 participants assigned to control group, including:
  • supportive counseling and advised to "take light exercise" ‐ described as going on for 6 weeks but no further information provided


Contamination of control group: not reported
Outcomes No primary outcome identified. Outcomes included:
  • anxiety, assessed using the HADS

  • depression, using the HADS

  • psychological stress, assessed using the Perceived Stress Scale

  • DNA damage assessed through blood alkaline single‐cell gel electrophoresis


Outcomes were measured at baseline and at 6 weeks:
  • exercise group: n = 35 at baseline, n = 35 at 6 weeks

  • control group: n = 23 at baseline, n = 23 at 6 weeks


Subgroup analysis: none
Adverse events: not reported
Notes Country: India
Funding: Atomic Energy Radiation Board of India; SVYASA University Bangalore, India; National Medical Research Council, Singapore
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random number table
 
Allocation concealment (selection bias) Low risk Group assignments sent to clinics of the recruiting hospitals
Blinding of participants and personnel (performance bias)
All outcomes High risk Owing to the nature of the intervention, it was not possible to conceal allocation to the intervention from the participants
Blinding of outcome assessment (detection bias)
All outcomes High risk Allocation to the intervention was not concealed from the study personnel
Incomplete outcome data (attrition bias)
All outcomes High risk All 10 attritions experienced in the study were from the control group. The attrition occurred either immediately after random assignment or during the course of the study
Selective reporting (reporting bias) Low risk There appears to be no selective reporting of outcomes
Other bias Low risk The trial appears to be free of other problems that could put it at a high risk of bias