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. Author manuscript; available in PMC: 2022 May 24.
Published in final edited form as: Nat Metab. 2020 Sep 14;2(9):849–857. doi: 10.1038/s42255-020-00277-4

Table:

Ongoing clinical trials of structured exercise therapy in cancer prevention and prognosis

Trial Design NCT# Sample size / Population Exercise Intervention Cancer-specific Endpoints
Post Diagnosis
Phase 3 Trials
 Intense Exercise for Survival Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL)88 Phase 3 RCT NCT02730338 N=866; advanced prostate cancer 2 years – individualized, progressive moderate to high intensity aerobic and resistance exercise. Supervised (Year 1) and home-based (Year 2) Primary: Overall survival

Secondary: Disease progression, program safety
 The Colon Health and Life-Long Exercise Change Trial (CHALLENGE)87 Phase 3 RCT NCT00819208 N=962; stage II/III colon cancer patients 3 years – combined behavior support with supervised / unsupervised activity sessions with goal to increase recreational physical activity up to 27 MET-hrs/wk Primary: Disease-free survival

Secondary: Overall survival
Other Trials
 Effect of Physical Exercise on Tumour Proliferation of Luminal B Breast Cancer Patients Case Control NCT03860740 N=60; operable and untreated HR+ HER2− breast cancer patients 2–3 wks prior to surgery - 60% to 100% VO2peak, 10 sessions minimum Primary: Tumour Proliferation (Ki67), Proliferation score (PAM50)

Secondary: change from baseline molecular subtypes (PAM50), intratumoural VEGF, HIF-1, cleaved caspase-3
 Exercise Treatment with Standard Therapy for Metastatic Breast Cancer Phase 1a/b NCT03988595 N=60; HR+ metastatic breast cancer 24 wks - 3 to 5x/wk - 4 escalated doses: 90 mins/wk, 150 mins/wk, 225 mins/wk, or 300 mins/wk Phase 1a (dose escalation):

Primary: Maximum feasible dose
Secondary: Change in circulating tumour DNA, tumour proliferation (Ki67), HR signaling

Phase 1b (dose expansion):

Primary: Change in circulating tumour DNA
Secondary: tumour proliferation (Ki67), HR signaling
 Exercise Interventions for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy (BENEFIT) 3-arm RCT NCT02999074 N=240; breast cancer patients scheduled for neoadjuvant chemotherapy 18 wks, 2 interventions:

Resistance exercise (2 x wk) - 8 machine-based exercises, each performed in 3 sets, 12 repetitions at 60–80% of one repetition maximum (1-RM);

or aerobic exercise (2 x wk) – up to 60–70% VO2peak		 Primary: Tumour Size - change from baseline (before start of neoadjuvant chemotherapy) to breast surgery

Secondary: CPS-EG score, pathological complete response
 Combination of Exercise and a Plant-Based Diet in Overweight Postmenopausal Women with Breast Cancer 2-arm RCT NCT04298086 N=62; HR+ HER2− stage I-III breast cancer patients receiving aromatase inhibitor 24 wks; 7 x wk to achieve the patient-specific goal energy expenditure in conjunction with a plant-based diet Primary: Change in breast aromatase levels

Secondary: Change in breast tissue gene expression
 Effects of Pre-Surgical Aerobic Training in Patients with Solid Tumours Phase 0 / 1a/b NCT03813615 N=78; Phase 0: early stage breast, endometrial and prostate cancer

Phase 1a/b: operable, untreated prostate cancer		 Phase 0: > 2 wks aerobic training - 150 mins/wk, 5 sessions/wk

Phase 1a.: > 2 wks aerobic training - 150 mins/wk, 225 mins/wk, 300 mins/wk, or 375 mins/wk; 3 to 6 sessions/wk

Phase 1b: Dose expansion		 Phase 1a. Maximal feasible dose with biological activity

Phase 1b. Further examination of tolerability and activity
Prevention
 Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue Single arm NCT03657628 N=60; premenopausal women with high breast density 12 wks - supervised, moderate-intensity aerobic exercise Primary: Proliferation (Ki67)
 Dose-Response of Aerobic Training in Women at High-Risk for Development of Breast Cancer 3-arm RCT NCT02494869 N=75; women at high risk for breast cancer (family history, atypical hyperplasia) 24 wks, 2 exercise doses:

150 minutes/wk aerobic training (3 sessions of 50 minutes) at 55–100% VO2peak;

or 300 minutes/wk aerobic training (5 sessions of 60 minutes) at 55–100% VO2peak		 Primary: Changes in gene expression patterns of non-neoplastic breast epithelial cells

Secondary: Changes in (epi)-genomic profile

Abbreviations: RCT: randomized control trial; HR: hormone receptor; HER2: human epidermal growth factor receptor 2; Met: metabolic equivalent of task; VO2peak: peak rate of oxygen consumption; CPS-EG: Clinical-Pathologic Stage score