Pilot Study of Aerobic Exercise During Immune Checkpoint Inhibitor Therapy in Early-Stage TNBC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if participating in a supervised exercise program can help participants with early-stage TNBC who are receiving ICI therapy before undergoing breast surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
female and male participants 18 years or older and willing to provide Informed Consent
clinical stage 2 or 3 TNBC (estrogen receptor and progesterone receptor ≤ 10% by immunohistochemistry (IHC) and human epidermal growth factor-2 (HER2) negative (IHC 0, IHC1+, or IHC 2+ with negative fluorescence in situ hybridization))
Physically able to walk independently without assistive device and able to march in place for 30 seconds without assistive device
Eastern Co-Operative Oncology Group (ECOG) Performance Status 0-1
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Exercise
Other interventionCardiorespiratory training via treadmill walking for 30 minutes; participants will be supervised by a trained exercise physiologist.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Acute cardiorespiratory exercise programExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adherence
Feasibility will be measured by adherence to both exercise frequency and time (duration/intensity) at the supervised sessions.
Time frame
Approximately 8 weeksSecondary outcomes
1
Circulating immune (CD8+ T) cells in the peripheral blood
Change of CD8+ T cells in the peripheral blood from baseline (pre-exercise) to post-exercise state
Time frame
Approximately 8 weeksOther outcomes
1
Other blood-based circulating immune cells pre-, during-, and post-exercise
NK cells, T regulatory (Treg) cells, markers of T cell exhaustion and immunosenescence (CD57, CD45-RA, PD1, KLRG1, CTLA-4)
Time frame
Approximately 8 weeks2
VO2 peak/max
peak oxygen uptake
Time frame
Approximately 8 weeks3
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (general cancer)
This is a Patient-Reported Outcome to measure health-related quality of life in patients with cancer. The instrument consists of 30 items comprising five functional scales (physical, role, emotional, cognitive, and social functioning), one global health status/quality of life scale, three multi-item symptom scales (fatigue, pain, nausea/vomiting), and several single-item symptom measures (e.g., dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).Responses are scored and transfored to a 0-100 scale. Responses are scored and linearly transformed to a 0-100 scale. For functional scales and the global health status/quality of life scale, higher scores indicate better functioning or quality of life. For symptom scales and single-item measures, higher scores indicate greater symptom severity or burden.
Time frame
Approximately 8 weeks4
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BR42 (breast-specific module)
This is a Patient-Reported Outcome to measure of quality of life patients with breast cancer. The instrument includes multi-item and single-item scales assessing domains such as systemic therapy side effects, breast and arm symptoms, body image, sexual functioning, sexual enjoyment, future perspective, and treatment-related symptoms. Scores are linearly transformed to a 0-100 scale. For functional scales (e.g., body image, sexual functioning, future perspective), higher scores indicate better functioning. For symptom scales/items (e.g., breast symptoms, systemic therapy side effects), higher scores indicate greater symptom burden or severity.
Time frame
Approximately 8 weeksSponsors and contacts
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Source ClinicalTrials.gov