SWOG clinical trial number
S1008
Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II
Closed
Phase
Accrual
100%
Abbreviated Title
Physical activity & dietary change weight loss in breast & colorectal survivors Ph II
Activated
03/01/2012
Closed
07/01/2014
Participants
Limited: Institutions Listed on the Title Page
Research committees
Cancer Survivorship
Breast Cancer
Gastrointestinal Cancer
Eligibility Criteria Expand/Collapse
Women with previous diagnosis of breast cancer or colorectal cancer (Stage I, II, or III w/no evidence of metastatic disease) and no evidence of disease or history of metastases at reg; post-menopausal (>/= 12 months since last menses OR prior bilateral oophorectomy OR previous hysterectomy with one of both ovaries left in place AND FSH values consistent with institutional normal values. If under age 55, FSH levels must be obtained within 28 days prior to reg); 90 days-7 years post-surgery, chemotherapy and radiation therapy (current hormonal therapy allowed for breast cancer participants, other concurrent cytotoxic therapies including Herceptin are not allowed); BMI >/= 25 kg/m2 within 28 days; considered sedentary (< 150 min of moderate or vigorous physical activity/week); Zubrod PS of 0; No abnormal changes on cardiovascular stress test by EKG within 3 months prior to reg; No evidence of uncontrolled hypertension that is not effectively managed with intervention; Participants with diabetes, pre-diabetes, and/or metabolic syndrome: HgbA1C </= 8 within 28 days prior to reg; No weight loss surgery; No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for >/= 5 years; Not active smoke within 90 days prior to reg; Willing to submit blood samples for biomarkers and given option to consent to banking; Willing and able to attend Curves® fitness center at least 3x/week for 12 months; Regular access to internet for 3 questionnaires and nutrition e-mails; Must be able to understand, speak, and read English; Must have phone and agree to participate in 14 behavioral counseling sessions and 9 phone interviews; Physician clearance to participate in weight loss and exercise prior to enrollment within 60 days of reg.
Publication Information Expand/Collapse
2018
PMid: PMID30272836 | PMC number: PMC6611675
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SWOG Clinical Trial Number
S2206
A Randomized trial of neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone for Adults with MammaPrint Ultrahigh (MP2) hormone receptor (HR) positive /Human Epidermal Growth Factor receptor (HER2) negative stage II-III breast cancer
Research Committee(s)
Breast Cancer
Symptom Control and Quality of Life
Activated
10/30/2023
Accrual
9%
Open
Phase
SWOG Clinical Trial Number
S2212
TIL Adapted Neo adjuvant Chemotherapy Optimization in Triple negative breast cancer (SCARLET)
Research Committee(s)
Breast Cancer
Activated
07/21/2023
Accrual
16%
Open
Phase
SWOG Clinical Trial Number
CTSU/NRG-BR007
A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score </= 18 Breast Cancer
Research Committee(s)
Breast Cancer
Activated
06/07/2021
Open
Phase