Current Research Projects
1. Breast Cancer Weight Loss (BWEL)
BWEL is a randomized, controlled trial investigating whether weight loss after breast cancer diagnosis can reduce the risk of recurrence in women with overweight or obesity. BWEL compares the efficacy of a telephone-based, weight loss intervention plus health education materials vs health education materials alone on invasive disease-free survival in women with stage II-III breast cancer and a body mass index (BMI) >27 kg/m2. The study enrolled 3,181 participants from more than 600 sites across the US and Canada between late 2016 and 2021. In addition to the primary endpoint focused on disease recurrence and mortality, the trial will also evaluate the impact of the weight loss intervention on a broad assortment of secondary outcomes such as the incidence of comorbidities like diabetes and cardiovascular disease, health behaviors (diet and exercise patterns), body composition, side effects of cancer treatment, and quality of life. Results published in JAMA Oncology demonstrated that women randomized to the weight loss intervention lost 5.7% of baseline body weight vs controls. Abstracts presented at the European Society of Medical Oncology Congress and the San Antonio Breast Cancer Symposium demonstrated that the BWEL weight loss intervention led to increased physical activity and favorable changes in metabolic and inflammatory biomarkers.
Funding: NIH/NCI, Susan G Komen Foundation, Breast Cancer Research Foundation, American Cancer Society, American Institute for Cancer Research
Publications:
- Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer (Alliance A011401): Study Design (npj Breast Cancer, 2017)
- The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention (Obesity, 2022)
- Effect of a Weight Loss Intervention (WLI) on Exercise Behaviors in Women with Breast Cancer: Results from the Breast Cancer Weight Loss (BWEL) Trial (ESMO, 2024)
- Effect of a Weight Loss Intervention (WLI) on Metabolic and Inflammatory Biomarkers in Women with Obesity and Breast Cancer: Results from the Breast Cancer Weight Loss (BWEL) Trial (Alliance) (San Antonio Breast Cancer Symposium, 2024)
- Impact of a Weight Loss Intervention on 1-Year Weight Change in Women with Stage II/III Breast Cancer (JAMA Oncology, 2025)
- Trajectories of Daily Step Counts in Breast Cancer Survivors in the Breast Cancer Weight Loss (BWEL) Trial (AACR Annual Conference, 2025)
- Weight Trajectories in the Breast Cancer Weight Loss (BWEL) Trial (Alliance) (AACR Annual Conference, 2025)
- Intervention Adherence, Engagement and Tool Utilization in the Breast Cancer Weight Loss (BWEL) Trial by Race and Ethnicity (Alliance A011401) (ASCO Annual Conference, 2025)
- Association of Lifestyle Factors and Pathological Characteristics in Patients with Early Breast Cancer and Overweight/Obesity: Results from the Breast Cancer Weight Loss (BWEL) Trial (ASCO Annual Conference, 2025)
- Variation in Weight Loss and Intervention Engagement in the Breast Cancer Weight Loss (BWEL) Trial by Language and Ethnicity (Alliance) (San Antonio Breast Cancer Symposium, 2025)
2. Distance-Based Exercise to Preserve Function and Prevent Disability (DEFEND)
DEFEND is a new multicenter pilot study conducted through the Alliance for Clinical Trials in Oncology evaluating the feasibility of delivering a structured exercise program entirely through telehealth for patients with cancer receiving chemotherapy. This study will assess whether virtual exercise sessions, consisting of supervised resistance and aerobic exercise training, can successfully be delivered to patients, enrolled through academic and community oncology practices, during treatment. The study will also explore whether the exercise program can help patients maintain physical function, reduce fatigue, and prevent disability during treatment, providing critical data to inform the design of future trials.
MPI: Ligibel and Schmitz
Funding: NIH/NCI
News: New Alliance Clinical Trial Studies Impact of Exercise on Cancer Patients
3. Tele-Health Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE 65)
THRIVE-65 is a randomized trial evaluating the impact of an exercise intervention, paired with nutritional support, on chemotherapy completion rates and dose adjustments in women aged 65+ receiving chemotherapy for early-stage breast cancer. The study also evaluates the impact of the intervention on muscle mass, strength, quality of life, and elements of the geriatric assessment such as frailty. THRIVE-65 is part of the National Cancer Institute’s Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) Consortium, which seeks to evaluate the impact of exercise and nutrition interventions on treatment toxicity and chemotherapy outcomes in patients with a variety of cancers. The study is currently open to enrollment at Dana-Farber, Case Western Reserve University, the University of Pittsburgh, and Mount Nittany Medical Center.
MPI: Schmitz and Ligibel
Funding: NIH/NCI
Publications:
- TeleHealth Resistance exercise Intervention to preserve dose intensity and Vitality in Elder Breast Cancer Patients (THRIVE 65) (Contemporary Clinical Trials, 2025)
- Exercise and Nutrition to Improve Cancer Treatment-Related Outcomes (ENICTO) (JNCI, 2026)
4. Fasting and Exercise in Women with Hormone Receptor-Positive Advanced Breast Cancer (FastER)
The FastER trial tests the impact of exercise and/or prolonged overnight fasting on fatigue in women with metastatic, hormone receptor positive breast cancer who are being treated with endocrine therapy and a CDK 4/6 inhibitor. The project builds upon prior studies at Dana-Farber that demonstrated the feasibility of prolonged overnight fasting and exercise in women with advanced breast cancer. The FastER study will also look at the impact of exercise and fasting on quality of life, strength and circadian biology. Study interventions are delivered virtually through telehealth by trained coaches at Dana-Farber and the University of Miami.
MPI: Crane, Dieli-Conwright, and Ligibel
More on this trial: Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FastER)
5. Resistance and Aerobic Exercise for Prevention in Women with Dense Breasts (REP-D)
REP-D is a randomized trial investigating the impact of a structured, telehealth-based exercise program on circulating and tissue-based biomarkers in women at increased risk of breast cancer, with a primary goal of elucidating the biological mechanisms through which exercise impacts breast cancer risk and outcomes. Participants in the trial undergo sampling of blood and benign breast tissue to evaluate the impact of exercise on myokines and immune mediators linked to breast carcinogenesis. The study is conducted in collaboration with Drs. Bruce Spiegelman and Kate Blackmore, whose work has explored the biological basis of the favorable impact of exercise on many disease states in preclinical models.
Funding: Breast Cancer Research Foundation
1. Exercise in Metastatic Breast Cancer (EMBody)
EMBody is a randomized trial investigating exercise in a novel population with indolent metastatic breast cancer (no progression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensity aerobic and resistance training exercise for 16 weeks in this population will significantly improve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass), all established predictors of survival, and 2) patient- reported outcomes.
PI: Tarah J. Ballinger, MD, Indiana University
Funding: Susan G. Komen Breast Cancer Foundation
Publications:
1. Dance Study for Post-Surgical Pain in Breast Cancer Survivors
PI: Ligibel; Collaborator: Anna Krotinger, MD, Brigham and Women’s Hospital
2. Bridging Adolescent and Young Adult Sarcoma Survivors with Personalized Oncology Exercise Service (AYA-ONE): A Hybrid Type III Implementation Trial
MPI: Vinayak Venkataraman, MD, Chao Cao PhD, Dana-Farber Cancer Institute
3. Preventing Chemotherapy-Induced Peripheral Neuropathy with Acupuncture, A Randomized Controlled Trial (PACT Trial)
MPI: Weidong Lu, PhD, Dana-Farber Cancer Institute
4. Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
PI: Weidong Lu, PhD, Dana-Farber Cancer Institute