Intermittent Fasting for Breast Cancer Survivors with Obesity

Recruiting at 1 trial location

Overseen By Liza Wayland

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Anti-endocrine therapy

Must not be taking: Anti-obesity drugs, Antipsychotics

Disqualifiers: ECOG status 2+, Diabetes, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a 3 month single arm pilot and feasibility study designed to examine the impact of an intermittent fasting lifestyle weight loss intervention on pre-specified clinical milestones (change in body weight, adherence to the fasting program, and moderate-to vigorous physical activity, MVPA) in adults with overweight and obesity and breast cancer after they have completed their cancer treatment. The investigators will also evaluate feasibility of recruitment and retention of study participants, safety of the intervention, and obtain feedback from participants to improve the program. Participants will receive a 3 month lifestyle weight loss program focusing on a 4:3 intermittent fasting paradigm (3 modified fast days per week) and support to increase physical activity to 150 minutes per week. Outcome measures will be assessed at the end of the 3 month intervention (primary endpoint) and after a 3 month weight maintenance follow up phase.

Will I have to stop taking my current medications?

The trial does not require participants to stop taking their current medications. However, you must not be using medications that significantly impact appetite, weight, or energy metabolism, except for anti-endocrine therapy for breast cancer and standard anti-nausea or anti-diarrhea medications.

Is intermittent fasting safe for breast cancer survivors with obesity?

Intermittent fasting has been found to be generally safe for breast cancer patients, potentially reducing chemotherapy side effects like fatigue and nausea. However, more research is needed to confirm these findings and ensure safety for all individuals. ^{1 2 3 4 5}

How is intermittent fasting different from other treatments for breast cancer survivors with obesity?

Intermittent fasting is unique because it involves specific eating patterns, like alternate-day fasting or time-restricted eating, rather than continuous calorie restriction. It may help protect healthy cells and make cancer cells more vulnerable during chemotherapy, potentially reducing side effects and improving quality of life. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Intermittent Fasting for breast cancer survivors with obesity?

Research suggests that intermittent fasting during chemotherapy may help protect healthy cells and make cancer cells more vulnerable, potentially reducing chemotherapy side effects. It may also improve quality of life by reducing fatigue, nausea, and headaches, although the data is considered low quality and further studies are needed. ^{1 2 5 6 7}

Who Is on the Research Team?

Victoria Catenacci, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults who have finished breast cancer treatment, are overweight or obese, and want to try a weight loss program. Participants should be willing to follow an intermittent fasting plan with 3 modified fast days per week and increase physical activity.

Inclusion Criteria

Live or work within 30 miles of the Anschutz Health and Wellness Center (AHWC) (exceptions may be made at the discretion of the Study PI on a case-by- case basis for highly motivated subjects)

Obtain a signed medical clearance from their oncologist for participation in the 4:3 IMF dietary intervention and BfitBwell clinical exercise oncology program. (If participants do not currently have an oncologist signed clearance form their PCP will suffice)

We will recruit participants of all races/ethnicities as the scientific objectives of the study are equally important and valid in all races and ethnicities. In the Denver Metro Area, the population distribution is approximately 73% White, 5% African American, 15% Hispanic, 3% Asian and Pacific Islander, 1% Native American and 3% Other. Although a similar distribution is expected in the proposed study, we will work to ensure adequate minority participation of at least 10% African American and 15% Hispanic

Exclusion Criteria

I have diabetes or high blood sugar, but it's well-controlled if I'm on specific medications.

History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study

Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode or history of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study PI would interfere with ability to participate in the diet and exercise interventions and provide feedback on the interventions via questionnaires and focus groups

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 3-month lifestyle weight loss program focusing on a 4:3 intermittent fasting paradigm and support to increase physical activity

3 months

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for weight maintenance and adherence to lifestyle changes

3 months

Monthly follow-up visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Fasting

Trial Overview The study tests a 16-week weight loss intervention using intermittent fasting (4:3 paradigm) combined with support for increasing exercise to at least 150 minutes weekly. It aims to see how this affects body weight and adherence among participants post-cancer treatment.

How Is the Trial Designed?

Group I: Behavioral Weight Loss Focused on Intermittent Fasting Experimental Treatment 1 Intervention

3-month integrated behavioral weight loss intervention with a dietary focus on intermittent fasting.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Insitutes of Health

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

Intermittent fasting (IF) during chemotherapy for breast cancer patients significantly reduced gastrointestinal toxicity compared to a non-fasting group, suggesting a protective effect of fasting against chemotherapy side effects.

The study, involving 48 HER2-negative breast cancer patients, also indicated that IF improved metabolic profiles, as evidenced by lower insulin levels in the IF group, which may enhance the overall efficacy of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients. Omar, EM., Omran, GA., Mustafa, MF., et al.[2022]

Intermittent fasting (IF) during chemotherapy for breast cancer patients was found to be feasible and safe, potentially alleviating chemotherapy-induced adverse effects like fatigue and nausea, although the quality of the data was low.

While IF showed some promise in reducing chemotherapy-induced DNA damage and improving glycemic regulation, the review did not find significant benefits on quality of life or tumor recurrence, indicating that more rigorous studies are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting in Breast Cancer: A Systematic Review and Critical Update of Available Studies. Anemoulis, M., Vlastos, A., Kachtsidis, V., et al.[2023]

Preliminary findings indicate that combining intermittent fasting or a fasting-mimicking diet with endocrine therapy may enhance the effectiveness of treatment for hormone receptor-positive breast cancer.

This combination approach could also help in reducing side effects associated with the endocrine therapy, suggesting a potential strategy for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting May Complement Endocrine Therapy. [2021]

A pilot study involving 40 women with a history of early-stage breast cancer showed that prolonged overnight fasting (POF) for 13 hours was feasible, with 95% of participants successfully fasting for at least 70% of the study nights.

Participants experienced significant improvements in anxiety, BMI, depression, and fatigue after 12 weeks of fasting, suggesting that POF may be a beneficial nonpharmacological intervention for improving certain health outcomes in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). O'Donnell, E., Shapiro, Y., Comander, A., et al.[2022]

Among 2,741 cancer survivors, 13.8% reported practicing weight-loss restrictive diets, with a higher prevalence in women, those who are overweight/obese, and individuals with breast cancer, indicating a significant trend towards dietary control post-diagnosis.

Fasting was practiced by 6.0% of participants, often associated with the belief that it could improve cancer prognosis; however, those receiving nutritional guidance from healthcare professionals were less likely to engage in fasting or restrictive diets, highlighting the importance of professional dietary advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and weight-loss restrictive diet practices among 2,700 cancer survivors: results from the NutriNet-Santé cohort. Fassier, P., Srour, B., Raynard, B., et al.[2019]

In a study of 32 non-obese individuals over 12 weeks, alternate day fasting (ADF) led to a significant weight loss of 5.2 kg (6.5%) and a reduction in fat mass without affecting fat-free mass, indicating its efficacy for weight management.

ADF also improved cardiovascular risk factors, as evidenced by decreased triacylglycerol levels, increased LDL particle size, and changes in adipokine levels, suggesting potential cardio-protective benefits in normal weight and overweight adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. Varady, KA., Bhutani, S., Klempel, MC., et al.[2021]

In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

Habitual continuous energy restriction (CER) has been shown to effectively prevent breast tumor formation in both animal studies and observational studies in women, while intermittent energy restriction (IER) and intermittent fasting (IF) may offer easier and potentially more effective alternatives for weight control and cancer prevention.

Animal studies suggest that IER and IF can reduce mammary tumor formation and may have different mechanisms of action compared to CER, including greater reductions in fat stores and improved insulin sensitivity, but more research is needed to directly compare these methods in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy restriction and the prevention of breast cancer. Harvie, M., Howell, A.[2013]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Fasting in Breast Cancer: A Systematic Review and Critical Update of Available Studies. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Fasting May Complement Endocrine Therapy. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Fasting and weight-loss restrictive diet practices among 2,700 cancer survivors: results from the NutriNet-Santé cohort. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Energy restriction and the prevention of breast cancer. [2013]