Nutrition and Exercise Program for Cancer Survivors

Overseen By Claudia Schaefer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Appetite suppressants, Antipsychotics, Tricyclics, others

Disqualifiers: Diabetes, Cardiovascular disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you must refrain from using nutritional supplements unless prescribed by a doctor, and certain medications that impact appetite, weight, or energy metabolism are not allowed.

What data supports the effectiveness of the treatment BfedBwell, BfitBwell for cancer survivors?

Research shows that combining exercise and a healthy diet can help cancer survivors maintain muscle mass, reduce body fat, and improve overall health. A study found that a similar nutrition and exercise program led to increased exercise capacity and better health status in cancer survivors, suggesting that BfedBwell, BfitBwell could have similar benefits. ^{1 2 3 4 5}

Is the Nutrition and Exercise Program for Cancer Survivors safe for humans?

Research shows that nutrition and exercise programs for cancer survivors are generally safe and feasible. Studies have found no significant safety concerns, and participants have experienced benefits like improved exercise capacity and health status. ^{1 2 6 7 8}

How does the Nutrition and Exercise Program for Cancer Survivors differ from other treatments for cancer survivors?

This program is unique because it combines diet and exercise interventions specifically adapted for cancer survivors, delivered remotely to improve accessibility. It focuses on personalized, self-management strategies to help survivors maintain muscle mass and improve overall health, which is not typically emphasized in standard cancer treatments. ^{1 2 5 6 9}

What is the purpose of this trial?

This single-arm proof-of-concept pilot will assess the feasibility and acceptability of integrating a survivorship nutrition intervention (BfedBwell) into an existing clinical exercise oncology program (BfitBwell).

Research Team

Emily B Hill, PhD, RDN

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for individuals who are overweight or obese and have survived cancer. It's designed to see if a new nutrition program can work well alongside an existing exercise program made for cancer survivors.

Exclusion Criteria

For intervention participants: Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher, Actively undergoing cancer therapy or within 3 months of completion of surgery, chemotherapy, or radiation treatment, Greater than 5 years post-active therapy, Plans to relocate within the next 6 months, Plans for extended travel (>2 weeks) within the next 6 months, For females: Currently pregnant or lactating, Pregnant within the past 6 months, Planning to become pregnant in the next 18 months; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception, Any major surgery within the past 3 months, including mastectomy, Have completed treatment that significantly impacts digestion, metabolism, and/or food intake (e.g., surgical loss of esophagus, stomach, colon), Recent (past 6 months) acute coronary event, unstable angina, coronary revascularization, stroke, or pulmonary embolism, Symptoms suggestive of cardiovascular disease (e.g., chest pain, shortness of breath at rest or with mild exertion, lightheadedness, syncope), Uncontrolled hypertension, defined as diastolic blood pressure >100 mmHg, systolic blood pressure >160 mmHg, or resting heart rate >100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position (if screening is needed due to lack of updated medical record within previous 12 months), Diabetes (history of type 1 or type 2 diabetes, hemoglobin A1c >7.5%, or fasting glucose ≥126 mg/dL as measured during the screening visit if screening is needed due to lack of updated medical record within previous 12 months) unless well controlled on metformin alone, History of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen is acceptable, Triglycerides >500 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months), LDL cholesterol >200 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months), Presence or history of other metabolic or chronic health problems which would impact ability to safely participate in a weight loss intervention involving diet and exercise: significant cardiac arrhythmias or cardiac valvular disease, significant gastrointestinal, pulmonary, renal, musculoskeletal, neurologic, hematologic, or psychiatric disease, Have started lipid-lowering, hypertension, or oral hypoglycemic medication in previous 3 months, Sustained use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., obesity pharmacotherapeutics agents, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) with the exception of anti-endocrine or Her2 directed treatment for breast cancer and standard of care anti-emetic or anti-diarrheal agents, Sustained use of systemic glucocorticoids (current or in the past 6 months) unless physiologic replacement therapy for adrenal insufficiency, Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed >1 year before screening, (2) lap banding if the band has been removed >1 year before screening, (3) intragastric balloon if the balloon has been removed >1 year before screening, (4) duodenal-jejunal bypass sleeve if the sleeve has been removed >1 year before screening, or (5) AspireAssist or other endoscopically placed weight loss device if the device has been removed >1 year before screening, Participation within previous 6 months, current participation in, or planning to participate in any formal nutrition, weight loss, or physical activity programs or clinical trials over the next 6 months, Previous participation the BfitBwell exercise oncology program, Current alcohol or substance abuse as assessed by the Cut down, Annoyed, Guilty, and Eye-Opener (CAGE) questionnaire (note: study PI will follow up if screener raises any concerns of substance abuse to determine final eligibility), 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 Center for Epidemiologic Studies Depression Scale (CES-D), History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the study MD would interfere with ability to adhere to the diet and exercise interventions, Have medical or physical limitations or contraindications to engaging in physical activity (e.g., severe orthopedic conditions, paralysis) or are considered high-risk based on ACSM guidelines, Are cognitively unable to consent

For program delivery staff: None

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week integrated BfedBwell + BfitBwell intervention, including group nutrition education, skills development sessions, cooking demonstrations, and 1:1 counseling with a dietitian.

12 weeks

Follow-up

Participants are monitored for adherence to cancer survivorship guidelines, body composition, and cardiometabolic health indicators.

4 weeks

Treatment Details

Interventions

• BfedBwell
• BfitBwell

Trial Overview The study is testing the integration of 'BfedBwell', which includes group-based nutritional education, cooking demos, and individual counseling, into the 'BfitBwell' clinical exercise program for cancer survivors.

Participant Groups

Group I: Cancer Survivors Experimental Treatment 4 Interventions

Cancer survivors with ow/ob who have completed active treatment will take part in a single-arm 12-week feasibility/acceptability/proof-of-concept study incorporating group nutrition education and discussion, skills development sessions and cooking demonstrations, and 1:1 counseling with a dietitian.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

The simultaneous stage-matched exercise and diet (SSED) intervention was found to be feasible and well-accepted among 45 breast cancer survivors, with 91% completing the trial and 100% receiving intervention calls.

Participants in the SSED group showed significant improvements in motivational readiness for exercise and diet, as well as better emotional functioning, reduced fatigue, and lower depression compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. Kim, SH., Shin, MS., Lee, HS., et al.[2022]

The Flinders Living Well Self-Management Program™ (FLW Program) is a feasible and acceptable intervention for Australian cancer survivors, showing promise in maintaining muscle mass and improving exercise capacity during and after treatment.

Participants in the program experienced small but positive changes in body composition and significant improvements in global health status, particularly in those who were post-treatment, suggesting that early implementation during chemotherapy could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Self-Management-based Nutrition and Physical Activity Intervention in Cancer Survivors. Miller, M., Zrim, S., Lawn, S., et al.[2018]

A 6-month individualized nutrition intervention for breast cancer patients led to significant reductions in body weight (3.1 kg) and fat mass (2.7 kg), while preserving muscle mass during treatment.

The program, which included tailored dietary plans and regular follow-ups, helped participants make healthier food choices and effectively reduced abdominal and visceral fat without negatively impacting bone density or muscle mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An individualized food-based nutrition intervention reduces visceral and total body fat while preserving skeletal muscle mass in breast cancer patients under antineoplastic treatment. Limon-Miro, AT., Valencia, ME., Lopez-Teros, V., et al.[2021]

Interventions promoting exercise and healthy body weight are increasingly recognized as important for improving the long-term health of cancer survivors, addressing issues like obesity and physical inactivity.

The review highlights differences in research and clinical priorities between Europe and North America regarding energy balance interventions, suggesting a need for international collaboration to enhance care and outcomes for post-treatment cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to promote energy balance and cancer survivorship: priorities for research and care. Alfano, CM., Molfino, A., Muscaritoli, M.[2023]

The AMPLIFI study is testing web-based diet and exercise interventions for middle-aged and older cancer survivors, focusing on improving health behaviors and reducing obesity-related risks through three randomized controlled trials involving multiple behavior change strategies.

The study will assess the efficacy of sequential versus simultaneous interventions over a 2-year period, measuring various health outcomes such as body mass index, physical activity, and muscle mass, using remote technologies for recruitment and assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. Pekmezi, D., Fontaine, K., Rogers, LQ., et al.[2023]

References

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

Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. [2022]

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

A Pilot Study of Self-Management-based Nutrition and Physical Activity Intervention in Cancer Survivors. [2018]

3. England pubmed.ncbi.nlm.nih.gov

An individualized food-based nutrition intervention reduces visceral and total body fat while preserving skeletal muscle mass in breast cancer patients under antineoplastic treatment. [2021]

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

Interventions to promote energy balance and cancer survivorship: priorities for research and care. [2023]

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

Care of Cancer Survivors: Nutrition and Physical Activity. [2023]

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

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. [2023]

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

Recommendations for Obesity Clinical Trials in Cancer Survivors: American Society of Clinical Oncology Statement. [2017]

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

Physical activity preferences among a population-based sample of colorectal cancer survivors. [2013]

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

Self-Reported Changes and Perceived Barriers to Healthy Eating and Physical Activity among Global Breast Cancer Survivors: Results from an Exploratory Online Novel Survey. [2022]