Perioperative Functional Medicine (FM) Care for Breast Reconstruction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic, Cleveland, OH
Breast Reconstruction
Perioperative Functional Medicine (FM) Care - Behavioral
Eligibility
18+
Female
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Study Summary

This study is evaluating whether a functional medicine approach is safe and effective for women undergoing autologous breast reconstruction.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Reconstruction

Study Objectives

This trial is evaluating whether Perioperative Functional Medicine (FM) Care will improve 8 primary outcomes and 35 secondary outcomes in patients with Breast Reconstruction. Measurement will happen over the course of While in hospital, an average of 3 days.

At 17 weeks
Average dehiscence length.
Average incision length.
SKIN Survey composite scores.
At 26 weeks
Number of days wounds necessitate dressing changes or packing post-surgery.
Total healthcare costs.
Baseline
Feasibility defined by percent randomized.
Baseline to 12 weeks
Change in nuclear magnetic resonance (NMR) LipoProfile.
Baseline to 26 weeks
Change in Complete Blood Count with Differential (CBC).
Change in Comprehensive Metabolic Pane (CMP).
Change in Hemoglobin A1c (HbA1c).
Change in NMR LipoProfile.
Change in OmegaCheck.
Change in Vitamin D.
Change in high-sensitivity C-Reactive Protein (hsCRP).
Baseline to week 12
Change in Dietary Supplement Adherence Survey scores.
Baseline to week 26
Change in Breast-Q scores.
Change in Dietary Supplement Adherence Survey scores
Change in Medical System Questionnaire (MSQ) scores.
Change in Nutrition and Lifestyle Adherence Survey scores.
Change in mean value of the continuous variable of PROMIS GMH.
Change in mean value of the continuous variable of PROMIS GPH.
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH) scores.
Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH).
Baseline to week 5
Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
Up to 26 weeks
Adherence to prescribed dietary supplementation.
Adherence to recommended dietary intervention.
Adherence to recommended lifestyle interventions.
Correlate all post-operative complications with the predicted risk from the BRA scoring system.
Correlate post-operative dehiscence complications with the predicted risk from the BRA scoring system.
Correlate post-operative flap loss complications with the predicted risk from the BRA scoring system.
Correlate post-operative reoperation complications with the predicted risk from the BRA scoring system.
Correlate post-operative seroma complications with the predicted risk from the BRA scoring system.
Correlate post-operative surgical site infection complications with the predicted risk from the BRA scoring system.
Length-of-stay upon hospital re-admission.
Number of Serious Adverse Events (SAE's).
Number of antibiotic prescriptions.
Number of hospital re-admissions.
Number of in-person visits completed.
Number of re-operations for wound management.
Number of virtual visits completed.
Percent completion of study-specific surveys.
Day 3
Evaluate narcotic utilization while in the hospital.

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Reconstruction

Trial Design

2 Treatment Groups

Control (Standard of Care (SOC))
1 of 2
SOC + Functional Medicine
1 of 2
Active Control
Experimental Treatment

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Perioperative Functional Medicine (FM) Care is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

SOC + Functional MedicineReconstructive surgical technique, delayed autologous breast reconstruction, and usual local anesthesia and analgesia during hospital stay. Perioperative nutrition and lifestyle-based interventions along with select dietary supplements.
Control (Standard of Care (SOC))
Procedure
Reconstructive surgical technique, delayed autologous breast reconstruction, and usual local anesthesia and analgesia during hospital stay.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 26 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 26 weeks for reporting.

Closest Location

Cleveland Clinic - Cleveland, OH

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study.
Capable of providing written informed consent prior to any protocol-specified procedures.
Undergoing uni- or bilateral delayed abdominally-based breast reconstruction at the Cleveland Clinic.
Willing to adhere to the study visit schedule and other protocol requirements.

Patient Q&A Section

What are common treatments for breast reconstruction?

"Patients with breast conserving surgery are candidates for breast reconstructive surgery. When breast conserving surgery is not possible or appropriate, mastectomy and DI are [common treatments for reconstruction from breast tissue samples] (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3254924/)." - Anonymous Online Contributor

Unverified Answer

What causes breast reconstruction?

"There are several significant reasons for choosing a breast reconstruction procedure over other options, including improving the aesthetic appearance of the breast, alleviating psychological discomfort and social isolation, and achieving a stable and more satisfactory bodily appearance that would prevent re-plastic surgery. More studies are needed for a better understanding of the complex etiology of the reconstructive choice." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast reconstruction?

"The signs that are indicative of BTR are the pain, sensation of “bowing” of the ribs, and the tightening of the scar. Breast enlargement can lead to both positive and negative physical symptoms. These symptoms should not be underestimated and can be minimized by choosing a technique that meets a patient's individual needs.\n" - Anonymous Online Contributor

Unverified Answer

Can breast reconstruction be cured?

"Despite improvements in breast reconstruction technique, complication rates remain high. Breast reconstruction continues to be a challenging but necessary and life-changing procedure for women undergoing breast surgery." - Anonymous Online Contributor

Unverified Answer

How many people get breast reconstruction a year in the United States?

"Approximately 5,000 breast reconstructions were performed a year in 2005. During this period, 1,200 women were diagnosed with invasive carcinoma. The five-year survival rate following reconstruction was high, and the rate of complications was low. In order of frequency, complications were axillary lymphadenopathy and lymphoedema. The most common reconstructive operation performed was mastectomy with breast preservation." - Anonymous Online Contributor

Unverified Answer

What is breast reconstruction?

"Breast reconstruction by breast enhancement represents both aesthetic and functional reconstruction of the reconstructive patient. Reconstructive surgical technique and preoperative expectations of the patient will strongly influence her or his expectations and perceptions of the outcome." - Anonymous Online Contributor

Unverified Answer

How serious can breast reconstruction be?

"The most severe complication of breast reconstruction was seroma. The lowest incidence of seroma was in the subcutaneous approach to breast reconstruction. However, the high occurrence of necrosis and contracture at the donor-site is the greatest concern." - Anonymous Online Contributor

Unverified Answer

Is perioperative functional medicine (fm) care typically used in combination with any other treatments?

"Fm is not routinely practiced in breast reconstruction. The most common combination appears to be perioperative and postoperative physical therapy in addition to some other treatment, including a combination of fm, fm/medical (i.e., conventional, nonfm medication), and fm/chirotherapy (i.e., chiropractic, physiotherapy, yoga or osteopathic manipulative), which may also include medications or more complex noninvasive procedures, such as tibial osteotomy, osteotomy or arthrodesis treatment." - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast reconstruction?

"With the ever-growing number of women seeking breast reconstruction, the field of breast reconstruction is shifting toward the use of micro-sutures and free flaps in order to maximize aesthetic results. These procedures can be performed by a wide variety of plastic surgeons. There are no longer any significant differences in results between these two procedures, but some plastic surgeons still prefer a periareolar breast reconstruction. The reasons for this discrepancy include a preference for an implant-based procedure, aesthetics, and low complication rates. In this article, we look at the most recent plastic surgery procedures involving breast reconstruction. If you have questions or need some more information on an upcoming procedure, then go to [Power(https://www.withpower." - Anonymous Online Contributor

Unverified Answer

Has perioperative functional medicine (fm) care proven to be more effective than a placebo?

"Perioperative fm care has not been proven to be more effective than a placebo in this cohort of breast reconstruction patients. The findings suggest that the fm intervention may be used and is a sensible addition to standard postoperative care." - Anonymous Online Contributor

Unverified Answer

What does perioperative functional medicine (fm) care usually treat?

"While the goal of any intervention is to achieve maximum functional recovery, we emphasize that the patient needs to be an individual person with an individualized plan when considering functional outcomes. Therefore, the patient needs to be fully engaged in the decision-making process, with the expectation of achieving an individualized plan of action to maximize functional performance." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for breast reconstruction?

"At this time the authors' recommendation is not to participate in clinical trials when contemplating the repair of a large, or extensive, breast cancer defect, regardless of the method for reconstruction. However, clinical trials are an option for patients who are considering one or more alternative methods for reconstruction." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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