Clinical trial NCT05028101: The Impact of Functional Medicine On Wound Healing From Delayed Autologous Breast Reconstruction
Official title: The Impact of Functional Medicine On Wound Healing From Delayed Autologous Breast Reconstruction - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Reconstruction
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will examine if a functional medicine approach, delivered as an adjunct to standard of care, is feasible, safe, clinically beneficial and cost-effective for patients undergoing autologous breast reconstruction.

Detailed description: Autologous microsurgical breast reconstruction is associated with a protracted recovery and a significant amount of opioid utilization. Many institutions have "Enhanced Recovery After Surgery (ERAS)" protocols that utilize multi-modality therapy to decrease opioid use, length of stay, hospital costs and expedite recovery. However, nutrition-based interventions used perioperatively are not currently part of ERAS protocols for surgical sub-specialties, including breast surgery despite ample literature that nutrition (with or without supplements) can improve surgical wound healing and other outcomes.

The functional medicine model of care expands upon the conventional medicine model of care by providing a unique operating system that works to reverse illness, promote health and optimize function. A foundation of functional medicine is the use of food as medicine to prevent, treat and reverse chronic disease. Dietary supplements are used as an adjunct to nutrition-based interventions. Dietitians support patients with implementing food plans, and health coaches support patients through lifestyle and behavioral changes focused on sleep, exercise and movement and stress reduction.

This study will examine the feasibility of implementing a functional medicine-based intervention focused on nutrition and lifestyle, and the ability of the intervention to improve wound healing and decrease various post-operative complications in patients undergoing autologous breast reconstruction.

All participants will be asked to attend study visits, complete questionnaires and have their blood drawn. Participants randomized to standard of care plus functional medicine will be asked to also follow a specific food plan, take specific dietary supplements, exercise and engage in stress reduction techniques for 3 months prior to and after surgery. The study duration is 6 months.

Eligibility criteria: Inclusion Criteria:

* Undergoing uni- or bilateral delayed abdominally-based breast reconstruction at the Cleveland Clinic.
* 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.
* Willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

* BMI \> 37
* Women who are pregnant, nursing, or planning pregnancy during the trial.
* Have a serious concomitant illness that could interfere with the subject's participation in the trial (allergy preventing supplement usage)
* Undergoing chemotherapy during proposed nutritional intervention (3 months before or after surgery).
* Are unable to or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
* Clinical diagnosis of cognitive impairment or dementia.
* Known sensitivity to nutritional supplements.
* History of being seen or had intervention/care in Functional Medicine or following Functional Medicine principles.

Primary outcomes:
measure: Feasibility defined by percent randomized.
timeFrame: Baseline
measure: Number of in-person visits completed.
timeFrame: Up to 26 weeks
measure: Number of virtual visits completed.
timeFrame: Up to 26 weeks
measure: Adherence to recommended dietary intervention.
timeFrame: Up to 26 weeks
measure: Adherence to recommended lifestyle interventions.
timeFrame: Up to 26 weeks
measure: Adherence to prescribed dietary supplementation.
timeFrame: Up to 26 weeks
measure: Percent completion of study-specific surveys.
timeFrame: Up to 26 weeks
measure: Number of Serious Adverse Events (SAE's).
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: Number of re-operations for wound management.
timeFrame: Up to 26 weeks
measure: Number of hospital re-admissions.
timeFrame: Up to 26 weeks
measure: Length-of-stay upon hospital re-admission.
timeFrame: Up to 26 weeks
measure: Number of antibiotic prescriptions.
timeFrame: Up to 26 weeks
measure: Correlate all post-operative complications with the predicted risk from the BRA scoring system.
timeFrame: Up to 26 weeks
measure: Correlate post-operative surgical site infection complications with the predicted risk from the BRA scoring system.
timeFrame: Up to 26 weeks
measure: Correlate post-operative seroma complications with the predicted risk from the BRA scoring system.
timeFrame: Up to 26 weeks
measure: Correlate post-operative dehiscence complications with the predicted risk from the BRA scoring system.
timeFrame: Up to 26 weeks
measure: Correlate post-operative flap loss complications with the predicted risk from the BRA scoring system.
timeFrame: Up to 26 weeks
measure: Correlate post-operative reoperation complications with the predicted risk from the BRA scoring system.
timeFrame: Up to 26 weeks
measure: Evaluate narcotic utilization while in the hospital.
timeFrame: While in hospital, an average of 3 days
measure: Evaluate narcotic utilization while in the hospital.
timeFrame: While in hospital, an average of 3 days
measure: Evaluate narcotic utilization while in the hospital.
timeFrame: While in hospital, an average of 3 days
measure: Evaluate narcotic utilization while in the hospital.
timeFrame: While in hospital, an average of 3 days
measure: Evaluate narcotic utilization while in the hospital.
timeFrame: While in hospital, an average of 3 days
measure: Evaluate narcotic utilization while in the hospital.
timeFrame: While in hospital, an average of 3 days
measure: Evaluate narcotic utilization while in the hospital.
timeFrame: While in hospital, an average of 3 days
measure: Evaluate narcotic utilization while in the hospital.
timeFrame: While in hospital, an average of 3 days
measure: Evaluate narcotic utilization while in the hospital.
timeFrame: While in hospital, an average of 3 days
measure: Change in Complete Blood Count with Differential (CBC).
timeFrame: Baseline to 12 weeks
measure: Change in Complete Blood Count with Differential (CBC).
timeFrame: Baseline to 26 weeks
measure: Change in Comprehensive Metabolic Pane (CMP).
timeFrame: Baseline to 12 weeks
measure: Change in Comprehensive Metabolic Pane (CMP).
timeFrame: Baseline to 26 weeks
measure: Change in Hemoglobin A1c (HbA1c).
timeFrame: Baseline to 12 weeks
measure: Change in Hemoglobin A1c (HbA1c).
timeFrame: Baseline to 26 weeks
measure: Change in nuclear magnetic resonance (NMR) LipoProfile.
timeFrame: Baseline to 12 weeks
measure: Change in NMR LipoProfile.
timeFrame: Baseline to 26 weeks
measure: Change in high-sensitivity C-Reactive Protein (hsCRP).
timeFrame: Baseline to 12 weeks
measure: Change in high-sensitivity C-Reactive Protein (hsCRP).
timeFrame: Baseline to 26 weeks
measure: Change in Vitamin D.
timeFrame: Baseline to 12 weeks
measure: Change in Vitamin D.
timeFrame: Baseline to 26 weeks
measure: Change in OmegaCheck.
timeFrame: Baseline to 12 weeks
measure: Change in OmegaCheck.
timeFrame: Baseline to 26 weeks
measure: Total healthcare costs.
timeFrame: At 26 weeks
measure: Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
timeFrame: Baseline to week 12
measure: Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
timeFrame: Baseline to week 26
measure: Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
timeFrame: Baseline to week 5
measure: Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
timeFrame: Baseline to week 5
measure: Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
timeFrame: Baseline to week 12
measure: Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) scores.
timeFrame: Baseline to week 26
measure: Change in mean value of the continuous variable of PROMIS GPH.
timeFrame: Baseline to week 5
measure: Change in mean value of the continuous variable of PROMIS GPH.
timeFrame: Baseline to week 12
measure: Change in mean value of the continuous variable of PROMIS GPH.
timeFrame: Baseline to week 26
measure: Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH).
timeFrame: Baseline to week 5
measure: Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH).
timeFrame: Baseline to week 12
measure: Net change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH).
timeFrame: Baseline to week 26
measure: Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH) scores.
timeFrame: Baseline to week 5
measure: Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH) scores.
timeFrame: Baseline to week 12
measure: Clinically-meaningful change in Patient-Reported Outcome Measurement Information System (PROMIS) Global Mental Health (GMH) scores.
timeFrame: Baseline to week 26
measure: Change in mean value of the continuous variable of PROMIS GMH.
timeFrame: Baseline to week 5
measure: Change in mean value of the continuous variable of PROMIS GMH.
timeFrame: Baseline to week 12
measure: Change in mean value of the continuous variable of PROMIS GMH.
timeFrame: Baseline to week 26
measure: Change in Breast-Q scores.
timeFrame: Baseline to week 12
measure: Change in Breast-Q scores.
timeFrame: Baseline to week 26
measure: Change in Medical System Questionnaire (MSQ) scores.
timeFrame: Baseline to week 5
measure: Change in Medical System Questionnaire (MSQ) scores.
timeFrame: Baseline to week 12
measure: Change in Medical System Questionnaire (MSQ) scores.
timeFrame: Baseline to week 26
measure: Change in Nutrition and Lifestyle Adherence Survey scores.
timeFrame: Baseline to week 12
measure: Change in Nutrition and Lifestyle Adherence Survey scores.
timeFrame: Baseline to week 26
measure: Change in Dietary Supplement Adherence Survey scores.
timeFrame: Baseline to week 12
measure: Change in Dietary Supplement Adherence Survey scores
timeFrame: Baseline to week 26
measure: Number of days wounds necessitate dressing changes or packing post-surgery.
timeFrame: At 26 weeks
measure: SKIN Survey composite scores.
timeFrame: At 14 weeks
measure: SKIN Survey composite scores.
timeFrame: At 15 weeks
measure: SKIN Survey composite scores.
timeFrame: At 17 weeks
measure: Average incision length.
timeFrame: At 14 weeks
measure: Average incision length.
timeFrame: At 15 weeks
measure: Average incision length.
timeFrame: At 17 weeks
measure: Average dehiscence length.
timeFrame: At 14 weeks
measure: Average dehiscence length.
timeFrame: At 15 weeks
measure: Average dehiscence length.
timeFrame: At 17 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Amanda Shallcross, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References: