The Impact of Functional Medicine On Wound Healing From Delayed Autologous Breast Reconstruction

NCT ID: NCT05028101

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-06-06

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.

Conditions

Breast Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control (Standard of Care (SOC))

Reconstructive surgical technique, delayed autologous breast reconstruction, and usual local anesthesia and analgesia during hospital stay.

Group Type: ACTIVE_COMPARATOR

Delayed autologous breast reconstruction

Intervention Type: PROCEDURE

SOC: Delayed autologous breast reconstruction

SOC + Functional Medicine

Reconstructive 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.

Group Type: EXPERIMENTAL

Delayed autologous breast reconstruction

Intervention Type: PROCEDURE

SOC: Delayed autologous breast reconstruction

Perioperative Functional Medicine (FM) Care

Intervention Type: BEHAVIORAL

SOC plus FM: A food plan that encourages consumption of nutrient-dense whole foods. It provides adequate protein, balanced quality fats and foods which contain targeted nutrients essential to proper wound healing. Select dietary supplements will be provided as an adjunct to the food plan. Health coaching will support optimal sleep, adequate movement/exercise and stress reduction.

Interventions

Delayed autologous breast reconstruction

SOC: Delayed autologous breast reconstruction

Intervention Type: PROCEDURE

Perioperative Functional Medicine (FM) Care

SOC plus FM: A food plan that encourages consumption of nutrient-dense whole foods. It provides adequate protein, balanced quality fats and foods which contain targeted nutrients essential to proper wound healing. Select dietary supplements will be provided as an adjunct to the food plan. Health coaching will support optimal sleep, adequate movement/exercise and stress reduction.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Shallcross, ND, MPH

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE4119

Identifier Type: -

Identifier Source: org_study_id