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

NCT05028101 | Terminated

• 1 other identifier: CASE4119
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (8)

• Feasibility defined by percent randomized.

  Success will be defined as enrolling and randomizing 25% or more of those screened per arm.

  Baseline

• Number of in-person visits completed.

  Number of in-person visits completed.

  Up to 26 weeks

• Number of virtual visits completed.

  Number of virtual visits completed.

  Up to 26 weeks

• Adherence to recommended dietary intervention.

  Percent of participants adhering to recommended dietary intervention.

  Up to 26 weeks

• Adherence to recommended lifestyle interventions.

  Percent of participants adhering to lifestyle interventions.

  Up to 26 weeks

• Adherence to prescribed dietary supplementation.

  Percent of participants adhering to prescribed dietary supplementation.

  Up to 26 weeks

• Percent completion of study-specific surveys.

  Percent of the following surveys completed: * BreastQ (baseline, wks 12, and 26) * PROMIS Questionnaire (baseline and wks 5, 12 and 26) * Medical Symptom Questionnaire (MSQ) (baseline and wks 5, 12 and 26) * Nutrition and Lifestyle Adherence Survey (randomization and then weekly for the duration of the study) * Dietary Supplementation Adherence Survey (only those randomized to SOC plus functional medicine; wk1 and then weekly for the duration of the study) Note: the BRA and SKIN surveys are not completed by the patient, but by the provider.

  Up to 26 weeks

• Number of Serious Adverse Events (SAE's).

  Number of Serious Adverse Events (SAE's).

  Up to 26 weeks

Secondary Outcomes (71)

• Number of re-operations for wound management.

  Up to 26 weeks

• Number of hospital re-admissions.

  Up to 26 weeks

• Length-of-stay upon hospital re-admission.

  Up to 26 weeks

• Number of antibiotic prescriptions.

  Up to 26 weeks

• Correlate all post-operative complications with the predicted risk from the BRA scoring system.

  Up to 26 weeks

Study Arms (2)

Control (Standard of Care (SOC))

ACTIVE COMPARATOR

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

Procedure: Delayed autologous breast reconstruction

SOC + Functional Medicine

EXPERIMENTAL

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.

Procedure: Delayed autologous breast reconstruction; Behavioral: Perioperative Functional Medicine (FM) Care

Interventions

Delayed autologous breast reconstruction PROCEDURE

SOC: Delayed autologous breast reconstruction

Control (Standard of Care (SOC)); SOC + Functional Medicine

Perioperative Functional Medicine (FM) Care 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.

SOC + Functional Medicine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Amanda Shallcross, ND, MPH

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: August 31, 2021
• Study Start: February 20, 2023
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)