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Functional Medicine for Breast Reconstruction Healing

N/A

Recruiting

Led By Amanda Shallcross, ND, MPH

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing uni- or bilateral delayed abdominally-based breast reconstruction at the Cleveland Clinic

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 26 weeks

Awards & highlights

Study Summary

This trial will test if a functional medicine approach can help improve outcomes and lower costs for patients undergoing breast reconstruction surgery.

Who is the study for?

This trial is for women undergoing delayed breast reconstruction who can use birth control and give written consent. It's not for those pregnant, nursing, or planning pregnancy; on chemotherapy near surgery time; with cognitive issues; already following Functional Medicine; in a diet program; using recent investigational drugs; with serious illnesses or allergies to supplements; or who had prior radiation to the breast.Check my eligibility

What is being tested?

The study tests if adding Functional Medicine care to standard treatment helps wound healing after autologous breast reconstruction. Participants will receive this extra care around their surgery time and researchers will check if it's safe, helpful, and cost-effective.See study design

What are the potential side effects?

Since the intervention includes nutritional supplements and lifestyle changes rather than medications, side effects may be minimal but could include reactions to supplements for those with sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having breast reconstruction with abdominal tissue at the Cleveland Clinic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to prescribed dietary supplementation.

Adherence to recommended dietary intervention.

Adherence to recommended lifestyle interventions.

+5 more

Secondary outcome measures

Average dehiscence length.

Average incision length.

Change in Breast-Q scores.

+32 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SOC + Functional MedicineExperimental Treatment2 Interventions

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 II: Control (Standard of Care (SOC))Active Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,890 Total Patients Enrolled

3 Trials studying Breast Reconstruction

63 Patients Enrolled for Breast Reconstruction

Amanda Shallcross, ND, MPHPrincipal InvestigatorThe Cleveland Clinic

1 Previous Clinical Trials

27 Total Patients Enrolled

Michelle Beidelschies, PhDPrincipal InvestigatorCenter for Functional Medicine, Cleveland Clinic

Media Library

Delayed Autologous Breast Reconstruction Clinical Trial Eligibility Overview. Trial Name: NCT05028101 — N/A

Breast Reconstruction Research Study Groups: Control (Standard of Care (SOC)), SOC + Functional Medicine

Breast Reconstruction Clinical Trial 2023: Delayed Autologous Breast Reconstruction Highlights & Side Effects. Trial Name: NCT05028101 — N/A

Delayed Autologous Breast Reconstruction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05028101 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants enrolled in this experiment?

"Affirmative; the relevant information hosted on clinicaltrials.gov indicates that candidates are being sought for this medical trial, which was first posted on November 1st 2021 and recently updated on November 8th 2022. The study is hoping to enrol 20 patients from a single site."

Answered by AI

Are there any available opportunities for people to join this experiment?

"As showcased on clinicaltrials.gov, this medical study is actively recruiting participants. It was first publicized on November 1st 2021 and had its most recent update take place on the 8th of November 2022."

Answered by AI

What outcome is this experiment designed to uncover?

"The primary outcome of this medical trial, measuring over a period not exceeding 26 weeks, is to monitor adherence to recommended lifestyle interventions. Secondary outcomes include changes in Medical System Questionnaire (MSQ) scores - the MSQ assesses symptoms exhibited by patients within 48 hours and uses semantic differential scales to determine frequency and gauge progress; higher scores indicate more severe symptoms while lower numbers suggest improvement. Additional measures are average incision length for wound healing and change in mean value of PROMIS GMH's continuous variable."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "The Impact of Functional Medicine On Wound Healing From Delayed Autologous Breast Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05028101.