Back to results

Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy

Primary Purpose

Tumor Surgery

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Caloric Restriction Diet

About this trial

This is an interventional supportive care trial for Tumor Surgery focused on measuring Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age >18 years
Biopsy proven soft tissue sarcoma located in the extremities
Patient to be treated with radiation therapy for a primary extremity soft tissue sarcoma or recurrent tumor after surgery, followed by surgical resection
Karnofsky Score ≥ 60%
Body Mass Index (BMI) ≥ 20 kg/m2
Albumin and pre-albumin levels within normal limits

Exclusion Criteria:

Current pregnancy and breast feeding
Other cancers diagnosed within the last 5 years (in situ and/or invasive)
Diabetes mellitus
Current metformin therapy
Other conditions may exclude participants from the study (e.g. intractable nausea/emesis)

Sites / Locations

Massachusetts general Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Caloric Restriction Diet

Normal Diet

Arm Description

Patients will meet with the Registered Dietitian to discuss calorie, protein and fluid needs.The dietitian will calculate calorie needs. Calorie needs will then be reduced to 30%. Protein needs will be estimated based on 0.8g/kg BW and then reduced by 70%. Dietitian will educate participants on electrolytes and fluid intake based on the reduced food intake.

Participant will follow a normal diet.

Outcomes

Primary Outcome Measures

Change In The Rate Of Physical Function

Musculoskeletal Tumor Society Rating Scale (MSTS, a clinician-rated scale scoring)

Change In The Rate Of Physical Function

Toronto Extremity Salvage Score (TESS, a patient reported questionnaire scoring

Secondary Outcome Measures

The Rate Of Wound Healing

The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group

Full Information

NCT ID

NCT02792270

First Posted

May 16, 2016

Last Updated

June 1, 2016

Sponsor

Massachusetts General Hospital

Collaborators

NORCH (Nutrition Obesity Research Center at Harvard)

1. Study Identification

Unique Protocol Identification Number

NCT02792270

Brief Title

Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy

Official Title

Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

NORCH (Nutrition Obesity Research Center at Harvard)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is being conducted to decrease the rate of surgical wound complications. The investigators are studying the effects that caloric restriction has on decreasing the rate of surgical wound complications.

Detailed Description

The goal is to decrease the chance of having wound complications after surgery. Caloric Restriction has been found to be a natural modifier of surgical outcomes. Participants will be randomize into the arms Caloric Restriction Diet or Normal Diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tumor Surgery

Keywords

Surgery

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Caloric Restriction Diet

Arm Type

Experimental

Arm Description

Arm Title

Normal Diet

Arm Type

No Intervention

Arm Description

Participant will follow a normal diet.

Intervention Type

Other

Intervention Name(s)

Caloric Restriction Diet

Intervention Description

A nutritional supplement called Scandishake (Nutridrinks, Perivale, UK) will be used for 3 days before surgery. - Scandishake will be mixed with 8 oz of whole fat cow milk, whole fat lactaid milk, almond milk or soy milk. The proposed macronutrient profile for the 3 days of caloric restriction (CR) is: 45% fat, 46% carbohydrate, and 8% protein.

Primary Outcome Measure Information:

Title

Change In The Rate Of Physical Function

Description

Musculoskeletal Tumor Society Rating Scale (MSTS, a clinician-rated scale scoring)

Time Frame

Baseline, 6 weeks, 3 months and 6 months visits after surgery

Title

Change In The Rate Of Physical Function

Description

Toronto Extremity Salvage Score (TESS, a patient reported questionnaire scoring

Time Frame

Baseline, 6 weeks, 3 months and 6 months visits after surgery

Secondary Outcome Measure Information:

Title

The Rate Of Wound Healing

Time Frame

2 years

Title

The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >18 years Biopsy proven soft tissue sarcoma located in the extremities Patient to be treated with radiation therapy for a primary extremity soft tissue sarcoma or recurrent tumor after surgery, followed by surgical resection Karnofsky Score ≥ 60% Body Mass Index (BMI) ≥ 20 kg/m2 Albumin and pre-albumin levels within normal limits Exclusion Criteria: Current pregnancy and breast feeding Other cancers diagnosed within the last 5 years (in situ and/or invasive) Diabetes mellitus Current metformin therapy Other conditions may exclude participants from the study (e.g. intractable nausea/emesis)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karen De Amorin Bernstein, MD

Phone

617-726-6876

kbernstein@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen De Amorin Bernstein, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts general Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen De Amorin Bernstein, MD

Phone

617-726-6876

kbernstein@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Karen De Amorin Bernstein, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy

We'll reach out to this number within 24 hrs