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Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT

ConditionTumor Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Biopsy proven soft tissue sarcoma located in the lower extremities

Patient to be treated with radiation therapy for a primary lower extremity soft tissue sarcoma or recurrent tumor after surgery, followed by surgical resection

Karnofsky Score ≥ 60%

Disqualifiers

Current pregnancy and breast feeding

Other cancers diagnosed within the last 5 years (in situ and/or invasive)

Diabetes mellitus

Current metformin therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Caloric Restriction Diet

    Other intervention

    Two nutritional supplements, one from Ensure (Abbott Laboratories, Chicago, IL) and one from Boost (Nestle, Vevey, Switzerland) will be used for 3 days before surgery. The supplements are the Ensure Pre-Surgery Clear Carbohydrate Drink and the Ensure Original Nutrition Powder. The Original Nutrition Powder will be mixed with 8oz of water, oat milk, or almond milk. The proposed macronutrient profile for the 3 days of caloric restriction (CR) is less than 8% of calories from protein.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Caloric Restriction DietExperimental treatment 1 intervention
Group B: Normal DietNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change In The Rate Of Physical Function By MSTS

The Musculoskeletal Tumor Society Rating Scale (MSTS) is a clinician-based scoring system that is scored out of 35 points. A higher score indicates better physical function.

Time frame
Baseline, 6 weeks, 3 months and 6 months visits after surgery
2

Change In The Rate Of Physical Function By TESS

The Toronto Extremity Salvage Score (TESS) is a patient-reported scoring system that is scored out of 100 points. A higher score indicates better physical function.

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

Secondary outcomes

1

The Rate Of Wound Healing

Time frame
2 years
2

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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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