Tumor SurgeryNCT02792270
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
A study testing Caloric Restriction Diet in people with Tumor Surgery, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Surgery
- What is being tested?
- Caloric Restriction Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
- Body Mass Index (BMI) ≥ 20 kg/m2
- Protein levels within normal limits within 45 days of enrollment
Show all 9Show fewer
- Normal kidney and liver function within 45 days of enrollment
- Normal blood counts within 45 days of enrollment
- Normal chemistries within 45 days of enrollment
Who cannot join
- 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, allergic reaction to shake, patient decides not to have surgery, any medical condition that prevents patient from having surgery)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts general Hospital
Boston, Massachusetts, 02114
Santiago A Lozano-Calderón, MD, PhD, 617-643-4947, slozanocalderon@mgh.harvard.edu
Shreya Halur, BS, 617-726-4932, shalur@mgh.harvard.edu
About this study
Official title: Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy
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.
Read the 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.
- Conditions
- Tumor Surgery
- Being tested
- Caloric Restriction Diet
- Keywords
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric Restriction DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Caloric Restriction Diet | Experimental | Patients will meet with the Registered Dietitian to discuss calorie, protein, and fluid needs.The dietitian will calculate calorie needs.
* Calorie needs will be reduced by 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. Receives: Other: Caloric Restriction Diet |
| Normal Diet | No intervention | Participant will follow a normal diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 3 months and 6 months visits after surgery
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.
Measured: Baseline, 6 weeks, 3 months and 6 months visits after surgery
Secondary outcomes (2)
The Rate Of Wound Healing
Measured: 2 years
The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor SurgeryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Lozano-Calderon, Massachusetts General Hospital
- Investigators
- Santiago A Lozano-Calderón, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792270
- Sponsor's protocol ID
- 15-485
- Status last verified
- May 2026
- First submitted
- 16 May 2016
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Caloric Restriction On Post-Operative Complications In Sarcoma Patients Treated With Pre-Operative Radiation Therapy
- ClinicalTrials.gov ID
- NCT02792270
- Acronym / sponsor ID
- 15-485
- Conditions
- Tumor Surgery
- Keywords
- Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caloric Restriction Diet | Experimental | Other: Caloric Restriction DietPatients will meet with the Registered Dietitian to discuss calorie, protein, and fluid needs.The dietitian will calculate calorie needs. * Calorie needs will be reduced by 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. |
| Normal Diet | No intervention | –Participant will follow a normal diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%
- Body Mass Index (BMI) ≥ 20 kg/m2
Key exclusion criteria (5 listed)
- 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, allergic reaction to shake, patient decides not to have surgery, any medical condition that prevents patient from having surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric Restriction DietTwo 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. | Other | Caloric Restriction Diet |
Primary outcome
Change In The Rate Of Physical Function By MSTS
Time frame: Baseline, 6 weeks, 3 months and 6 months visits after surgery
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.
Change In The Rate Of Physical Function By TESS
Time frame: Baseline, 6 weeks, 3 months and 6 months visits after surgery
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.
2 secondary outcomes
The Rate Of Wound Healing
Time frame: 2 years
The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Santiago A Lozano-Calderón, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Restriction Diet in people with Tumor Surgery, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Santiago A Lozano-Calderón, MD, PhD (617-643-4947, slozanocalderon@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change In The Rate Of Physical Function By MSTS (time frame: Baseline, 6 weeks, 3 months and 6 months visits after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.