SarcopeniaNCT02779868
Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy
A study testing Omega-3 and Olive oil in people with Sarcopenia, run by Brazilian National Cancer Institute at 1 site in Brazil.
Trial summary
Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in cancer cachexia. Read more about this study
- Who is it for?
- Ages 20 to 59 years, women only
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Omega-3 and Olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Cervix cancer at FIGO stage II and III
- Chemoradiotherapy treatment proposal (cisplatin + radiotherapy)
- Nutritional diagnosis of pre-cachexia ou cachexia
Who cannot join
- metastasis (FIGO stage IV)
- Nutritional diagnosis of refractary cachexia
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Brazilian National Cancer Institute
Rio de Janeiro, Rio de Janeiro, 20220-410
About this study
Official title: Effect of Omega-3 Supplementation on Body Composition, Functional Capacity, Inflammatory Profile and Quality of Life in Cervix Cancer Patients Undergoing Chemoradiotherapy
Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could potentially maintain body weight in cancer patients undergoing intensive treatment.
The investigators aims in this study is to evaluate the effect of omega-3 supplementation on body composition, functional capacity, inflammatory profile and quality of life in cervix cancer patients undergoing chemoradiotherapy.
- Conditions
- Sarcopenia
- Being tested
- Omega-3, Olive oil
- Keywords
- body composition, functional capacity, quality of life
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called intervention group
patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.
Olive oilDietary supplement
Also called placebo group
patients included in this group will take 4 capsules per day of olive oil.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol. Receives: Dietary Supplement: Omega-3 |
| Olive oil | Placebo comparator | Group who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol. Receives: Dietary Supplement: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body composition
Change from baseline body composition assessed by computed tomography scans before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
Measured: 45 days
Secondary outcomes (10)
Change in Quality of life
Change in quality of life assessed by EORCT QL30 questionaire before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
Measured: 45 days
Change in Quality of life
Change in quality of life assessed by and EQ-5D-3L questionaire before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
Measured: 45 days
Change in IL-6 serum levels
Change in serum levels of IL-6 (ng/mL) before and at the end of chemotherapy (45 days)
Measured: 45 days
Change in IL-1 serum levels
Change in serum levels of IL-1 (ng/mL) before and at the end of chemotherapy (45 days)
Measured: 45 days
Change in TNF-alfa serum levels
Change in serum levels of TNF-alfa (ng/mL) before and at the end of chemotherapy (45 days)
Measured: 45 days
Change in INF-gama serum levels
Change in serum levels of INF-gama (ng/mL) before and at the end of chemotherapy (45 days)
Measured: 45 days
Change in membrane incorporation of non-esterified fatty acids
Change in membrane incorporation of non-esterified fatty acids assessed by Gas chromatography of fatty acid methyl esters (nmol/mL)
Measured: 45 days
Change in handgrip strength
change in handgrip strength before and at the end of chemotherapy treatment (45 days)
Measured: 45 days
Change in functional capacity (30 second stand chair test)
change in functional capacity assessed by 30 second stand chair test before and at the end of chemotherapy treatment (45 days)
Measured: 45 days
chemoradiotherapy toxicity
chemoradiotherapy will be assessed by Chemotherapy toxicity criteria (CTC) version 4.0
Measured: 15 and 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brazilian National Cancer Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gabriela Villaça Chaves, Brazilian National Cancer Institute
- Investigators
- Mariah A Aredes, Ms, Study chair, Brazilian National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779868
- Sponsor's protocol ID
- 1.150.108/2015
- Status last verified
- Jul 2017
- First submitted
- 17 May 2016
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega-3 Supplementation on Body Composition, Functional Capacity, Inflammatory Profile and Quality of Life in Cervix Cancer Patients Undergoing Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02779868
- Acronym / sponsor ID
- 1.150.108/2015
- Conditions
- Sarcopenia
- Keywords
- body composition, functional capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brazilian National Cancer InstituteOther government
- Study start
- May 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 May 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.
Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could potentially maintain body weight in cancer patients undergoing intensive treatment.
The investigators aims in this study is to evaluate the effect of omega-3 supplementation on body composition, functional capacity, inflammatory profile and quality of life in cervix cancer patients undergoing chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: Omega-3Group who will receive 2g eicosapentaenoic (4 capsules) acid per day during the chemoradiotherapy protocol. |
| Olive oil | Placebo comparator | Dietary Supplement: Olive oilGroup who will receive olive oil per day (4 capsules) during the chemoradiotherapy protocol. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cervix cancer at FIGO stage II and III
- Chemoradiotherapy treatment proposal (cisplatin + radiotherapy)
- Nutritional diagnosis of pre-cachexia ou cachexia
Key exclusion criteria (2 listed)
- metastasis (FIGO stage IV)
- Nutritional diagnosis of refractary cachexia
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 |
|---|---|---|
| Omega-3Also: intervention grouppatients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid. | Dietary supplement | Omega-3 |
| Olive oilAlso: placebo grouppatients included in this group will take 4 capsules per day of olive oil. | Dietary supplement | Olive oil |
Primary outcome
Change in Body composition
Time frame: 45 days
Change from baseline body composition assessed by computed tomography scans before and at the end of chemotherapy treatment (45 day after the first chemotherapy)
10 secondary outcomes
Change in Quality of life
Time frame: 45 days
Change in Quality of life
Time frame: 45 days
Change in IL-6 serum levels
Time frame: 45 days
Change in IL-1 serum levels
Time frame: 45 days
Change in TNF-alfa serum levels
Time frame: 45 days
Change in INF-gama serum levels
Time frame: 45 days
Change in membrane incorporation of non-esterified fatty acids
Time frame: 45 days
Change in handgrip strength
Time frame: 45 days
Change in functional capacity (30 second stand chair test)
Time frame: 45 days
chemoradiotherapy toxicity
Time frame: 15 and 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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. This study is not recruiting at the moment.
Mariah A Aredes, Ms study chair
Brazilian National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 and Olive oil in people with Sarcopenia, run by Brazilian National Cancer Institute at 1 site in Brazil.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jul 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body composition (time frame: 45 days). 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 25 Jul 2017.