Abdominal CancerPhase 4NCT04687124
EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -
A Phase 4 study testing Fish oil in people with Abdominal Cancer and Radiotherapy; Complications, run by Jens Rikardt Andersen at 1 site in Denmark.
Trial summary
Malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal (GI) area and can lead to negative outcomes. N-3 fatty acids from fish, especially eicosapentaenoic acid (EPA) may possess anticachectic properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer, Radiotherapy; Complications, Weight Loss
- What is being tested?
- Fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2018to Feb 2021
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referred to radiotherapy for dissminated, abdominal cancer
- > 18 years of age
- able to understand and comply with the intervention
- willingness to participate after oral and written conscent
Who cannot join
- conditions precluding evaluations of end-points
- dementia
- operations planned in the observation period
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Oncology, Rigshospitalet
Copenhagen, 2100
Jens R Andersen, +45 454523346654, jra@nexs.ku.dk
Grith Møller, +45, gmp@nexs.ku.dk
About this study
Official title: N-3 Fatty Acid EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy - A Randomised Controlled Trial.
Malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal (GI) area and can lead to negative outcomes. N-3 fatty acids from fish, especially eicosapentaenoic acid (EPA) may possess anticachectic properties. The aim of this study is to investigate the effect of two nutritional interventions; dietary counselling and an oral nutritional supplement (ONS) containing 2.2 g of the n-3 fatty acid EPA (Forticare®) or standard care, including dietary counselling and protein supplementation when needed.
Read the detailed description
Methods: Outpatients commencing radiotherapy to the GI area due to dissiminated cancer are randomized to receive dietary counselling and daily fish-oil supplementation over a 5-7 week period, or standard care. Outcome parameters are measured at baseline (onset of radiotherapy), week 5, and 12 weeks after commencing radiotherapy, with one additional measurement of body weight at week 2. Quality of life (QoL) is measured using the EORTC QLQ-C30 questionnaire. Radiotherapy-related side effects are assessed using a questionnaire developed specifically for this study. Data from a historical control group collected in a previous observational study is included in this study to compare incidence of weight loss.
- Conditions
- Abdominal Cancer, Radiotherapy; Complications, Weight Loss, Energy Supply, Protein Deficiency
- Being tested
- Fish oil, standard care
- Keywords
- Malnutrition, radiotherapy,, oral nutritional supplements, fish-oil
- Medical subject headings
- Weight Loss, Protein Deficiency, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
Also called Dietary counseling
Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)
standard careOther
No specified intervention
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Active comparator | dietary counselling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®) Receives: Dietary Supplement: Fish oil |
| standard care | Placebo comparator | The departmental usual procedure with the possibility of requiring of a dietician when needed Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight (%)
accumulated weight-loss or gain in per cent of the weight measured between baseline, end of treatment and at follow-up
Measured: 6 weeks
Secondary outcomes (4)
energy intake (kJ/day) in % of estimated needs
Mean of 3 meausrements in the obeservation period
Measured: 6 weeks
protein intake (g/kg body weight/day) in % of estimated needs
Mean of 3 meausrements in the obeservation period
Measured: 6 weeks
Quality of life score (EORTC QLQ-C30 version 3.0) points
difference - before and after intervention
Measured: 6 weeks
treatment-related side-effects (VAS) scale
questionaire before and after intervention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start15 Feb 2018
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization by sealed envelopes. Stratified for location of cancer
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687124
- Sponsor's protocol ID
- H-D-2007-0134
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patursson P, Moller G, Muhic A, Andersen JR. N-3 fatty acid EPA supplementation in cancer patients receiving abdominal radiotherapy - A randomised controlled trial. Clin Nutr ESPEN. 2021 Jun;43:130-136. doi: 10.1016/j.clnesp.2021.03.001. Epub 2021 Mar 16.
PubMed 34024504
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-3 Fatty Acid EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy - A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04687124
- Acronym / sponsor ID
- H-D-2007-0134
- Conditions
- Abdominal Cancer, Radiotherapy; Complications, Weight Loss, Energy Supply, Protein Deficiency
- Keywords
- Malnutrition, radiotherapy,, oral nutritional supplements, fish-oil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 29 Dec 2020 (actual)
- 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.
Malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal (GI) area and can lead to negative outcomes. N-3 fatty acids from fish, especially eicosapentaenoic acid (EPA) may possess anticachectic properties. The aim of this study is to investigate the effect of two nutritional interventions; dietary counselling and an oral nutritional supplement (ONS) containing 2.2 g of the n-3 fatty acid EPA (Forticare®) or standard care, including dietary counselling and protein supplementation when needed.
Detailed description
Methods: Outpatients commencing radiotherapy to the GI area due to dissiminated cancer are randomized to receive dietary counselling and daily fish-oil supplementation over a 5-7 week period, or standard care. Outcome parameters are measured at baseline (onset of radiotherapy), week 5, and 12 weeks after commencing radiotherapy, with one additional measurement of body weight at week 2. Quality of life (QoL) is measured using the EORTC QLQ-C30 questionnaire. Radiotherapy-related side effects are assessed using a questionnaire developed specifically for this study. Data from a historical control group collected in a previous observational study is included in this study to compare incidence of weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization by sealed envelopes. Stratified for location of cancer
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Active comparator | Dietary Supplement: Fish oildietary counselling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®) |
| standard care | Placebo comparator | Other: standard careThe departmental usual procedure with the possibility of requiring of a dietician when needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- referred to radiotherapy for dissminated, abdominal cancer
- > 18 years of age
- able to understand and comply with the intervention
- willingness to participate after oral and written conscent
Key exclusion criteria (3 listed)
- conditions precluding evaluations of end-points
- dementia
- operations planned in the observation period
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 |
|---|---|---|
| Fish oilAlso: Dietary counselingDietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®) | Dietary supplement | Fish oil |
| standard careNo specified intervention | Other | standard care |
Primary outcome
Change in weight (%)
Time frame: 6 weeks
accumulated weight-loss or gain in per cent of the weight measured between baseline, end of treatment and at follow-up
4 secondary outcomes
energy intake (kJ/day) in % of estimated needs
Time frame: 6 weeks
protein intake (g/kg body weight/day) in % of estimated needs
Time frame: 6 weeks
Quality of life score (EORTC QLQ-C30 version 3.0) points
Time frame: 6 weeks
treatment-related side-effects (VAS) scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Derived from this study: PubMed 34024504Patursson P, Moller G, Muhic A, Andersen JR. N-3 fatty acid EPA supplementation in cancer patients receiving abdominal radiotherapy - A randomised controlled trial. Clin Nutr ESPEN. 2021 Jun;43:130-136. doi: 10.1016/j.clnesp.2021.03.001. Epub 2021 Mar 16.
- Individual participant dataSharing planned: No
Related trials for Abdominal Cancer
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 3
A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Ovarian Neoplasms, Fallopian Tube Neoplasms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fish oil in people with Abdominal Cancer and Radiotherapy; Complications, run by Jens Rikardt Andersen at 1 site in Denmark.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Dec 2020. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens R Andersen, MD,MPA (+4523346654, jra@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (%) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04687124, which also lists 1 linked publication.
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 29 Dec 2020.