Hematopoietic Stem Cell TransplantationNCT02791347
Nutrition Intervention Among Stem Cell Recipients: Post Hospital Discharge
A study testing Nutrition Intervention in people with Hematopoietic Stem Cell Transplantation and Malnutrition, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Chemotherapy conditioning, preceding Stem Cell Transplantation (SCT), has been associated with severe gastrointestinal toxicity, commonly compromising patients' food intake, nutritional status and functioning level. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Malnutrition
- What is being tested?
- Nutrition Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteLebanon
- Study dates
- Aug 2016to Jan 2018
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults admitted to the adult BMT service at AUBMC
- Allogeneic or autologous SCT
- Malignant or non-malignant indication for SCT
Who cannot join
- Patients who pass away before day +100
- Patients who miss 2 assessment points
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition Intervention Among Stem Cell Recipients: a Randomized Controlled Trial Post Hospital Discharge
Chemotherapy conditioning, preceding Stem Cell Transplantation (SCT), has been associated with severe gastrointestinal toxicity, commonly compromising patients' food intake, nutritional status and functioning level. Malnutrition has been associated with worse functional status, reduced survival, increased rate of infections, complications, hospitalizations, and therapy toxicity in oncology patients.
To date, there is no Randomized Controlled Trials (RCT) assessing the impact of a nutrition intervention on SCT patients who remain at risk of malnutrition even 100 days post SCT. The proposed study is a single center, prospective, RCT with a parallel design that aims to assess the impact of a nutrition intervention on the nutritional and functional statuses of SCT recipients 100 days post SCT.
Read the detailed description
This study is a single center RCT with a parallel design. It aims to improve the SCT recipients' nutritional status and QoL and reduce the associated morbidities. Results of the study can guide the recommendations for the medical and nutritional outpatient assessment post SCT.
During the pre-SCT workup, patients will be invited to participate in the study. Around discharge from the hospital, recruited patients will be randomized to a control or an intervention group based on permuted block random sampling. Patients in the Nutrition Intervention group (NIG) will receive a tailored diet plan from the dietitian as well as regular outpatient follow-ups measuring and reinforcing compliance. Patients in the Control Group (CG) will receive usual care; they will only be assessed in the nutrition clinics upon referral by the medical team. The body composition, Quality of Life (QoL), Physical Activity (PA) level, nutrient intake, functional status and nutritional status of both groups will be evaluated at regular intervals during the hospital stay and post discharge through the Patient Generated Subjective Global Assessment (PGSGA), Body Impedance Analysis (BIA), handgrip strength, Functional Assessment of Cancer Therapy -Bone Marrow Transplantation (FACT-BMT), PA questionnaire and Karnofsky scale. Moreover, patients' food intake will be analyzed for its micronutrient and macronutrient content to assess the changes in nutrient analysis in the peri-transplantation phase. When applicable, BIA and Computed Tomography (CT) tests will be compared for their agreements.
Considering a power of 80%, an attrition rate of 30% and a difference of 40% between the NIG and CG groups, 52 patients need to be recruited in the study. Analysis will be done based on 'intention to treat' and 'per protocol' analysis.
- Being tested
- Nutrition Intervention
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Upon discharge from the medical center, patients would be advised on a qualitative, neutropenic diet. Participants' quality of life, physical activity level, functional and nutritional status would be assessed at days +30, +60 and +100 post transplantation. These participants will not receive nutritional counseling by the dietitian as outpatients except if referred by the medical team. |
| Nutrition Intervention Group | Experimental | Upon discharge from the medical center, NIG patients will receive tailored nutrition counseling with the provision of patient education material and oral nutritional supplements if needed. Patients will be advised on a diet high in energy and proteins and tailored to their medical condition in the hospital before discharge.
Patients will be followed up at days +30, +60 and +100 post transplantation. Compliance will be measured at each visit by comparing patients caloric and protein needs to their actual protein and energy intake. Compliance will be reinforced to meet patients' goals using nutritional tips, oral supplementation, and artificial nutrition use. Receives: Other: Nutrition Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a PGSGA score ≥4
Measured: 100 days post transplantation
Secondary outcomes (4)
Handgrip strength
Measured: 100 days post transplantation
Lean Body Mass Changes
Measured: 100 days post transplantation
Re-hospitalization Rate
Measured: 100 days post transplantation
Quality of life (QoL) [ Time Frame: 100 days post transplantation ]
Measured: 100 days post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aix Marseille Université
- Responsible party
- Principal investigator, Jean El Sheikh, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791347
- Sponsor's protocol ID
- IM.J-EC.01
- Status last verified
- Feb 2018
- First submitted
- 1 Jun 2016
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Intervention Among Stem Cell Recipients: a Randomized Controlled Trial Post Hospital Discharge
- ClinicalTrials.gov ID
- NCT02791347
- Acronym / sponsor ID
- IM.J-EC.01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Aix Marseille Université
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 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.
Chemotherapy conditioning, preceding Stem Cell Transplantation (SCT), has been associated with severe gastrointestinal toxicity, commonly compromising patients' food intake, nutritional status and functioning level. Malnutrition has been associated with worse functional status, reduced survival, increased rate of infections, complications, hospitalizations, and therapy toxicity in oncology patients.
To date, there is no Randomized Controlled Trials (RCT) assessing the impact of a nutrition intervention on SCT patients who remain at risk of malnutrition even 100 days post SCT. The proposed study is a single center, prospective, RCT with a parallel design that aims to assess the impact of a nutrition intervention on the nutritional and functional statuses of SCT recipients 100 days post SCT.
Detailed description
This study is a single center RCT with a parallel design. It aims to improve the SCT recipients' nutritional status and QoL and reduce the associated morbidities. Results of the study can guide the recommendations for the medical and nutritional outpatient assessment post SCT.
During the pre-SCT workup, patients will be invited to participate in the study. Around discharge from the hospital, recruited patients will be randomized to a control or an intervention group based on permuted block random sampling. Patients in the Nutrition Intervention group (NIG) will receive a tailored diet plan from the dietitian as well as regular outpatient follow-ups measuring and reinforcing compliance. Patients in the Control Group (CG) will receive usual care; they will only be assessed in the nutrition clinics upon referral by the medical team. The body composition, Quality of Life (QoL), Physical Activity (PA) level, nutrient intake, functional status and nutritional status of both groups will be evaluated at regular intervals during the hospital stay and post discharge through the Patient Generated Subjective Global Assessment (PGSGA), Body Impedance Analysis (BIA), handgrip strength, Functional Assessment of Cancer Therapy -Bone Marrow Transplantation (FACT-BMT), PA questionnaire and Karnofsky scale. Moreover, patients' food intake will be analyzed for its micronutrient and macronutrient content to assess the changes in nutrient analysis in the peri-transplantation phase. When applicable, BIA and Computed Tomography (CT) tests will be compared for their agreements.
Considering a power of 80%, an attrition rate of 30% and a difference of 40% between the NIG and CG groups, 52 patients need to be recruited in the study. Analysis will be done based on 'intention to treat' and 'per protocol' analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Upon discharge from the medical center, patients would be advised on a qualitative, neutropenic diet. Participants' quality of life, physical activity level, functional and nutritional status would be assessed at days +30, +60 and +100 post transplantation. These participants will not receive nutritional counseling by the dietitian as outpatients except if referred by the medical team. |
| Nutrition Intervention Group | Experimental | Other: Nutrition InterventionUpon discharge from the medical center, NIG patients will receive tailored nutrition counseling with the provision of patient education material and oral nutritional supplements if needed. Patients will be advised on a diet high in energy and proteins and tailored to their medical condition in the hospital before discharge. Patients will be followed up at days +30, +60 and +100 post transplantation. Compliance will be measured at each visit by comparing patients caloric and protein needs to their actual protein and energy intake. Compliance will be reinforced to meet patients' goals using nutritional tips, oral supplementation, and artificial nutrition use. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults admitted to the adult BMT service at AUBMC
- Allogeneic or autologous SCT
- Malignant or non-malignant indication for SCT
Key exclusion criteria (2 listed)
- Patients who pass away before day +100
- Patients who miss 2 assessment points
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 |
|---|---|---|
| Nutrition Intervention | Other | Nutrition Intervention Group |
Primary outcome
Proportion of patients with a PGSGA score ≥4
Time frame: 100 days post transplantation
4 secondary outcomes
Handgrip strength
Time frame: 100 days post transplantation
Lean Body Mass Changes
Time frame: 100 days post transplantation
Re-hospitalization Rate
Time frame: 100 days post transplantation
Quality of life (QoL) [ Time Frame: 100 days post transplantation ]
Time frame: 100 days post transplantation
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 8 Feb 2018.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Intervention in people with Hematopoietic Stem Cell Transplantation and Malnutrition, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 8 Feb 2018. 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 Lebanon. 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?
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?
Proportion of patients with a PGSGA score ≥4 (time frame: 100 days post transplantation). 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 8 Feb 2018.