Hand and Foot Skin ReactionEVOONCT06188000
Efficacy of Extra Virgin Olive Oil (EVOO) Supplementation on Hand-Foot Syndrome Incidence in Patients With Capecitabine
A study testing Extra Virgin Olive Oil and Olive Oil in people with Hand and Foot Skin Reaction and Hand and Foot Syndrome, run by Universitas Sriwijaya at 1 site in Indonesia.
Trial summary
The study was aimed to evaluate the efficacy of extra virgin olive oil (EVOO) supplementation compared to placebo to prevent HFS by observing changes in serum COX 2, malondialdehyde (MDA), and TNF α levels in breast cancer and colorectal cancer patients undergoing capecitabine chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hand and Foot Skin Reaction, Hand and Foot Syndrome, Capecitabine
- What is being tested?
- Extra Virgin Olive Oil 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
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 20 Feb 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients pathologically and clinically diagnosed with III or IV stadium of breast cancer or colorectal cancer.
- fully recovered after curative resection within 8 weeks
- receive adjuvant capecitabine based chemotherapy
Who cannot join
- did not meet the eligibility criteria for chemotherapy
- had previous allergy with capecitabine or olive oil
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Mohammad Hoesin
Palembang, South Sumatera, 30126
About this study
Official title: Efficacy of Extra Virgin Olive Oil (EVOO) Supplementation on Serum COX-2, Malondialdehyde, TNF-alpha, and Hand-Foot Syndrome Incidence in Patients With Capecitabine
The study was aimed to evaluate the efficacy of extra virgin olive oil (EVOO) supplementation compared to placebo to prevent HFS by observing changes in serum COX 2, malondialdehyde (MDA), and TNF α levels in breast cancer and colorectal cancer patients undergoing capecitabine chemotherapy. Current study was designed as a single-center prospective randomized clinical trial. The patients were Stage III or Stage IV colorectal and breast cancer patients receiving capecitabine-based chemotherapy who enrolled in the trial voluntarily. All patients were divided randomly into three groups treated with EVOO, olive oil, or placebo. The incidence of hand foot syndrome was documented. The serum COX 2, malondialdehyde (MDA), and TNF α levels before and after chemotherapy was documented.
- Being tested
- Extra Virgin Olive Oil, Olive Oil, Placebo
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra Virgin Olive OilDietary supplement
Also called EVOO
The patients was given extra virgin olive oil, an unrefined (not processed with chemicals or heat) for of olive oil
Olive OilDietary supplement
The patients was given olive oil.
PlaceboDietary supplement
The patients was given empty capsule
| Study group | Role | What they receive |
|---|---|---|
| Extra Virgin Olive Oil | Experimental | The patients was given a capsule contained extra virgin olive oil 15 milliliters twice a day. Receives: Dietary Supplement: Extra Virgin Olive Oil |
| Olive Oil | Active comparator | The patients was given a capsule contained olive oil 15 milliliters twice a day. Receives: Dietary Supplement: Olive Oil |
| Placebo | Placebo comparator | The patients was given an empty capsule twice a day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Foot Syndrome
Patients was documented for hand and foot syndrome using WHO criteria. There were 4 grade assessed by patient symptoms of tingling or burning or painful sensation, palmar or plantar erythema or desquamation, and/or ulceration.
Measured: 3 cycle of chemotherapy (63 days)
Serum COX-2 Concentration
Serum COX-2 Concentration
Measured: 3 cycle of chemotherapy (63 days)
Serum malondialdehyde concentration
Serum malondialdehyde ceoncentration
Measured: 3 cycle of chemotherapy (63 days)
Serum Tumor Necrosis Factor Alpha Concentration
Serum Tumor Necrosis Factor Alpha Concentration
Measured: 3 cycle of chemotherapy (63 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jan 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hand and Foot Skin ReactionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yenny Andayani, Universitas Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188000
- Sponsor's protocol ID
- 069/kepkrsmh/2022
- Acronym
- EVOO
- Status last verified
- Jan 2024
- First submitted
- 14 Mar 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared after the completion of the study and has been subjected to the consent of the individual patients
Publications
Huang XZ, Chen Y, Chen WJ, Zhang X, Wu CC, Wang ZN, Wu J. Clinical evidence of prevention strategies for capecitabine-induced hand-foot syndrome. Int J Cancer. 2018 Jun 15;142(12):2567-2577. doi: 10.1002/ijc.31269. Epub 2018 Feb 2.
PubMed 29355976Deng B, Sun W. Herbal medicine for hand-foot syndrome induced by fluoropyrimidines: A systematic review and meta-analysis. Phytother Res. 2018 Jul;32(7):1211-1228. doi: 10.1002/ptr.6068. Epub 2018 Apr 16.
PubMed 29682836Elyasi S, Rasta S, Taghizadeh-Kermani A, Hosseini S. Topical henna and curcumin (Alpha(R)) ointment efficacy for prevention of capecitabine induced hand-foot syndrome: A randomized, triple-blinded, placebo-controlled clinical. Daru. 2022 Jun;30(1):117-125. doi: 10.1007/s40199-022-00438-8. Epub 2022 Mar 23.
PubMed 35320555Zhang RX, Wu XJ, Wan DS, Lu ZH, Kong LH, Pan ZZ, Chen G. Celecoxib can prevent capecitabine-related hand-foot syndrome in stage II and III colorectal cancer patients: result of a single-center, prospective randomized phase III trial. Ann Oncol. 2012 May;23(5):1348-1353. doi: 10.1093/annonc/mdr400. Epub 2011 Sep 22.
PubMed 21940785Yap YS, Kwok LL, Syn N, Chay WY, Chia JWK, Tham CK, Wong NS, Lo SK, Dent RA, Tan S, Mok ZY, Koh KX, Toh HC, Koo WH, Loh M, Ng RCH, Choo SP, Soong RCT. Predictors of Hand-Foot Syndrome and Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1538-1545. doi: 10.1001/jamaoncol.2017.1269.
PubMed 28715540
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extra Virgin Olive Oil (EVOO) Supplementation on Serum COX-2, Malondialdehyde, TNF-alpha, and Hand-Foot Syndrome Incidence in Patients With Capecitabine
- ClinicalTrials.gov ID
- NCT06188000
- Acronym / sponsor ID
- EVOO / 069/kepkrsmh/2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 3 Jan 2024 (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.
The study was aimed to evaluate the efficacy of extra virgin olive oil (EVOO) supplementation compared to placebo to prevent HFS by observing changes in serum COX 2, malondialdehyde (MDA), and TNF α levels in breast cancer and colorectal cancer patients undergoing capecitabine chemotherapy. Current study was designed as a single-center prospective randomized clinical trial. The patients were Stage III or Stage IV colorectal and breast cancer patients receiving capecitabine-based chemotherapy who enrolled in the trial voluntarily. All patients were divided randomly into three groups treated with EVOO, olive oil, or placebo. The incidence of hand foot syndrome was documented. The serum COX 2, malondialdehyde (MDA), and TNF α levels before and after chemotherapy was documented.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extra Virgin Olive Oil | Experimental | Dietary Supplement: Extra Virgin Olive OilThe patients was given a capsule contained extra virgin olive oil 15 milliliters twice a day. |
| Olive Oil | Active comparator | Dietary Supplement: Olive OilThe patients was given a capsule contained olive oil 15 milliliters twice a day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe patients was given an empty capsule twice a day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients pathologically and clinically diagnosed with III or IV stadium of breast cancer or colorectal cancer.
- fully recovered after curative resection within 8 weeks
- receive adjuvant capecitabine based chemotherapy
Key exclusion criteria (2 listed)
- did not meet the eligibility criteria for chemotherapy
- had previous allergy with capecitabine or olive oil
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 |
|---|---|---|
| Extra Virgin Olive OilAlso: EVOOThe patients was given extra virgin olive oil, an unrefined (not processed with chemicals or heat) for of olive oil | Dietary supplement | Extra Virgin Olive Oil |
| Olive OilThe patients was given olive oil. | Dietary supplement | Olive Oil |
| PlaceboThe patients was given empty capsule | Dietary supplement | Placebo |
Primary outcome
Hand Foot Syndrome
Time frame: 3 cycle of chemotherapy (63 days)
Patients was documented for hand and foot syndrome using WHO criteria. There were 4 grade assessed by patient symptoms of tingling or burning or painful sensation, palmar or plantar erythema or desquamation, and/or ulceration.
Serum COX-2 Concentration
Time frame: 3 cycle of chemotherapy (63 days)
Serum COX-2 Concentration
Serum malondialdehyde concentration
Time frame: 3 cycle of chemotherapy (63 days)
Serum malondialdehyde ceoncentration
Serum Tumor Necrosis Factor Alpha Concentration
Time frame: 3 cycle of chemotherapy (63 days)
Serum Tumor Necrosis Factor Alpha Concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 29355976Huang XZ, Chen Y, Chen WJ, Zhang X, Wu CC, Wang ZN, Wu J. Clinical evidence of prevention strategies for capecitabine-induced hand-foot syndrome. Int J Cancer. 2018 Jun 15;142(12):2567-2577. doi: 10.1002/ijc.31269. Epub 2018 Feb 2.
- Background: PubMed 29682836Deng B, Sun W. Herbal medicine for hand-foot syndrome induced by fluoropyrimidines: A systematic review and meta-analysis. Phytother Res. 2018 Jul;32(7):1211-1228. doi: 10.1002/ptr.6068. Epub 2018 Apr 16.
- Background: PubMed 35320555Elyasi S, Rasta S, Taghizadeh-Kermani A, Hosseini S. Topical henna and curcumin (Alpha(R)) ointment efficacy for prevention of capecitabine induced hand-foot syndrome: A randomized, triple-blinded, placebo-controlled clinical. Daru. 2022 Jun;30(1):117-125. doi: 10.1007/s40199-022-00438-8. Epub 2022 Mar 23.
- Results publication: PubMed 21940785Zhang RX, Wu XJ, Wan DS, Lu ZH, Kong LH, Pan ZZ, Chen G. Celecoxib can prevent capecitabine-related hand-foot syndrome in stage II and III colorectal cancer patients: result of a single-center, prospective randomized phase III trial. Ann Oncol. 2012 May;23(5):1348-1353. doi: 10.1093/annonc/mdr400. Epub 2011 Sep 22.
- Results publication: PubMed 28715540Yap YS, Kwok LL, Syn N, Chay WY, Chia JWK, Tham CK, Wong NS, Lo SK, Dent RA, Tan S, Mok ZY, Koh KX, Toh HC, Koo WH, Loh M, Ng RCH, Choo SP, Soong RCT. Predictors of Hand-Foot Syndrome and Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1538-1545. doi: 10.1001/jamaoncol.2017.1269.
- Individual participant dataSharing planned: No. The data will be shared after the completion of the study and has been subjected to the consent of the individual patients
Related trials for Hand and Foot Skin Reaction
Recruiting
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
Hand-foot Syndrome, Hand-foot Skin Reaction
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 Extra Virgin Olive Oil and Olive Oil in people with Hand and Foot Skin Reaction and Hand and Foot Syndrome, run by Universitas Sriwijaya at 1 site in Indonesia.
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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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 Indonesia. 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?
Results are not available in the source record.
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?
Hand Foot Syndrome (time frame: 3 cycle of chemotherapy (63 days)). The study lists 4 primary outcomes in all. 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 NCT06188000, which also lists 5 linked publications.
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 3 Jan 2024.