Chemotherapy-induced Nausea and VomitingPhase 2CapCINNCT04918069
Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN)
A Phase 2 study testing Capsaicin in people with Chemotherapy-induced Nausea and Vomiting, run by Christian Medical College, Vellore, India at 1 site in India.
Trial summary
Chemotherapy-induced nausea and vomiting (CINV) is one of the few most severe adverse effects of chemotherapy, which often panic patients undergoing cancer treatment. Though acute episodes of CINV are well controlled with pharmacologic agents, delayed CINV continues to present a treatment challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIndia
- Study dates
- 18 Oct 2019to 14 May 2022
- Phase
- Phase 2
- 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
- Adult chemotherapy naïve patients of at least 18 years old
- Diagnosed with a malignant disease and scheduled for highly emetogenic chemotherapy (as defined by NCCN guidelines v1.2019)
- No concurrent radiotherapy or use of other antiemetic drugs except (dexamethasone, ondansetron/granisetron, and olanzapine)
- Normal renal and hepatic function
Who cannot join
- Pregnant or breast feeding
- Contraindication for capsaicin or other medications in the study
- Has ongoing nausea and/or vomiting of other etiology
- History of anticipatory nausea and/or vomiting or has vomited/nauseated within 24 hours prior to the start of scheduled chemotherapy
- Chronic alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-blinded, Randomized Study of Capsaicin to Prevent Delayed Chemotherapy-induced Nausea and Vomiting
Chemotherapy-induced nausea and vomiting (CINV) is one of the few most severe adverse effects of chemotherapy, which often panic patients undergoing cancer treatment. Though acute episodes of CINV are well controlled with pharmacologic agents, delayed CINV continues to present a treatment challenge.
Significant progress has been made over the past many years in discovering the pathophysiology of CINV. Primarily, three areas in the brain including central pattern generator (CPG), nucleus tractus solitarius (NTS) and area postrema (AP) are implicated in generating emetic reflex in all types of CINV (anticipatory, acute and delayed). The latter two areas NTS and AP are located at the caudal end of the fourth ventricle of brain which lies outside of the blood brain barrier and hence are stimulated by agents present in either blood and/or cerebrospinal fluid (CSF). Furthermore, NTS and AP are rich in muscarinic, dopamine, serotonin, neurokinin (NK1) and histamine receptors which are particularly important in delayed CINV. Clinical trials of antimuscarinic, antidopaminergic, antihistaminic drugs to prevent CINV have yielded inconclusive results except for olanzapine which is known to act on multiple receptors in NTS/AP. Only NK1 antagonists (e.g. aprepitant) which prevent substance P (SP) from binding to NK1 receptors have shown promising results and are clinically used to prevent delayed CINV. SP is a tachykinin peptide encoded by TAC1 (tachykinin precursor 1) gene and is found abundant in both peripheral and CNS. NK1 receptors in NTS/AP upon binding with SP will generate emetic reflex which will trigger delayed CINV. Though the topical analgesic drug capsaicin is reported to interfere with endogenous SP, its antiemetic potential in CINV has not been studied. This study intend to explore the antiemetic potential of capsaicin which is known to interfere with SP release in the GIT and CNS.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Capsaicin, Placebo
- Keywords
- Chemotherapy, Capsaicin, Nausea and Vomiting
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Topical capsaicin ointment
PlaceboDrug
Topical placebo ointment
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Experimental | 2g of 0.075% topical capsaicin ointment applied four times daily (preferably to the abdomen) for the first five days of chemotherapy Receives: Drug: Capsaicin |
| Placebo | Placebo comparator | 2g of topical placebo ointment applied four times daily (preferably to the abdomen) for the first five days of chemotherapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea
Number of participants with chemotherapy-induced nausea that occurs after 24 hours of the first cycle
Measured: Within 15 days of chemotherapy
Vomiting
Number of participants with chemotherapy-induced vomiting that occurs after 24 hours of the first cycle
Measured: Within 15 days of chemotherapy
Secondary outcomes (3)
Overall chemotherapy-induced nausea and vomiting
Number of participants with both immediate and delayed chemotherapy-induced nausea and vomiting
Measured: Within 15 days of chemotherapy
Severity of chemotherapy-induced nausea and vomiting
Number of participants with severe, moderate and mild chemotherapy-induced nausea and vomiting
Measured: Within 15 days of chemotherapy
Use of rescue medication
Number of participants requiring rescue medication for nausea and vomiting
Measured: Within 15 days of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start18 Oct 2019
- Primary completion14 May 2022
- Study completion14 May 2022
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 Chemotherapy-induced Nausea and VomitingStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Medical College, Vellore, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heber Rew Bright, Christian Medical College, Vellore, India
- Investigators
- Heber Rew Bright, MPharm, Principal investigator, Christian Medical College, Vellore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918069
- Sponsor's protocol ID
- 11995
- Acronym
- CapCIN
- Status last verified
- May 2022
- First submitted
- 2 Jun 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared depending on prevailing local institutional policies.
Publications
Bright HR, Singh A, Joel A, Georgy JT, John AO, Rajkumar P, Jiji H, Stehno-Bittel L, Samuel P, Chandy SJ. Randomized Placebo-Controlled Trial of Topical Capsaicin for Delayed Chemotherapy-Induced Nausea and Vomiting. JCO Glob Oncol. 2024 Jun;10:e2400130. doi: 10.1200/GO.24.00130.
PubMed 38905580
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blinded, Randomized Study of Capsaicin to Prevent Delayed Chemotherapy-induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT04918069
- Acronym / sponsor ID
- CapCIN / 11995
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Chemotherapy, Capsaicin, Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Christian Medical College, Vellore, IndiaUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 14 May 2022 (actual)
- Study completion
- 14 May 2022 (actual)
- First posted
- 8 Jun 2021 (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.
Chemotherapy-induced nausea and vomiting (CINV) is one of the few most severe adverse effects of chemotherapy, which often panic patients undergoing cancer treatment. Though acute episodes of CINV are well controlled with pharmacologic agents, delayed CINV continues to present a treatment challenge.
Significant progress has been made over the past many years in discovering the pathophysiology of CINV. Primarily, three areas in the brain including central pattern generator (CPG), nucleus tractus solitarius (NTS) and area postrema (AP) are implicated in generating emetic reflex in all types of CINV (anticipatory, acute and delayed). The latter two areas NTS and AP are located at the caudal end of the fourth ventricle of brain which lies outside of the blood brain barrier and hence are stimulated by agents present in either blood and/or cerebrospinal fluid (CSF). Furthermore, NTS and AP are rich in muscarinic, dopamine, serotonin, neurokinin (NK1) and histamine receptors which are particularly important in delayed CINV. Clinical trials of antimuscarinic, antidopaminergic, antihistaminic drugs to prevent CINV have yielded inconclusive results except for olanzapine which is known to act on multiple receptors in NTS/AP. Only NK1 antagonists (e.g. aprepitant) which prevent substance P (SP) from binding to NK1 receptors have shown promising results and are clinically used to prevent delayed CINV. SP is a tachykinin peptide encoded by TAC1 (tachykinin precursor 1) gene and is found abundant in both peripheral and CNS. NK1 receptors in NTS/AP upon binding with SP will generate emetic reflex which will trigger delayed CINV. Though the topical analgesic drug capsaicin is reported to interfere with endogenous SP, its antiemetic potential in CINV has not been studied. This study intend to explore the antiemetic potential of capsaicin which is known to interfere with SP release in the GIT and CNS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Experimental | Drug: Capsaicin2g of 0.075% topical capsaicin ointment applied four times daily (preferably to the abdomen) for the first five days of chemotherapy |
| Placebo | Placebo comparator | Drug: Placebo2g of topical placebo ointment applied four times daily (preferably to the abdomen) for the first five days of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult chemotherapy naïve patients of at least 18 years old
- Diagnosed with a malignant disease and scheduled for highly emetogenic chemotherapy (as defined by NCCN guidelines v1.2019)
- No concurrent radiotherapy or use of other antiemetic drugs except (dexamethasone, ondansetron/granisetron, and olanzapine)
- Normal renal and hepatic function
Key exclusion criteria (5 listed)
- Pregnant or breast feeding
- Contraindication for capsaicin or other medications in the study
- Has ongoing nausea and/or vomiting of other etiology
- History of anticipatory nausea and/or vomiting or has vomited/nauseated within 24 hours prior to the start of scheduled chemotherapy
- Chronic alcoholism
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 |
|---|---|---|
| CapsaicinTopical capsaicin ointment | Drug | Capsaicin |
| PlaceboTopical placebo ointment | Drug | Placebo |
Primary outcome
Nausea
Time frame: Within 15 days of chemotherapy
Number of participants with chemotherapy-induced nausea that occurs after 24 hours of the first cycle
Vomiting
Time frame: Within 15 days of chemotherapy
Number of participants with chemotherapy-induced vomiting that occurs after 24 hours of the first cycle
3 secondary outcomes
Overall chemotherapy-induced nausea and vomiting
Time frame: Within 15 days of chemotherapy
Severity of chemotherapy-induced nausea and vomiting
Time frame: Within 15 days of chemotherapy
Use of rescue medication
Time frame: Within 15 days of chemotherapy
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 20 May 2022.
- Derived from this study: PubMed 38905580Bright HR, Singh A, Joel A, Georgy JT, John AO, Rajkumar P, Jiji H, Stehno-Bittel L, Samuel P, Chandy SJ. Randomized Placebo-Controlled Trial of Topical Capsaicin for Delayed Chemotherapy-Induced Nausea and Vomiting. JCO Glob Oncol. 2024 Jun;10:e2400130. doi: 10.1200/GO.24.00130.
- Individual participant dataSharing planned: Undecided. IPD may be shared depending on prevailing local institutional policies.
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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.
Heber Rew Bright, MPharm principal investigator
Christian Medical College, Vellore, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capsaicin in people with Chemotherapy-induced Nausea and Vomiting, run by Christian Medical College, Vellore, India at 1 site in India.
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 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: finished, as of the sponsor's last update on 20 May 2022. 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 India. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nausea (time frame: Within 15 days of chemotherapy). 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?
On the ClinicalTrials.gov record for NCT04918069, 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 20 May 2022.