Anti nausea treatment based on individual genetic alterations (SNP) and simultaneous test of the validity of acupressure in conjuction with chemotherapy in women with breast cancer.

Randomized multicenter study of Acupressure combined with personalized antiemetics based on genetic variations (SNPs) in women undergoing neoadjuvant or adjuvant chemotherapy EC / FEC against breast cancer. - AkupresSNP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000658-39-SE

Enrollment

840

Registered

2016-03-01

Start date

2016-07-11

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea in conjuction with neoadjuvant or adjuvant chemotherapy (FEC/EC) for patients with breast cancer.

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: Betamethasone CAS Number: 378-44-9 Other descriptive name: BETAMETHASONE Pharmaceutical Form: Concentrate and solvent for solution for injection INN o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Until 31 Dec 2020: Women with verified breast cancer planed for first neoadjuvant or adjuvant FEC/EC chemotherapy an Age = 18 years From 2021: Patients with a cancer diagnosis that are planned for potentially emetogenic chemotherapy Knowledge of the Swedish language Informed consent in writing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 590 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

Exclusion criteria

Exclusion criteria: ? Distant metastases in patients treated in an adjuvant setting ? Previous treatment with chemotherapy ? Unable to understand information about the study Only until 31 Dec 2020: Contra indication against betamethasone

Design outcomes

Primary

Measure	Time frame
Main Objective: The part study SNP based personalised antiemetic treatment (stopped 31 dec 2020): To study if patients, risk classified by SNP based risk assessment for chemotherapy induced nausea, treated with two different doses of corticosteroid (betamethasone) as part of the antiemetic treatment, receive the same antiemetic effect compared to patients treated with standard antiemetic treatment. The part study Acupressure (continues in 2021): To study if there is any difference in the antiemetic effect in patient’s treatment with acupressure compared to patients treated with placebo acupressure. ;Secondary Objective: In the part study SNP based personalised antiemetic treatment (stopped 31 dec 2020): Nausea in the acute and delayed time period. Intensity of nausea Frequency of vomiting. To compare a structured anamnesis on previous nausea experience to the SNP decided risk in terms of actual nausea To verify earlier found results, on relevant SNPs for the risk of nausea in a larger patient cohort. Secondary objectives part study acupressure (continues in 2021):. Nausea in the acute and delayed time period. Intensity of nausea Frequency of vomiting in the acute and delayed time period. Objective of both part studies. Differences in wellbeing and quality of life between the different treatment arms before and after 10 days after treatment with chemotherapy (according to the diary and EORTC QLQ-30) ;Primary end point(s): Patient reported nausea defined as at least one occasion of nausea (light, medium or severe) according to the patient diary at any time during 10 days following chemotherapy. ;Timepoint(s) of evaluation of this end point: During 10 days after initiation of treatment	—

Measure

Time frame

Main Objective: The part study SNP based personalised antiemetic treatment (stopped 31 dec 2020): To study if patients, risk classified by SNP based risk assessment for chemotherapy induced nausea, treated with two different doses of corticosteroid (betamethasone) as part of the antiemetic treatment, receive the same antiemetic effect compared to patients treated with standard antiemetic treatment. The part study Acupressure (continues in 2021): To study if there is any difference in the antiemetic effect in patient’s treatment with acupressure compared to patients treated with placebo acupressure. ;Secondary Objective: In the part study SNP based personalised antiemetic treatment (stopped 31 dec 2020): Nausea in the acute and delayed time period. Intensity of nausea Frequency of vomiting. To compare a structured anamnesis on previous nausea experience to the SNP decided risk in terms of actual nausea To verify earlier found results, on relevant SNPs for the risk of nausea in a larger patient cohort. Secondary objectives part study acupressure (continues in 2021):. Nausea in the acute and delayed time period. Intensity of nausea Frequency of vomiting in the acute and delayed time period. Objective of both part studies. Differences in wellbeing and quality of life between the different treatment arms before and after 10 days after treatment with chemotherapy (according to the diary and EORTC QLQ-30) ;Primary end point(s): Patient reported nausea defined as at least one occasion of nausea (light, medium or severe) according to the patient diary at any time during 10 days following chemotherapy. ;Timepoint(s) of evaluation of this end point: During 10 days after initiation of treatment

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Secondary

Measure	Time frame
Secondary end point(s): In both part studies: Acute nausea: Occurrence of at least one occasion of nausea (any grade) during the first 24 hours after chemotherapy Delayed nausea: Occurrence of at least one occasion of nausea (any grade) during 24 hours until 10 days after chemotherapy. Intensity of nausea: Occurrence of at least one occasion of intense nausea (VAS >/=5) during 10 days after chemotherapy. Vomiting frequency: Number of days with vomiting during 10 days after chemotherapy Well-being: According to the diary classified as very bad, bad, good or very good. Quality of Life: According to EORTC's scoring manual ;Timepoint(s) of evaluation of this end point: Acute nausea: during the first 24 hours after chemotherapy Delayed nausea: 24 hours until 10 days after chemotherapy. Intensity of nausea: At any time during 10 days after chemotherapy. Vomiting frequency: During 10 days after chemotherapy Well-being and quality of life will be evaluated before start of treatment and after 10 Days	—

Measure

Time frame

Secondary end point(s): In both part studies: Acute nausea: Occurrence of at least one occasion of nausea (any grade) during the first 24 hours after chemotherapy Delayed nausea: Occurrence of at least one occasion of nausea (any grade) during 24 hours until 10 days after chemotherapy. Intensity of nausea: Occurrence of at least one occasion of intense nausea (VAS >/=5) during 10 days after chemotherapy. Vomiting frequency: Number of days with vomiting during 10 days after chemotherapy Well-being: According to the diary classified as very bad, bad, good or very good. Quality of Life: According to EORTC's scoring manual ;Timepoint(s) of evaluation of this end point: Acute nausea: during the first 24 hours after chemotherapy Delayed nausea: 24 hours until 10 days after chemotherapy. Intensity of nausea: At any time during 10 days after chemotherapy. Vomiting frequency: During 10 days after chemotherapy Well-being and quality of life will be evaluated before start of treatment and after 10 Days

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Countries

Sweden

Contacts

Public ContactDelmy Oliva

Region Jönköpings län

delmy.oliva@rjl.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026