NCT07722156

Brief Summary

Breast cancer is frequently accompanied by chronic inflammation, malnutrition, and reduced quality of life, all of which may compromise treatment response and clinical outcomes. Nutritional interventions with immunomodulatory and anti-inflammatory properties have the potential to improve these conditions. Channa striata is rich in high-quality protein, albumin, and essential amino acids that support nutritional recovery and tissue repair, while Curcuma contains curcumin, a bioactive compound with well-established anti-inflammatory and antioxidant effects. This study aims to evaluate the effect of combined Channa striata and Curcuma supplementation on nutritional status, serum interleukin-6 (IL-6) levels, and quality of life in patients with breast cancer undergoing treatment. The findings are expected to provide evidence for the use of this nutritional supplementation as a complementary strategy to improve clinical outcomes, reduce systemic inflammation, and enhance the overall well-being of breast cancer patients.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
6mo left

Started Aug 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Jan 2027

First Submitted

Initial submission to the registry

July 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 15, 2026

Last Update Submit

July 19, 2026

Conditions

Keywords

Breast cancer; Channa striata; Curcuma; Nutritional status; Interleukin-6 (IL-6); Quality of life; Nutritional supplementation; Inflammation.Breast cancer, Channa striata Curcuma, Interleukin-6, Quality of life

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    This study evaluated changes in BMI, following one month of Channa striata and Curcuma supplementation.

    baseline post intervention 4 weeks

Secondary Outcomes (1)

  • interleukin - 6

    Baseline and 1 month after intervention

Study Arms (2)

experimental : channa striata and curcuma

EXPERIMENTAL

intervention group

Dietary Supplement: channa striata and curcuma

control

PLACEBO COMPARATOR

control group

Dietary Supplement: Maltodextrin (Placebo)

Interventions

channa striata and curcumaDIETARY_SUPPLEMENT

Participants in the intervention group received oral supplementation consisting of 5 g of Channa striata and 250 mg of Curcuma daily for one month, while participants in the control group received a maltodextrin placebo daily for the same duration.

experimental : channa striata and curcuma
Maltodextrin (Placebo)DIETARY_SUPPLEMENT

Participants in the control group received a placebo consisting of maltodextrin daily for one month.

control

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with breast cancer aged ≥18 years who were undergoing chemotherapy.
  • Patients with a body mass index (BMI) of 18-29 kg/m².
  • Patients currently receiving chemotherapy for breast cancer.
  • Patients with serum albumin levels of 2.0-3.5 g/dL.
  • Patients who were able to consume oral food and were willing to participate in the study by providing written informed consent.

You may not qualify if:

  • Patients with chronic kidney disease, renal failure, or kidney infection.
  • Patients with a known allergy to fish or Channa striata (snakehead fish) albumin-derived products.
  • Patients receiving other protein or amino acid supplements during the study period.
  • Patients who were non-compliant or discontinued the intervention before completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition Department

Medan, North Sumatera, Indonesia

Location

MeSH Terms

Conditions

Breast NeoplasmsInflammation

Interventions

turmeric extractmaltodextrin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Damayanti Tridah Ayu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 23, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations