Nutritional Supplement Based on Myo-inositol-D-chiro-inositoln in Long-term Survivors of Lymphoma

NCT05410314 | Completed

• 1 other identifier: UNIBA
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The progressive improvement of lymphoma treatment has led to an important prolongation of patient survival and life expectancy. Therefore, the principal International scientific societies of oncology, recommend Long-term Survivors of Lymphoma to join fertility programs. Specifically, fertile age patients should be assisted by a multi-disciplinary team including specialists dedicated to fertility preservation in oncology, in order to support the completion of the reproductive project. In general population, the use of Inositol was spready considered an effectives choice to contrast ovarian dysfunction with consequently improvement of reproductive outcomes, so it may represent an adjuvant strategy for this purpose. Therefore, the investigators conducted a pilot study to evaluate the potentialities of this nutritional supplement with the aim to optimize the reproductive function in Long-term Survivors of Lymphoma. Despite the limited number of cases and short observational time, this pilot investigation could represent a potential cornerstone for further insights, discussions, and applications

Conditions

Lymphoma, Hodgkin; Menstrual Irregularity; Fertility Disorders

Outcome Measures

Primary Outcomes (1)

• Number of Lymphoma long-term survivors treated with myo-inositol-D-chiro-inositol: evaluation of the results on the reproduction apparatus

  The investigatirs conducted a prospective observational controlled study on two groups: the first one (A group) underwent oral supplementation with myo-inositol-D-chiro-inositol for 12 months; the second group (B group) underwent follow-up without any nutritional supplement for 12 months.Moreover, the investigators reported for each patient the menstrual frequency ( oligomenorrhea \<25 days , normal flow 25-36 days , polymenorrhea \>36 days), the duration of the cycle (short \< 3 days, normal: 3-7 days , long \>7 days), the amount of the menstrual cycle (poor \<30 ml, normal 30-80 ml, \>80 ml abundant) and dysmenorrhea and dyspareunia (visual analogue scale VAS pain scale = 1 -10).In addition, results of blood tests and clinical data about menstrual regularity and dysmenorrhea, were reported on the same database.In addition, results of blood tests and clinical data about menstrual regularity and dysmenorrhea, were reported on the same database.

  12 months

Study Arms (1)

cHL (85%) and DLBCL (15%)

Patients enrolled in this study are cHL (85%) and DLBCL (15%) long-term survivors, treated mainly with ABVD+ radiotherapy (not under diaphragmatic and pelvic irradiation), without relapse (during quinquennial follow-up) who are followed at the clinic dedicated to fertility in oncology of our Department, which is a regional referral center for this purpose. Therefore, the investigators conducted a prospective observational controlled study on two groups: the first one (A group) underwent oral supplementation with MIC for 12 months; the second group (B group) underwent follow-up without any nutritional supplement for 12 months

Drug: Myo-Inositol and D-Chiro-Inositol (MIC)

Interventions

Myo-Inositol and D-Chiro-Inositol (MIC) DRUG

Both groups were followed up for 12 months, in T0 (during first evaluation), and T12 (after twelve months) with blood test for AMH (ng/ml).

cHL (85%) and DLBCL (15%)

Eligibility Criteria

• Age: 25 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

From January 2020 to January 2021, 90 Long-term Survivors of Lymphoma female patients, average age 34 years (range 25-44) were considered eligible for the study. Each patient was informed about the procedures and signed informed consent before the surgery to allow data collection for research purposes.

You may qualify if:

• Patients with Classical Hodgkin lymphoma (cHL) and Diffuse Large B-cell lymphoma (DLBCL) long survival

Sponsors & Collaborators

• University of Bari Aldo Moro: lead

Study Sites (1)

IRCCS - Istituto Oncologico"Giovanni PaoloII"

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Hodgkin Disease; Menstruation Disturbances

Interventions

Inositol

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNIBA

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 8, 2022
• Study Start: February 7, 2020
• Primary Completion: February 7, 2021
• Study Completion: December 7, 2021
• Last Updated: June 8, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)